Triathlon Tritanium Knee Outcomes Study
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics

 
 
Orthopaedics 
 
 
 
 
 
 
 
Triathlon Tritanium Knee Outcomes Study 
 
CLINICAL PROTOCOL 
A prospective, post-market, multi-center study of the outcomes of the 
Triathlon Tritanium Knee System 
 
 
 
Sponsor: 
Stryker Orthopaedics 
325 Corporate Drive 
Mahwah, NJ  07430 
201-831-5000 
Study Product: 
Triathlon Tritanium Tibia and Patella 
Protocol Number: 
74 
510(k) Clearance  Number: 
K123486 & K132624 
 
Version 2 
Date:  January 30, 2014 
CONFIDENTIAL 
 
This document is confidential and the property of Stryker Orthopaedics.  No 
part of it may be transmitted, reproduced, published or used by other persons 
without prior written authorization from Stryker.

 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Page i 
 
 
 
 
 
Protocol Change History 
 
 
Version 
Description 
Changed By 
1 
New 
Michael A. Pelosi 
2 
Added cemented treatment group 
Updated evaluation schedule (removed FJS-12, LEAS and 
EQ5D) 
Added evaluation schedule for cemented treatment group 
Updated statistical section & sample size 
Updated draft specs for CRFs 
Updated component listing 
Updated 6 month visit interval window 
Michael A. Pelosi 

Triathlon Tritanium Knee Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 2 
 
CONFIDENTIAL 
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Page ii 
Table of Contents 
STUDY SYNOPSIS ....................................................................................................................................... 2 
COHORT 1 (CEMENTLESS) EVALUATION SCHEDULE .......................................................................... 8 
COHORT 2 (CEMENTED) EVALUATION SCHEDULE .............................................................................. 9 
1 
INTRODUCTION ................................................................................................................................ 10 
1.1 
BACKGROUND .............................................................................................................................. 10 
1.2 
STUDY DEVICE ............................................................................................................................. 11 
1.3 
PRECLINICAL DATA ...................................................................................................................... 12 
1.4 
CLINICAL DATA TO DATE............................................................................................................... 14 
2 
STUDY OBJECTIVES ....................................................................................................................... 14 
2.1 
EFFICACY .................................................................................................................................... 14 
2.1.1 
Primary .................................................................................................................................. 14 
2.1.2 
Secondary ............................................................................................................................. 15 
2.1.3 
Additional Data Collection ..................................................................................................... 15 
2.2 
SAFETY ....................................................................................................................................... 17 
3 
CLINICAL STUDY PLAN ................................................................................................................... 17 
3.1 
STUDY DESIGN ............................................................................................................................ 17 
3.2 
NUMBER OF CENTERS .................................................................................................................. 17 
3.2.1 
Centers for Standard Data Collection ................................................................................... 17 
3.3 
NUMBER OF SUBJECTS ................................................................................................................. 18 
3.4 
ESTIMATED STUDY DURATION ...................................................................................................... 18 
4 
ELIGIBILITY ....................................................................................................................................... 18 
4.1 
INCLUSION CRITERIA .................................................................................................................... 19 
4.2 
EXCLUSION CRITERIA ................................................................................................................... 19 
5 
SUBJECT ENROLLMENT ................................................................................................................. 19 
5.1 
TREATMENT ASSIGNMENT ............................................................................................................ 19 
5.2 
RANDOMIZATION .......................................................................................................................... 20 
6 
DEVICE DESCRIPTION .................................................................................................................... 20 
6.1 
STUDY DEVICE ............................................................................................................................. 20 
6.2 
CONTROL DEVICE ........................................................................................................................ 23 
6.3 
DEVICE RETRIEVAL PROCESS ....................................................................................................... 24 
7 
EVALUATIONS .................................................................................................................................. 25 
7.1 
PREOPERATIVE VISIT ................................................................................................................... 25 
7.2 
SURGERY .................................................................................................................................... 26 
7.3 
6-WEEK VISIT ............................................................................................................................... 26 
7.4 
6-MONTH VISIT ............................................................................................................................. 26 
7.5 
ANNUAL FOLLOW-UP VISITS .......................................................................................................... 26 
7.5.1 
Cohort 1 (cementless) Annual Follow-up Visits .................................................................... 26 
7.5.2 
Cohort 2 (cemented) Annual Follow-up Visits ....................................................................... 27 
8 
ADVERSE EVENTS ........................................................................................................................... 27 
8.1 
REPORTING OF ADVERSE EVENTS ................................................................................................ 27 
8.2 
GENERAL ADVERSE EVENT DEFINITIONS ....................................................................................... 29 
8.3 
STUDY SPONSOR NOTIFICATION BY INVESTIGATOR ........................................................................ 30 
8.3.1 
Ethics Committee/Institutional Review Board Notification by Investigator ............................ 31 
8.4 
RECORDING OF ADVERSE EVENTS ................................................................................................ 32 

Triathlon Tritanium Knee Outcomes Study 
 
 
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Page iii 
8.5 
MEDICAL MONITORING ................................................................................................................. 32 
9 
STATISTICAL PLAN ......................................................................................................................... 32 
9.1 
EFFICACY .................................................................................................................................... 32 
9.1.1 
Primary Efficacy Parameters ................................................................................................. 32 
9.1.2 
Secondary Efficacy Parameters ............................................................................................ 32 
9.1.3 
Primary Efficacy Analysis ...................................................................................................... 33 
9.1.4 
Secondary Efficacy Analysis ................................................................................................. 33 
9.2 
SAFETY ....................................................................................................................................... 34 
9.2.1 
Safety Parameters ................................................................................................................. 34 
9.2.2 
Safety Analyses ..................................................................................................................... 34 
9.3 
MISSING DATA ............................................................................................................................. 34 
9.4 
STATISTICAL METHODOLOGY ........................................................................................................ 34 
9.4.1 
Data Summary....................................................................................................................... 34 
9.4.2 
Sample Size Justification ...................................................................................................... 35 
9.4.3 
Interim Analyses .................................................................................................................... 35 
9.4.4 
Analysis Population ............................................................................................................... 36 
10 
STUDY PROCEDURES ..................................................................................................................... 36 
10.1 
SUBJECT RECRUITMENT AND SCREENING ..................................................................................... 36 
10.2 
PATIENT INFORMED CONSENT AND GUIDELINES............................................................................. 36 
10.3 
EARLY WITHDRAWAL OF SUBJECTS .............................................................................................. 37 
11 
DATA MANAGEMENT ...................................................................................................................... 39 
11.1 
DATABASE ................................................................................................................................... 39 
11.2 
CONFIDENTIALITY ......................................................................................................................... 39 
11.3 
SOURCE DOCUMENTS .................................................................................................................. 40 
11.4 
ELECTRONIC CASE REPORT FORMS.............................................................................................. 40 
11.5 
DATA CLARIFICATION REQUESTS .................................................................................................. 41 
11.6 
PROTOCOL DEVIATIONS ............................................................................................................... 41 
11.7 
RECORDS RETENTION .................................................................................................................. 41 
12 
RISK/BENEFIT ASSESSMENT ......................................................................................................... 42 
12.1 
RISK CATEGORY .......................................................................................................................... 42 
12.2 
POTENTIAL RISK .......................................................................................................................... 42 
12.3 
EXPECTED COMPLICATIONS .......................................................................................................... 43 
12.4 
PROTECTION AGAINST RISKS........................................................................................................ 43 
12.5 
POTENTIAL BENEFITS TO THE SUBJECT ......................................................................................... 44 
13 
STUDY MONITORING, AUDITING, AND INSPECTING .................................................................. 44 
13.1 
STUDY MONITORING PLAN ............................................................................................................ 44 
13.2 
AUDITING AND INSPECTING ........................................................................................................... 45 
14 
ETHICAL CONSIDERATIONS .......................................................................................................... 45 
15 
STUDY FINANCES ............................................................................................................................ 46 
15.1 
FUNDING SOURCE ........................................................................................................................ 46 
15.2 
CONFLICT OF INTEREST ................................................................................................................ 46 
15.3 
SUBJECT STIPENDS OR PAYMENTS ............................................................................................... 46 
16 
PUBLICATION PLAN ........................................................................................................................ 47 
17 
REFERENCES ................................................................................................................................... 49 
 
 
 

Triathlon Tritanium Knee Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page iv 
List of Appendices 
 
Appendix A 
 
FDA 510(k) Clearance Letters 
Appendix B 
 
Suggested Radiographic Technique  
Appendix C 
 
Retrieved Implant Analysis Protocol  
Appendix D 
 
Study Advertisements  
Appendix E 
 
Model Informed Patient Consent  
Appendix F 
 
Draft Specifications for Electronic Case Report Forms  
Appendix G 
 
Product Labeling  
Appendix H 
 
Patient Retention 
Appendix I  
 
Component listing 
 
 
 
 

Triathlon Tritanium Knee Outcomes Study 
 
 
Stryker Orthopaedics Clinical Study Protocol 
 
 
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Page v 
List of Figures and Tables 
FIGURE 1: TRIATHLON TRITANIUM TIBIAL BASEPLATE AND PATELLA ............................. 22 
FIGURE 2: ADVERSE EVENT DECISION TREE ...................................................................... 28 
 
 
 
 
 

Triathlon Tritanium Knee Outcomes Study 
    
Stryker Orthopaedics Clinical Study Protocol  
 
 
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Page vi 
 
List of Abbreviations 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AP 
Anteroposterior 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CP 
Commercially Pure 
CR 
Cruciate Retaining 
CSM 
Clinical Study Manager 
DCR 
Data Clarification Request 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
International Conference of Harmonisation Good Clinical Practice 
HHS 
Harris Hip Score 
HIPAA 
Health Insurance Portability and Accountability Act 
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
KSS 
Knee Society Score, 2011 
LRM 
Laser Rapid Manufacturing 
ML 
Mediolateral 
OKS 
Oxford Knee Score 
PA 
Periapatite 
PCL 
Posterior Cruciate Ligament 
PER 
Product Experience Report 
PI 
Principal Investigator 
PMMA  
Polymethylacrylate 
PRO 
Patient Reported Outcome 
PS 
Posterior Stabilized 
QOL 
Quality of Life 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
SC 
Study Coordinator 
SF-12 
Short Form-12 
TKA 
Total Knee Arthroplasty 
UADE 
Unanticipated Adverse Device Effect 
UHMWPE 
Ultra High Molecular Weight Polyethylene
 
 

Triathlon Tritanium Knee Outcomes Study 
 
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Study Synopsis 
 
Title 
A prospective, post-market, multi-center study of the outcomes of the 
Triathlon Tritanium Knee System   
Short Title 
Triathlon Tritanium Knee Outcomes Study 
Protocol Number 
74 
Phase 
Post-market 
Methodology 
This study is a prospective, non-randomized evaluation of the 
Triathlon Tritanium Knee System for primary total knee arthroplasty 
(TKA) with a cementless application in a consecutive series of 
patients who meet the eligibility criteria.   
 
Cohort 1 (cementless): The first 356 cases enrolled will receive the 
Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, 
Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial 
Insert. All components in this cohort must be used in a cementless 
application.    
 
Cohort 2 (cemented): An additional 144 cases will receive the 
Triathlon Cemented Tibial Baseplate, Triathlon Cemented Patella, 
Triathlon CR or PS Cemented Femur and Triathlon Tibial Insert. All 
components in this cohort must be used in a cemented application.   
 
The study uses literature control for the primary endpoint and a 
concurrent control (Cohort 2) for secondary endpoints. 
Study Duration 
Approximate 12-year total duration 
 Enrollment period of 24 months  
 Follow-up of each primary Cohort 1 (cementless)TKA case to 10 
years 
 Follow-up of each primary Cohort 2 (cemented) TKA case to 5 
years.
Study Center(s) 
5-10 centers. The same center may be included in both arms.  
Conversely, a center may choose to participate in only a single arm. 

Triathlon Tritanium Knee Outcomes Study 
 
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Hypothesis 
The success rate of the Triathlon Tritanium Knee, defined as 
absence of revision for aseptic loosening of the tibial baseplate at 2 
years, is no worse than rates reported in the literature for cemented 
devices. 
Objective(s) 
Primary: 
To compare the rate of aseptic loosening of the Triathlon Tritanium 
Tibial Baseplate with rates reported in the literature for cemented 
tibial baseplates at 2 years postoperative. 
 
Secondary Objectives: 
To assess the Kaplan-Meier survival curves of the Triathlon Tritanium 
Tibial Baseplate and Triathlon Tritanium Patella and compare them 
with those reported for cemented knee components in the literature.  
The overall revision rate will evaluate all-cause revision and removal 
rates of the Triathlon Tritanium Tibial Baseplate and Triathlon 
Tritanium Patella.  
 
To compare functional scores and Patient Reported Outcomes 
(PROs) between Cohort 1 (cementless) and Cohort 2 (cemented) at 
2 years postoperative.  The following outcomes measures will be 
collected: 
 
2011 Knee Society Score (2011 KSS)  
 
Oxford Knee Score (OKS)  
 
Short Form-12 (SF-12)  
 

Triathlon Tritanium Knee Outcomes Study 
 
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Additional Data 
Collection 
 
Subject demographics and medical histories are collected (age, 
gender, primary diagnosis, BMI, comorbidities, medications 
used, smoking history, alcohol use, education level, employment 
status, confounding orthopedic problems, etc.). 
 
 
2011 KSS, OKS and SF-12 will be presented with respect to 
improvement from preoperative scores for the cohorts according 
to their respective evaluation schedules.   
 
 
Assessment of radiographic outcomes using Anteroposterior 
(AP), Mediolateral (ML) and Merchant radiographs for the 
cohorts according to their respective evaluation schedules. 
. 
 
A Follow-up Questionnaire is administered to assess patient 
satisfaction, pain, study device survivorship and capture adverse 
events (AEs) for the cohorts according to their respective 
evaluation schedules. 
 
 
Collection and evaluation of device related AEs and 
unanticipated adverse device effects (UADEs). 
Number of Subjects 
A total of 500 cases will be enrolled in the study.  
 
Cohort 1 (cementless): 356 cementless cases 
Cohort 2 (cemented): 144 cemented cases  
 
 
Cases must receive the appropriate study device to count toward 
enrollment. 

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Diagnosis and Main 
Inclusion/Exclusion 
Criteria 
Inclusions:
1. Patient has signed an IRB/EC approved; study specific 
Informed Patient Consent Form. 
 
2. Patient is a male or non-pregnant female age 18-75 years at 
time of study device implantation. 
 
3. Patient has a diagnosis of Non-Inflammatory Degenerative 
Joint Disease (NIDJD). 
 
4. Patient is a candidate for primary cementless total knee 
replacement, including a resurfaced patella. 
 
5. Patient is willing and able to comply with postoperative 
scheduled clinical and radiographic evaluations and 
rehabilitation. 
 
Exclusions: 
1. Patient has a Body Mass Index (BMI) > 40. 
 
2. Patient has a diagnosis of avascular necrosis or inflammatory 
arthritis. 
 
3. Patient has an active or suspected latent infection in or about 
the affected knee joint at time of study device implantation. 
 
4. Patient has a neuromuscular or neurosensory deficiency, 
which limits the ability to evaluate the safety and efficacy of 
the device. 
 
5. Subject is diagnosed with a systemic disease (e.g. Lupus 
Erythematosus) or a metabolic disorder (e.g. Paget’s 
Disease) leading to progressive bone deterioration. 
 
6. Patient is immunologically suppressed or receiving steroids in 
excess of normal physiological requirements (e.g. > 30 days). 
 
7. Patient is diagnosed with lumbar radicular pain. 
 
8. Patient has a known sensitivity to device materials. 
 
9. Patient is a prisoner. 
 

Triathlon Tritanium Knee Outcomes Study 
 
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Stryker Orthopaedics Clinical Study Protocol 
 
 
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Study Device 
Cohort 1 (cementless) 
Required Components for the cementless cohort: 
 
 
Triathlon Tritanium Tibial Baseplate 
 
Triathlon Tritanium Patella 
 
All components must be used in a cementless application. 
Ancillary Devices 
Cohort 1 (cementless) 
All Stryker components must be used according to this study 
protocol.  The following ancillary devices are permissible: 
 
 
Triathlon Cruciate Retaining (CR) or Posterior Stabilized (PS) 
Beaded Femur with Periapatite (PA) 
 
Triathlon Tibial Inserts 
 
All components must be used in a cementless application. 
Control Device 
Cohort 2 (cemented) 
Required Components for the cemented cohort: 
 
 
Triathlon Tibial Baseplate 
 
Triathlon Patella 
 
Triathlon CR or PS Femoral Component 
 
Triathlon Tibial Inserts 
 
All components must be used in a cemented application. 
Reference Therapy 
Literature control (cemented tibial baseplates) 
Concurrent control (Triathlon Cemented) 

Triathlon Tritanium Knee Outcomes Study 
 
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Stryker Orthopaedics Clinical Study Protocol 
 
 
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Statistical 
Methodology 
Primary Objective:
 
2-year success rate of the Triathlon Tritanium Tibial Baseplate 
with an endpoint of revision for aseptic loosening will be 
compared to a 99% success rate with a 2% noninferiority margin. 
 
Secondary Objectives: 
 
The Kaplan-Meier survival curves for all-cause revision/removal 
of the Triathlon Tritanium Tibial Baseplate and Triathlon Tritanium 
Patella will be displayed. 
 
 
The all-cause revision/removal rates of the Triathlon Tritanium 
Tibial Baseplate and Triathlon Tritanium Patella will be compared 
with those reported for cemented knee components in the 
literature. 
 
 
The 2011 KSS scores, SF-12, and OKS scores at 2 years 
postoperative will be compared between Cohort1 (cementless) 
and Cohort 2 (cemented) using applicable statistical methods. 
 

Triathlon Tritanium Knee Outcomes Study                               
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Stryker Orthopaedics Clinical Study Protocol  
 
 
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Cohort 1 (Cementless) Evaluation Schedule 
Evaluation 
 
Preop 
X-rays 
(-1 yr) 
CRFs 
(-4 mos) 
Intraop 
6 wks 
(+ 3 wks) 
6 mo 
(-14 - + 4 wks) 
1 yr 
(+ 2 mos) 
2 yrs 
(+ 2 mos) 
3 yrs 
(+ 3 mos) 
4 yrs 
(+ 4 mos) 
5 yrs 
(+ 4 mos) 
Annually 
6, 7, 8, 9 yrs 
(+ 4 mos) 
10 yrs 
(+ 4 mos) 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
 
 
Demographics & Medical History 
X 
 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
 
 
Preoperative Functional Evaluation 
X 
 
 
 
 
 
 
 
 
 
 
Postoperitive Functional 
Evaluation 
 
 
X 
X 
X 
X 
 
 
X 
 
X 
OKS 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
SF-12 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
Radiographs: AP/ML/Merchant 
X 
 
X 
X 
X 
X 
 
 
X 
 
X 
Follow-up Questionnaire 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X: Evaluation is required for all cases. 
 
Functional Evaluation - The Functional Evaluations include the 2011 KSS, a standardized instrument with both patient reported outcomes and surgeon completed sections that evaluate function, 
satisfaction, expectations and range of motion. 
OKS - The Oxford Knee Score is a 12 item patient reported outcome questionnaire that evaluates function and pain after total knee arthroplasty. 
SF-12 - The SF-12 is a standardized 12 item patient reported outcome questionnaire that evaluates general health and well being. 
Follow-up Questionnaire - The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, study device survivorship and AEs. 
 
 
 

Triathlon Tritanium Knee Outcomes Study                               
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Stryker Orthopaedics Clinical Study Protocol  
 
 
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Cohort 2 (Cemented) Evaluation Schedule 
Evaluation 
 
Preop 
X-rays 
(-1 yr) 
CRFs 
(-4 mos) 
Intraop 
6 wks 
(+ 3 wks) 
6 mo 
(-14 - + 4 wks) 
1 yr 
(+ 2 mos) 
2 yrs 
(+ 2 mos) 
3 yrs 
(+ 3 mos) 
4 yrs 
(+ 4 mos) 
5 yrs 
(+ 4 mos) 
Inclusion/Exclusion 
X 
 
 
 
 
 
 
 
 
Demographics & Medical History 
X 
 
 
 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
 
 
Preoperative Functional Evaluation 
X 
 
 
 
 
 
 
 
 
Postoperitive Functional Evaluation 
 
 
X 
X 
X 
X 
 
 
X 
OKS 
X 
 
X 
 
X 
X 
X 
X 
X 
SF-12 
X 
 
X 
 
X 
X 
X 
X 
X 
Radiographs: AP/ML/Merchant 
X 
 
X 
X 
X 
X 
 
 
X 
Follow-up Questionnaire 
 
 
 
 
 
 
X 
X 
X 
X: Evaluation is required for all cases. 
 
Functional Evaluation - The Functional Evaluations include the 2011 KSS, a standardized instrument with both patient reported outcomes and surgeon completed sections that evaluate function, 
satisfaction, expectations and range of motion. 
OKS - The Oxford Knee Score is a 12 item patient reported outcome questionnaire that evaluates function and pain after total knee arthroplasty. 
SF-12 - The SF-12 is a standardized 12 item patient reported outcome questionnaire that evaluates general health and well being. 
Follow-up Questionnaire - The Follow-up Questionnaire is a short patient questionnaire intended to provide information on patient satisfaction, pain, study device survivorship and AEs. 

Triathlon Tritanium Knee Outcomes Study                                                                                                          Page 10 
Stryker Orthopaedics Clinical Study Protocol  
 
 
Version 2 
CONFIDENTIAL 
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This document is a protocol for a human research study.  This study will be conducted in 
compliance with the protocol, Good Clinical Practice (GCP) Standards, associated 
Federal regulations and all applicable research requirements.  
1.1 Background 
Primary TKA has consistently shown to be successful in relieving pain and improving function 
for those experiencing difficulties of degenerative joint disease1. 
 
The Triathlon Knee System, a predecessor to the Triathlon Tritanium Knee System, is designed 
to meet patients’ reasonable expectations for lifestyle recovery.  It is designed to provide 
patients with more natural motion and the potential for greater implant longevity.  As a next-
generation knee replacement, the Triathlon Knee System is designed to more closely mimic 
natural knee motion, providing mobility with stability through or exceeding 150◦ of flexion2.  The 
Triathlon design criteria are realized through component features including an anatomic radius, 
deep flexion radius and flared posterior condyles, a patented Rotary Arc and an anatomic 
patellofemoral track. 
 
Studies of kinematics and biomechanics have identified a constant radius in natural knee motion 
centered about the transepicondylar axis3,4,5.  The Triathlon Knee System is the first of its kind 
with a patented anatomic radius.  Centering the anatomic radius about the transepicondylar axis 
provides ligament isometry, not only in full extension and 90◦ of flexion, but through the entire 
range of motion.  The anatomic radius is designed to mimic natural knee motion, enhancing 
stability and mobility in activities such as descending and ascending stairs or any similar activity 
requiring stability at deep flexion angles. 
 
Cementless fixation in TKA was initially introduced in the early 1980s6.  As materials and 
designs have evolved, cementless fixation has become a growing trend in knee reconstruction, 
mainly due to the changing demographics of the TKA population7.  Cementless components 
offer the potential advantage of a biologic interface between the bone and implants, which could 
demonstrate the greatest advantage in long-term durable fixation in the follow-up of younger 
patients undergoing TKA7. 
1 Introduction 

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The Triathlon Tritanium Knee System features the Tritanium advanced fixation technology.  
Tritanium technology provides a three-dimensional, commercially pure (CP) Titanium matrix that 
resembles trabecular bone, allowing for enhanced fixation8 and joint stability.  Studies have 
shown the superiority of 3-D surfaces when compared to 2-D surfaces, as well as improved 
biological fixation with CP Titanium as compared to alloys9. 
 
Tritanium porous surface technology allows the component to be press fit into the prepared 
tibia.  The key feature of this Tritanium technology porous coating is that it has a higher pore 
volume than other standard porous coatings, which may allow greater biologic fixation when 
press fit.   An animal study on a similar porous tantalum coating with a volume porosity of 75-
80% showed superior mechanical and biologic fixation properties when compared to a coating 
with other surface treatments10. 
 
The Triathlon Tritanium Knee System incorporates the Tritanium porous biologic fixation 
technology with the Triathlon Knee System design, which provides orthopaedic surgeons with 
enhanced biologic fixation technology for primary cementless TKA indications to intraoperatively 
address initial and long-term fixation.  
1.2 Study Device 
The Triathlon Tritanium Tibial Baseplate was cleared for use under FDA 510(k) K123486 on 
May 3, 2013.  The Triathlon Tritanium Patella was cleared for use under FDA 510(k) K132624 
on November 26, 2013.  See Appendix A for the FDA 510(k) clearance letters.  
 
The Triathlon Tritanium Tibial Baseplate is indicated for cemented and uncemented use but 
must be used in a cementless, press-fit application for the purposes of this study protocol.   It is 
available in eight sizes and is manufactured from Ti-6Al-4V-ELI (ASTM F-136) and CP Titanium  
powder (ASTM F-1580) materials.  The bone contacting material on the fixation side of the 
baseplate is manufactured from CP Titanium, providing a porous surface.  The porous material 
is located on the underside of the tray and also on the proximal portion of the pegs and keel.   
 
The Triathlon Tritanium Patella is indicated for cemented or cementless use but must be used in 
a cementless, press-fit application for the purposes of this study protocol.  The patella is offered 
in asymmetric and symmetric designs.  The asymmetric design is available in five 

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superior/inferior dimensions and three dome thicknesses.  The symmetric design is offered in 
four diameters and the same three thicknesses. It is manufactured from Ultra-High Molecular 
Weight Polyethylene (UHMWPE, ASTM F648) and commercially pure titanium powder (CPTi, 
ASTM F1580).   
 
All study devices need to be used in a cementless, press-fit application for the purposes of this 
protocol. 
 
Details of the device design are presented in Section 6, Device Description.    
1.3  Preclinical Data 
The following bench tests (with test report numbers) were conducted with the Triathlon 
Tritanium Tibial Baseplate and Triathlon Tritanium Patella: 
  
Static Shear Test (RD-12-042) 
The mean moment for the Triathlon Tritanium Baseplate under load was 31.68 N-m.  
 
Evaluation of the Triathlon Tritanium Baseplate Locking Mechanism (RD-12-110) 
The locking tabs remained intact after 220,000 cycles as determined by visual and tactile 
inspection. 
 
Characterization of Tritanium Primary Baseplates under Impaction Loads (RD-12-055) 
The Tritanium Tibial Baseplate generated < 1mg of CP Titanium debris under 10 microns in 
size. 
   
Dynamic Shear Evaluation of the Triathlon Tritanium Tibial Peg (RD-12-056) 
The four pegs of the Tritanium Tibial Baseplate resisted the shear forces incurred by a dynamic 
load simulating stair descent activity for 1 million cycles or 10 years of simulated implant life. 
 
Triathlon Tritanium Baseplate Cantilever Fatigue Test (RD-12-111) 
All samples showed no fractures at the superior side of the Posterior Cruciate Ligament (PCL) 
or the outer strut on the inferior side of the tray at 10 million cycles of testing. 
 
 
 

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Triathlon Tritanium Baseplate Cantilever Fatigue Test after Impaction (RD-12-112) 
All samples showed no fractures at the superior side of the PCL or the outer strut on the inferior 
side of the tray at 10 million cycles and the baseplate was able to carry load throughout the 
entire test. 
 
Triathlon Tritanium Baseplate Anterior-Posterior Fatigue Test (RD-12-113) 
All samples completed the required 10 million cycles with no visual evidence of fracture. 
 
Wear Evaluation using Triathlon Tritanium Baseplates (RD-12-088) 
The study showed no difference in the backside wear rates of polyethylene inserts mated with 
standard Triathlon Cobalt Chromium baseplates compared to those mated with Triathlon 
Tritanium baseplates. 
 
Cement and Tritanium Shear Bond Strength Test (RD-12-118) 
The median fatigue strength of the cement/Tritanium (Patella) interface was calculated to be 
2251N.  The median fatigue strength of the cement/Tritanium (Baseplate) interface was 
calculated to be 3922N. 
 
Evaluation of the Triathlon Tritanium Patella under Adverse Loading Conditions (RD-12-
097) 
There were no signs of polyethylene fracture, dissociation of the polyethylene from the metal 
backing, or shear of the metal pegs after 1 million cycles of simulated adverse stair climbing 
kinematics and loading parameters at 10◦ of lateral tilt.  
 
Tritanium Patella Static Tensile Bond Strength of Poly/Metal Interface (RD-12-044) 
The mean peak load for the Triathlon Tritanium Patella for the tensile bond strength test was 
2428 N. 
 
Triathlon Tritanium Patella Static Shear Test (RD-12-115) 
The mean peak load for the Triathlon Tritanium Patella static shear test was 16,157 N. 
 
The results of the bench top testing conducted for the Triathlon Tritanium Tibial Baseplate and 
Patella identified acceptance criteria were met. 
 
Copies of all test reports are available at Stryker Orthopaedics.   

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1.4  Clinical Data to Date 
This study is the first Stryker sponsored multi-center prospective data collection on the Triathlon 
Tritanium Tibial Baseplate and Triathlon Tritanium Patella.   
 
The following articles are available from Stryker sponsored multi-center prospective studies on 
control device, the Triathlon cemented knee system: 
 
1. Harwin SF, Greene KA, Hitt K. Triathlon total knee arthroplasty: 4-year outcomes with a 
high-performance implant. J Knee Surg. 2008 Oct;21(4):320-6. 
 
2. Roth JS, Buehler KC, Shen J, Naughton M. Patient factors predict functional outcomes 
after cruciate retaining TKA: A 2-year follow-up analysis Journal of Arthroplasty, 2013 
Mar 21[Epub ahead of print]. 
 
3. Harwin SF, Greene KA, Hitt K. Early experience with a new total knee implant:  
maximizing range of motion and function with gender-specific sizing. Surg Technol Int. 
2007;16:199-205. 
 
4. Lozano S, Shen J, Doumato D: Functional Outcome in High Activity Demand Patients 
Following Total Knee Arthroplasty.  Orthopedics. 2012 May; 35(5): e681-90. 
 
5. Lozano S, Shen J, Doumato D: Cruciate Retaining vs. Posterior Stabilized Inserts in 
Total Knee Arthroplasty: Functional Outcomes Comparison. Journal of Arthroplasty. 
2012 July 16. [Epub ahead of print]. 
 
2 Study Objectives 
 
2.1 
Efficacy 
2.1.1 Primary 
The primary objective of this study is to evaluate the success rate of cementless 
primary total knee replacement with the Triathlon Tritanium Tibial Baseplate and 
Triathlon Tritanium Patella.  Success will be defined as absence of tibial baseplate 
revision for aseptic loosening at 2 years postoperative.  It is expected that the 
success rate of the Triathlon Tritanium Tibial Baseplate will be non-inferior to the 
selected reference rate of 99% at 2 years postoperative. 
 

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2.1.2 Secondary 
The secondary objectives of this study are: 
 
To assess the Kaplan-Meier survival curves of the Triathlon Tritanium Tibial 
Baseplate and Triathlon Tritanium Patella and compare them with those 
reported for cemented knee components in the literature.  The overall 
revision rate will evaluate all-cause revision and removal rates of the 
Triathlon Tritanium Tibial Baseplate and Triathlon Tritanium Patella.   
 
To compare 2011 KSS scores, SF-12 scores, and OKS scores between 
Cohort 1 (cementless) and Cohort 2 (cemented) at 2 years postoperative. 
2.1.3 Additional Data Collection 
 
Patient Demographics and Medical History: 
Preoperative clinical data are collected and include, but may not be limited to:  age, 
gender, operative side, primary diagnosis, height, weight, BMI, comorbidities, 
medications used, smoking history, alcohol use, education level, employment status 
and confounding orthopedic problems for both cohorts. 
 
Clinical Outcomes: 
Clinical outcomes are evaluated for both cohorts according to their respective 
evaluation schedules with the 2011 KSS. The 2011 KSS is comprised of five 
components (Demographics, Objective Knee Score, Patient Expectation, Patient 
Satisfaction Score and Functional Knee Score) that are physician and patient 
derived.11, The score includes elements of pain, motion and function.   
 
Patient Reported Outcomes: 
Pain, function and health related QOL will be evaluated for both cohorts according 
to their respective evaluation schedules with the SF-12, OKS and patient derived 
2011 KSS components.  The SF-12 is a 12 item patient self-assessment evaluating 
health and general well being.    The OKS is a 12 item patient reported outcome 
questionnaire that evaluates function and pain after total knee arthroplasty.    The 
2011 KSS subjective component is a patient reported outcome measure based on 
satisfaction with outcome, fulfillment of expectations and ability to perform functional 
activities.12   
 

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A Follow-up Questionnaire is administered annually for both cohorts according to 
their respective evaluation schedules to assess for patient satisfaction, pain, study 
device survivorship and to capture AEs.  This questionnaire provides the 
information necessary to create an accurate Kaplan-Meier Survival Curve.   
 
Radiographic Outcomes: 
Radiographs are taken and collected in the AP, ML and Merchant views for both 
cohorts according to their respective evaluation schedules (see Appendix B for the 
radiographic technique to be used). Radiographs are evaluated by an independent 
reviewer.  Parameters for radiographic failures will follow the guidelines that have 
been set by the Knee Society13.  The scoring system for each of the three 
components is determined by measuring the width of the radiolucent lines for each 
of the zones in millimeters for each of the three components.  The total widths are 
added for each zone for each of the three prostheses.   The total produces a 
numerical score for each component.   Failure is defined as a score of 10 or greater, 
regardless of symptoms.  A migrating or shifting prosthesis, with or without the 
disappearance of radiolucent lines, should be considered as a possible or 
impending failure regardless of the score.  Evaluation of the radiographs includes, 
but is not limited to, radiolucency and subsidence of the tibial baseplate, patellar 
component positioning, patellar tilt and/or displacement and osteolysis.   
 
Radiographic Performance Requirements: 
Radiographic analysis of the tibial component employs 3 zones (Zone 1 – Zone 3) 
in the ML view and five zones (Zone 1 – Zone 5) in the AP view; analysis of the 
patellar component employs five zones (Zone 1 – Zone 5) in the Merchant view.  
Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is 
defined as radiolucency present.   
 
Subsidence is defined as settling of the prosthetic component in bone, and is 
related to the distance between fixed bony landmarks on the tibia and the 
prosthesis.  It should be noted that Knee Society guidelines state that direct 
subsidence without angular movement cannot be detected because there is no 
reference point.14  
 

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Surgical Details: 
Intraoperative data collected includes, but may not be limited to, the duration of 
surgery, tourniquet time, blood loss, units of blood transfused, anesthesia used, 
prophylaxis, surgical technique, surgical approach, soft tissues released, implanted 
prostheses and complications.  
2.2 Safety 
All operative site events occurring at any time, as well as all serious adverse events (SAEs) 
occurring in the perioperative period (intraoperative to hospital discharge), are collected and 
compared to published data.  It is expected that the AE rates reported for the Triathlon Tritanium 
Tibial Baseplate and Patella will be comparable to those reported in the literature for cemented 
primary total knee systems on the market.  Details regarding AE definitions, recording and 
reporting are in Section 8 of this protocol, Adverse Events. 
 
3 Clinical Study Plan 
3.1 Study Design 
A prospective, post-market, multi-center design is employed.  Radiographs are assessed by an 
independent reviewer. 
3.2 Number of Centers 
 
3.2.1 Centers for Standard Data Collection 
 
Cases are to be enrolled at five to ten centers. The same center may be included in both 
arms. Conversely, a center may choose to participate in only a single arm.  The 
enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 
15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the 
number of participating centers.   Although a goal is presented, there is no maximum 
limit to the number of cases that a center may enroll.  In the event that a center far 
exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not 
to skew the data.  All participating centers will comply with the federal regulations 
regarding patient informed consent and Institutional Review Board (IRB) or Ethics 

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Committee (EC) approval.  Non-compliance of a study center may result in termination 
of the center’s participation in the study. 
3.3  Number of Subjects 
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon 
Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with 
PA and the Triathlon Tibial Insert.  All components in this cohort must used in a cementless 
application.  Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the 
Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial 
Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in 
this cohort must be used in a cemented application. 
3.4 Estimated Study Duration  
The enrollment period is estimated to be 24 months; cases for Cohort 1 (cementless) are 
evaluated as per the evaluation schedule until each case reaches 10 years. Cases for Cohort 2 
(cemented) are evaluated as per the evaluation schedule until each case reaches 5 years. The 
total is estimated study duration from enrollment to close-out activities is 12 years. 
 
To allow for a learning curve with the use of the device, enrollment of cases into the study 
commences when three cases have been completed at the center using the Triathlon Tritanium 
Tibial Baseplate and Triathlon Tritanium Patella.  
 
4 Eligibility 
 
The following criteria are used to distinguish patients eligible for enrollment into this study.  
Proper implant selection must consider design, fixation, and environmental variables including: 
patient weight, age, bone quality and size, activity level and preoperative level of health, as well 
as the surgeon’s experience and familiarity with the device.   
 
 
 

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4.1 
Inclusion Criteria 
1. Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form. 
2. Patient is a male or non-pregnant female age 18 – 75 years at time of study device 
implantation. 
3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 
4. Patient is a candidate for primary cementless total knee replacement, including a 
resurfaced patella. 
5. Patient is willing and able to comply with postoperative scheduled clinical and 
radiographic evaluations and rehabilitation. 
 
4.2 
Exclusion Criteria 
1. Patient has a Body Mass Index (BMI) > 40. 
 
2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis. 
 
3. Patient has an active or suspected latent infection in or about the affected knee joint at 
time of study device implantation. 
 
4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to 
evaluate the safety and efficacy of the device. 
 
5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic 
disorder (e.g. Paget’s Disease) leading to progressive bone deterioration. 
 
6. Patient is immunologically suppressed or receiving steroids in excess of normal 
physiological requirements (e.g. > 30 days). 
 
7. Patient is diagnosed with lumbar radicular pain. 
 
8. Patient has a known sensitivity to device materials. 
 
9. Patient is a prisoner. 
5 Subject Enrollment 
 
5.1 Treatment Assignment 
All subjects in Cohort 1 (cementless) will receive the Triathlon Tritanium Tibial Baseplate, 
Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial 
Insert.  All components in Cohort 1 (cementless) must be used in a cementless application.  

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All subjects in Cohort 2 (cemented) will receive the Triathlon Cemented Tibial Baseplate, 
Triathlon Cemented Patella, Triathlon CR or PS Cemented Femur and the Triathlon Tibial 
Insert.  All components in Cohort 2 (cemented) must be used in a cemented application.  
 
Patients will be enrolled until 356 subjects are implanted with the study device in Cohort 1 
(cementless) and 144 subjects are implanted with the control device in Cohort 2 (cemented). 
Patients will not count toward enrollment unless they receive all components and use them as 
indicated per the protocol for the specified study cohort.  
5.2 Randomization 
The study will enroll under a non-randomized concurrent control study design. Cohort 1 
(cementless) and Cohort 2 (cemented) will be enrolled contemporaneously. In the event the 
same center participates in both arms a consecutive series of patients will be enrolled into 
Cohort 1 (cementless) until the enrollment objective is met before commencement of enrollment 
of patients into Cohort 2 (cemented). 
 
6 Device Description 
6.1 Study Device 
The Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS 
Beaded Femur with PA and the Triathlon Tibial Inserts have been cleared for use in the United 
States; therefore, this study is considered a post-market assessment.  All cases in Cohort 1 
(cementless) must receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, 
Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. 
 
The Triathlon Tritanium Tibial Baseplate features the Tritanium advanced fixation technology 
that closely resembles the porous structure of trabecular bone to promote biologic fixation.  The 
Triathlon Tritanium Tibial Baseplate, the porous coating, solid keel, and solid pegs are built via 
Laser Rapid Manufacturing (LRM) with CP Titanium powder within a build envelope, and 
simultaneously bonded/melded onto a titanium alloy (Ti6Al4V ELI) substrate. CP Titanium 
powder is spread on top of the Ti6Al4V ELI substrate which is fixed to a piston inside the 
chamber.  The laser beam is controlled and focused by computer to the powder bed.  An argon 

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atmosphere is maintained within the chamber to prevent oxidation of the part during 
manufacturing. 
 
The Triathlon Tritanium Tibial Baseplate is available in eight sizes and is coupled with the 
Triathlon Tritanium Patella which is available in five asymmetric sizes and four symmetric sizes.  
These components are coupled with the existing Triathlon CR or PS beaded femoral 
components and the N2VAC or X3 Triathlon Tibial Inserts.  The combination of the Tritanium 
biologic fixation technology and the Triathlon Knee System design creates a two-tier high 
performance total knee system to provide surgeons with options for enhanced cementless knee 
fixation and joint stability which may meet the needs of today’s younger and more active TKA 
patients.  A description of the study device (Triathlon Tritanium Tibial Baseplate and Triathlon 
Tritanium Patella) follow.  Appendix I provides a listing of all protocol-specified components.  
The catalog numbers for the study device are listed in Table 1 and Table 2. 
 
Triathlon Tritanium Tibial Baseplate: 
The catalog numbers for the Triathlon Tritanium Tibial Baseplate permissible according to this 
study protocol will be in the following format, where ‘XXX’ varies by size: 
5536-B-XXX 
 
Triathlon Tritanium Patella: 
The catalog numbers for the Triathlon Tritanium Patella permissible according to this study 
protocol will be in the following format, where ‘XXX’ varies by size: 
5552-L-XXX (asymmetric) 
5556-L-XXX (symmetric)  
 
 
 
 
 
 
 
 
 
 

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Figure 1: Triathlon Tritanium Tibial Baseplate and Patella 
 
 
 
 
Additionally, only the following Stryker compatible ancillary devices are to be used for Cohort 1 
(cementless), according to this study protocol: 
 
o Triathlon CR Beaded Femur with PA 
o Triathlon PS Beaded Femur with PA 
o Triathlon Tibial Inserts 
 
The compatible Stryker components are listed in the surgical protocol. 
 
For reference, a description of the compatible femoral components and tibial inserts follow.    
Appendix I provides a listing of all protocol-specified components.  In the case of any uncertainty 
regarding device compatibility, the current version of the Triathlon Tritanium Knee System surgical 
protocol should be reviewed. 
 
Triathlon CR and PS beaded Femur: 
The catalog numbers for the Triathlon CR and PS beaded Femur permissible according to this 
study protocol will be in the following format, where ‘XXX’ varies by size: 
5516-F-XXX (PS femur) 
5517-F-XXX (CR femur) 
 
 

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Triathlon Tibial Inserts:  
The catalog numbers for the Triathlon Tibial Inserts permissible according to this study protocol 
will be in the following format, where ‘XXX’ varies by size: 
5530-P-XXX (CR insert, conventional polyethylene) 
5530-G-XXX (CR insert, X3) 
5531-P-XXX (CS insert, conventional polyethylene) 
5531-G-XXX (CS insert, X3) 
5532-P-XXX (PS insert, conventional polyethylene) 
5532-G-XXX (PS insert, X3) 
6.2 Control Device 
 
All study subjects that are part of Cohort 2 (cemented) concurrent control group will receive the 
Triathlon Cemented Tibial Baseplate, Triathlon Cemented Patella, Triathlon CR or PS 
Cemented Femoral Component, and Triathlon Tibial Inserts. The Triathlon Total Knee System 
components have been cleared in the United States under the following 510(k) numbers: 
Triathlon Cemented Femur (K042993), Tibial Inserts (K051146 and K050539), Triathlon Tibial 
Baseplate (K031729), Triathlon Patella (K040267). These components are intended for 
cemented application.  Appendix I provides a listing of all protocol-specified components. 
 
The Triathlon Cemented Tibial Baseplate is fabricated from cast cobalt-chromium-molybdenum 
alloy.  The Triathlon Cemented Tibial Baseplate is neutral in configuration, and is available in 
eight proportional sizes.  The undersurface of the tibial tray and the keel is grit blasted for 
interdigitation with polymethylacrylate (PMMA) bone cement.  The keel of the tibial tray is 
designed with normalizations for rotational stability and cement interdigitation.   The superior 
aspect of the tibial tray has a rim that contains tabs that mate with the outer periphery of the 
tibial insert, along with the locking wire used on the tibial insert.  This locking feature is designed 
to provide secure attachment of the tibial insert to the tray, and is designed to reduce 
micromotion of the tibial insert on the tray. 
 
The Triathlon Cemented Patella components are available in two styles, symmetric and 
asymmetric.  Both are fabricated from either N2VAC UHMWPE or X3 UHMWPE.  The 
symmetric design is available in six diameters (27 mm, 29 mm, 31 mm, 33 mm, 36 mm, and 39 
mm) and four thicknesses (8 mm, 9 mm, 10 mm, and 11 mm).  The symmetric design features a 
central cement recess, and three pegs on the bone interface surface.  The Triathlon Symmetric 

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Patellar component is intended to be implanted via a resurfacing or inset surgical technique.  
The asymmetric design features a flare in the lateral aspect of the component.  The asymmetric 
patellar component also has a central recess with three pegs for cement fixation. 
 
The Triathlon Cemented Femur is fabricated from cast cobalt-chromium-molybdenum alloy, and 
is intended for cemented application to replace the articulating surface of the distal femur.  It is 
available in right and left configurations, and eight proportional sizes (sizes 1 to 8) to 
accommodate differences in patient anatomy.  The interior surface of the component is grit-
blasted to increase the surface roughness – this is intended to promote interdigitation of the 
PMMA bone cement with the surface texture and the apposing bone. 
6.3 Device Retrieval Process 
 
Stryker Orthopaedics will retrieve the Triathlon Tritanium Tibial Baseplate and/or Patella and/or 
adjacent tissues for analysis to help characterize potential device-related complications.  In the 
event that the Triathlon Tritanium Tibial Baseplate and/or Patella are removed from a study 
subject, the procedure outlined in the Retrieved Implant Analysis Protocol (Appendix C) should 
be followed.  In addition: 
 
1. When revision of a study subject is scheduled, the study coordinator (SC) should contact 
the Clinical Study Manager (CSM) or other Stryker Clinical Research personnel 
assigned to the project, as soon as possible. 
2. Stryker Clinical Research will send a retrieval container to the SC. 
3. After the device is explanted, the SC or an identified Stryker field representative will 
retrieve the device and place it in the retrieval container, following the instructions in 
Appendix C. 
4. The SC, an identified field representative or Stryker Clinical Research will complete a 
Product Experience Report (PER). 
5. If not completed by Stryker Clinical Research, the PER should be faxed or emailed to 
Stryker Product Surveillance at 201-831-6775 or soprodexreports@stryker.com, as well 
as to Stryker Clinical Research at 201-831-6454 or to the Clinical Research email 
addresses listed on the Sponsor Contact Sheet. 
6. The PER should be attached to the retrieval container and sent to Product Surveillance.  
A de-identified operative report should be included, when available. 

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7. Stryker Clinical Research will follow up with Product Surveillance to obtain a PER 
number. 
8. A summary of results will be provided to the investigator upon his/her request. 
 
7 Evaluations 
7.1 Preoperative Visit 
During the preoperative visit, patients that are possible candidates for this study are screened to 
determine if they meet the inclusion/exclusion criteria.  If the patient is a candidate, the 
investigator proposes participation in the study to the patient, according to GCP guidelines.  
Patients must sign an IRB/EC approved Informed Patient Consent Form prior to participating in 
any study related activities.  Consent must be obtained within 4 months prior to surgery.  In the 
event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.   
 
Once the patient has been consented, preoperative data will be collected including: 
demographics and medical history, 2011 KSS, OKS, SF-12, AP, ML and Merchant radiographs 
for both Cohort 1 (cementless) and Cohort 2 (cemented).   
 
All preoperative data must be collected within 4 months prior to the scheduled date of surgery, 
with the exception of radiographs, acceptable within 1-year prior to the scheduled date of 
surgery.  All information collected preoperatively will be used to quantify the sample population 
and compare postoperative progress.  In the event a subject does not have surgery, Stryker 
should be contacted to discuss if/when the surgery will be rescheduled.  If the surgery is 
rescheduled more than 4 months from the date of preoperative data collection, the subject will 
need to be re-consented, as noted above. 
 
 
 

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7.2 Surgery 
 
Surgical details will be collected from the operative notes and at the time of surgery for both 
Cohort 1 (cementless) and Cohort 2 (cemented).  
7.3 6-week Visit 
During the 6-week visit (± 3 weeks), the following evaluations will be collected:  2011 KSS, 
OKS, SF-12, AP, ML and Merchant radiographs for both Cohort 1 (cementless) and Cohort 2 
(cemented). 
7.4 6-month Visit 
During the 6-month visit (- 14 - + 4 weeks), the following data will be collected:  2011 KSS, AP, 
ML and Merchant radiographs for both Cohort 1 (cementless) and Cohort 2 (cemented). 
7.5 Annual Follow-up Visits 
7.5.1 Cohort 1 (cementless) Annual Follow-up Visits 
 
Cohort 1 (cementless) will be followed to 10 years postoperatively according to the following 
schedule.  Clinical data will be collected via office visit by the investigator at the following annual 
postoperative intervals:  1-year, 2-year 5-year and 10-year. Tools for postoperative evaluation at 
each of these intervals will be the 2011 KSS, OKS, SF-12, AP, ML and Merchant radiographs.  
In the event that an in-person visit cannot be conducted and radiographs cannot be obtained, a 
Follow-up Questionnaire will be completed via mail, online completion (if available), or subject 
telephone interview with the subject by investigative site personnel.  
 
The Follow-up Questionnaire, OKS and SF-12 will also be collected at the 3-year, 4-year, 6-
year, 7-year, 8-year and 9-year intervals via mail, online completion (if available), or subject 
telephone interview with the subject by investigative site personnel.  The questionnaire is used 
to obtain information on satisfaction, pain, complications and any study device revisions to 
enable calculation of the Kaplan-Meier Survival Curves. 
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 2 months of 
the 1-year and 2-year anniversary dates.  For remaining annual time points, the window 
expands to ± 3 months of the 3-year anniversary date and ± 4 months of the 4-year through  

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10-year anniversary dates. 
 
7.5.2 Cohort 2 (cemented) Annual Follow-up Visits 
 
Cohort 2 (cemented) will be followed to 5 years postoperatively according to the following 
schedule.  Clinical data will be collected via office visit by the investigator at the following annual 
postoperative intervals:  1-year, 2-year and 5-year.  Tools for postoperative evaluation at each 
of these intervals will be the 2011 KSS, OKS, SF-12, AP, ML and Merchant radiographs.  In the 
event that an in-person visit cannot be conducted and radiographs cannot be obtained, a 
Follow-up Questionnaire will be completed via mail, online completion (if available), or subject 
telephone interview with the subject by investigative site personnel.  
 
The Follow-up Questionnaire, OKS and SF-12 will also be collected at the 3-year and 4-year 
intervals via mail, online completion (if available), or subject telephone interview with the subject 
by investigative site personnel. The questionnaire is used to obtain information on satisfaction, 
pain, complications and any study device revisions to enable calculation of the Kaplan-Meier 
Survival Curves. 
 
All clinical data, radiographs, and patient outcomes data must be collected within ± 2 months of 
the 1-year and 2-year anniversary dates.  For remaining annual time points, the window 
expands to ± 3 months of the 3-year anniversary date and ± 4 months of the 4-year and  
5-year anniversary dates. 
 
8 Adverse Events 
8.1 Reporting of Adverse Events 
The AE reporting requirements for this study are as follows: 
 
 
All AEs that are operative site related, regardless of seriousness or time of occurrence. 
 
 
All AEs that meet the definition of serious and occur within the perioperative period 
(intraoperative to hospital discharge)  
 

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On postoperative functional evaluations, investigators and SCs are prompted to question 
subjects as to whether they have seen a doctor for any reason, been hospitalized for any 
reason or have a current impediment to their function. 
 
Additionally, SCs are responsible for following up with the subjects regarding any questionable 
responses received on the Follow-up Questionnaire.  If it is determined upon this further 
investigation that a protocol-defined AE has occurred, the SC will be responsible for completing 
an AE eCRF, submitting the event to Stryker and reporting to the IRB/EC, as required. 
The following decision tree facilitates identification of AEs for which reporting is required under 
this study protocol: 
 
Figure 2: Adverse Event Decision Tree 
 
 
 
Start 
Site becomes 
aware of 
Adverse Event 
Is the event 
related to the 
operative 
site? 
Does the AE 
meet the 
criteria for 
Seriousness?
Do NOT report 
to Stryker 
Did the event 
occur within 
the 
perioperative 
period?
Report AE to 
Stryker via AE 
eCRF 
End 
Yes 
Yes 
Yes 
No 
No 
No 

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General Physical Examination Findings 
At screening for inclusion into the study, any clinically significant abnormality should be 
recorded as a preexisting condition and reported on the Demographics eCRF.  From the time of 
consent forward, any new clinically significant findings or abnormalities that meet the definition 
of a protocol defined AE must also be recorded and documented as an AE. 
Adverse Event Reporting Period 
The study period during which AEs must be reported is normally defined as the period from the 
initiation of any study procedures to the end of the study treatment follow-up.   The start of study 
procedures is considered to be the point of consent.  Any AEs which fit the protocol defined 
reportable events must be reported from the time of consent until study completion. 
 
At each contact with the subject the investigator must seek information on AEs by specific 
questioning and, as appropriate, by examination.  Information on protocol defined AEs should 
be recorded immediately in the source document and also in the appropriate AE module of the 
eCRF.  All clearly related signs, symptoms and abnormal diagnostic procedure results should 
be recorded in the source document and grouped under one diagnosis, as appropriate.  The 
clinical course of each event should be followed until resolution or until it is determined at the 
end of the study that the AE will not resolve.   
8.2 General Adverse Event Definitions 
Following is a list of general AE definitions.  For the purposes of this study, only SAEs occurring 
in the perioperative period, excluding elective procedures at any time, as well as all AEs related 
to the operative site should be reported.   
Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation subject, which changes the 
medical baseline of the subject.  An AE can be an unfavorable and unintended sign, symptom 
or disease, whether or not related to the study device (AEs may also be referred to as 
complications).  See Section 8.1, Reporting of Adverse Events, for the AE reporting 
requirements for this study. 
 

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Anticipated Adverse Event 
An anticipated AE is an AE, of which the nature, severity or degree of incidence is known and 
identified in applicable product labeling, published literature or the study protocol. The list of 
anticipated events is provided in Section 12, Risk/Benefit Assessment. 
 
Serious Adverse Event 
A SAE meets one or more of the following definitions: 
 
Resulted in in-patient hospitalization 
 
Resulted in prolonged existing hospitalization 
 
Resulted in persistent or significant disability/incapacity 
 
Resulted in permanent impairment of a body function or permanent damage to a body 
structure 
 
Necessitated medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body structure 
 
Was a life-threatening situation 
 
Resulted in patient death 
 
Adverse Device Effect 
An adverse device effect (ADE) is a negative change in the subject’s health that may have 
been caused by, or associated with, the use of the device. 
 
Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is any serious adverse effect on health, 
safety or any life-threatening problem or death caused by, or associated with, a device if that 
effect is a problem or death not previously identified in nature, severity or degree of incidence, 
or any other unanticipated serious problem associated with a device and related to the rights, 
safety or welfare of subjects. 
8.3 Study Sponsor Notification by Investigator 
Of reportable AEs, certain events must be submitted to Stryker within 24 hours for timely 
notification: 
 
 
 

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Adverse events that require time sensitive reporting: 
An AE should be reported to Stryker Clinical Research either by telephone/fax/email within 24 
hours of the site becoming aware of the event if any of the following apply: 
 
The AE is considered by the investigator to be device related or if the investigator 
is uncertain regarding the device related assessment; 
 
The AE required a reoperation of the study knee or a revision of any study knee 
components. 
 
An AE eCRF must be completed within 24 hours.  If a SAE occurs during the perioperative 
period, the de-identified source documentation must be uploaded to the appropriate location 
within Stryker’s Electronic Data Capture (EDC) system within 24 hours of the investigative 
center’s SAE awareness.  See Section 11, Data Management, for additional details of Stryker’s 
EDC system. These reports will be evaluated by Stryker to determine if a PER is required. 
 
It is recommended that all other reportable AEs are submitted through eCRF entry within 2 
weeks of becoming aware of the event. 
 
At the time of the initial report, the following information should be provided: 
 
 
Subject number 
 
A description of the event 
 
Date of onset 
 
Current status 
 
Whether study treatment was 
discontinued 
 
Investigator assessment of the 
association between the event and 
the study treatment 
 
8.3.1 Ethics Committee/Institutional Review Board Notification by 
Investigator 
Reports of AEs (including follow-up information) must be submitted to the EC or IRB 
according to their specific reporting requirements.  Copies of each report and 
documentation of EC/IRB notification and receipt must be kept with the investigator’s 
study files. 

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8.4 Recording of Adverse Events 
All protocol defined AEs occurring during the study period must be recorded; this includes 
events that occur between visit intervals.  The clinical course of each event should be followed 
until resolution or stabilization or until it is determined at the end of the study that the AE will not 
resolve. 
8.5 Medical Monitoring 
It is the responsibility of the investigator to oversee the safety of the study at his/her center.  
This safety monitoring will include careful assessment and appropriate reporting of AEs, as 
previously noted.  Stryker will conduct formal investigations via the Product Surveillance 
Department of those AEs which are submitted through our PER System.  
 
 
9 Statistical Plan 
 
9.1 Efficacy 
 
9.1.1 Primary Efficacy Parameters 
 
The primary efficacy parameter is the success rate at 2 years postoperative with the 
Triathlon Tritanium Tibial Baseplate for Cohort 1 (cementless), where success is defined 
as absence of tibial baseplate revision and/or removal for aseptic loosening at 2 years 
postoperative. 
9.1.2 Secondary Efficacy Parameters 
 
The secondary efficacy parameters include: 
 The all-cause survivor function of  the Triathlon Tritanium Tibial Baseplate by 
Kaplan-Meier method for Cohort 1 (cementless). 
 The  all-cause survivor function  of  the Triathlon Tritanium Patella by Kaplan-
Meier method for Cohort 1 (cementless). 
 The all-cause revision and/or removal rate of the Triathlon Tritanium Tibial 
Baseplate for Cohort 1 (cementless). 

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 
The all-cause revision and/or removal rate of the Triathlon Tritanium Patella 
for Cohort 1 (cementless). 
 
2011 KSS, SF-12 and OKS scores at 2 year for both cohorts. 
9.1.3 Primary Efficacy Analysis 
 
The primary hypothesis to be tested will be that the success rate at 2 years 
postoperative with the Triathlon Tritanium Tibial Baseplate for Cohort 1 (cementless) is 
not worse than 99% with a non-inferiority margin of 2%.   
 
That is, the following hypothesis will be tested: 
H0:  Pt <= 99% - 2%  HA:  Pt > 99%- 2%  
 
Here, Pt is the success rate at 2 years postoperative with the Triathlon Tritanium Tibial 
Baseplate for Cohort 1 (cementless).  
 
A 90% two-sided confidence interval will be computed for the success rate at 2 years. If 
the lower bound of the confidence interval is greater than 97%, then the non-inferiority 
hypothesis will be supported.  
 
9.1.4 Secondary Efficacy Analysis 
 
For Cohort 1 (cementless), the all-cause survivor function of the Triathlon Tritanium 
Tibial Baseplate will be produced by Kaplan-Meier method;   The all-cause survivor 
function of the Triathlon Tritanium Patella will be produced by Kaplan-Meier method;  
The all-cause revision and/or removal rate of the Triathlon Tritanium Tibial Baseplate will 
be calculated; The all-cause revision and/or removal rate of the Triathlon Tritanium 
Patella will be calculated.  The 2011 KSS, SF-12 and OKS scores will be compared 
between Cohort 1 (cementless) and Cohort 2 (cemented) at 2 years postoperative using 
applicable statistical methods. 
 
 
 

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9.2 Safety 
 
9.2.1 Safety Parameters 
 
Safety parameters include all protocol-defined AEs as well as revision and/or removal 
rates.  For details regarding protocol-defined AEs, see Section 8.1. 
 
9.2.2 Safety Analyses 
The frequency and percentage of all protocol-defined AEs will be tabulated.  For details 
regarding protocol-defined AEs, see Section 8.1. 
9.3 Missing Data 
 
Missing data in OKS will be imputed when calculating the OKS score using the method 
recommended by the new OKS scoring system.15  Missing data in 2011 KSS will be imputed 
when calculating KSS scores with the method recommended in the user manual of the 2011 
Knee Society knee scoring system.16  No other missing data will be imputed.  
 
9.4 Statistical Methodology 
 
9.4.1 Data Summary 
 
Descriptive statistics will be computed for all baseline conditions and demographic 
parameters.  That is, for continuous data, the N, mean, median, standard deviation, 
minimum and maximum will be computed.  For categorical data, the frequency will be 
computed.  The data will be presented by appropriate subgroups (e.g., center).  
 
A  Kaplan-Meier survivorship curve will be displayed for revision and/or removal of the 
Triathlon Tritanium Tibial Baseplate for aseptic loosening for cementless cohort.  
 
For the additional data collected according to Section 2.1.3, data will be summarized 
according to visits and cohorts.  For parameters represented by continuous variables 
(e.g., ROM), the summaries will consist of the N, mean, median, standard deviation, 
minimum, and maximum values.  For categorical variables (e.g., Gender from 

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Demographics), the frequency and percentage in each category will be presented.  A 
paired t-test will be performed to evaluate the change in clinical and patient outcomes, 
preoperative to 10 years for cases with the Triathlon Tritanium Tibial Baseplate in 
cementless cohort.  The 2011 KSS, OKS, and SF-12 will be compared and be presented 
with respect to improvement from preoperative to postoperative scores for both cohorts 
when applicable.  
 
For the Follow-up Questionnaire, frequency and percentage will be computed for each 
category according to visits and cohorts.  Applicable lists based on the Follow-up 
Questionnaire will be generated to capture AEs. 
  
For radiographic data, data will be presented according to visits and cohorts for available 
parameters.  Frequency and percentage will be computed for radiolucency according to 
visits.  Radiographs will be evaluated according to the guidelines of The Knee Society 
total knee arthroplasty roentgenigraphic evaluation and scoring system.13  
 
Documentation of statistical analyses will utilize SAS software version 9.1.3 or higher. 
9.4.2 Sample Size Justification 
 
With a reference value of 99% for the success rate at 2 years, under the assumptions of 
5% significance level (or 95% one-sided confidence interval), 95% power, 2% non-
inferiority margin, the sample size is 267.  After factoring a 15% lost to follow-up rate, the 
final sample size is 315 for the primary endpoint.  An enrollment objective of  356 cases 
in Cohort 1 (cementless) was selected to power the primary objective of this study. In 
addition, 144 cases will be enrolled in Cohort 2 (cemented) to serve as a concurrent 
control for one of  the secondary objectives.   
 
9.4.3 Interim Analyses 
 
No interim analysis is planned. 
 
 
 

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9.4.4 Analysis Population 
 
Per Protocol Population:  The study population for analysis will include all non-
censored subjects who receive the study devices and are available for efficacy 
evaluation.  For details regarding study devices, see Section 6.1 and 6.2.   
 
The primary and secondary efficacy analyses will be based on the per protocol 
population.   
 
Safety Population:  The safety population will include all non-censored subjects who 
received the study devices.  For details regarding study devices, see section 6.1 and 
6.2.  For details regarding protocol-defined AEs, see Section 8.1. 
 
The safety analysis will be based on the safety population. 
 
10 Study Procedures 
10.1  Subject Recruitment and Screening 
Patients are recruited at the study centers during preoperative visits through normal referral 
patterns.  All patients recruited for this study must have the capacity to give informed consent.  
Advertising for the study at each center will be at the discretion of the investigator.  All handouts, 
brochures, advertisements, etc. must be approved by the IRB/EC prior to the dissemination of 
any recruitment materials to potential subjects.  Study advertisement content may be found in 
Appendix D 
10.2   Patient Informed Consent and Guidelines 
 
All patients for this study are provided an Informed Patient Consent Form describing this study 
and providing sufficient information for them to make an informed decision about their 
participation.  The Informed Patient Consent Form must contain all elements required by the 
FDA under 21 CFR Part 50, in addition to any other elements required by state, local and 
institutional policies.  For international sites, the applicable country regulations are required.  
See Appendix E for a copy of the Model Informed Patient Consent.  This is submitted with the 
protocol for review and approval by the IRB/EC for the study.  All patients must provide written 
consent after having had adequate time to consider their participation in the study.  The formal 

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consent of a patient, using the IRB/EC approved Informed Patient Consent Form, must be 
obtained before that patient is submitted to any protocol related procedures that are not part of 
normal care.  Written documentation of consent must be provided on the Informed Patient 
Consent Form’s signature page in addition to a note in the patient medical records indicating the 
date that consent was obtained.  The investigator-designated research professional obtaining 
the consent must also sign this Informed Patient Consent Form.  The patient or his/her legal 
representative should receive a signed copy of the Informed Patient Consent Form, according to 
GCP guidelines.   
 
The procedure for obtaining informed consent is outlined below: 
 
Use a current IRB/EC approved copy of the Informed Patient Consent Form. 
 
Review thoroughly with the patient before having them sign. 
 
After the patient has consented to the procedures, ensure he/she signs and dates the 
Informed Patient Consent Form. 
 
The person obtaining consent also signs and dates the signature page. 
 
Provide a copy of the Informed Patient Consent Form to the patient. 
 
If required, provide the hospital with a copy of the signed Informed Patient Consent 
Form. 
 
Maintain the signed original in the patient’s study chart. 
10.3  Early Withdrawal of Subjects 
 
When and How to Withdraw Subjects 
In the event that the subject is discontinued by the investigative center prior to the final study 
evaluation, the subject is notified by the center that he/she is no longer in the study and a Study 
Termination eCRF will be completed.   
 
The following is a list of reasons for which subjects may be withdrawn and the date of 
termination that should be used on the Study Termination eCRF in each situation.  This list is 
not all inclusive: 
 
 
 
 
 

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Termination Reason 
 
 
 
Date of Termination 
Death 
 
 
 
 
 
Date of death 
Investigative center termination  
 
Date of study close-out visit 
Lost to follow-up  
 
 
 
Date Stryker termination approval given 
Voluntary withdrawal 
 
 
 
Date subject notified center of withdrawal 
Revision/removal of study device  
 
Date of revision/removal procedure 
Study device not implanted 
 
 
Date of surgery 
Surgery not performed 
 
 
 
Date Stryker termination approval given 
 
 
At the time of study surgery it is required that the following components are implanted for each 
treatment group: 
 
o Cohort 1 (cementless) 
o Triathlon Tritanium Tibial Baseplate 
o Triathlon Tritanium Patella 
o Triathlon CR or PS Beaded Femur with PA 
o Triathlon Tibial Insert  
 
o Cohort 2 (cemented) 
o Triathlon Cemented Tibial Baseplate 
o Triathlon Cemented Patella 
o Triathlon CR or PS Cemented Femur  
o Triathlon Tibial Insert 
 
Revision or removal of the Triathlon Tritanium Tibial Baseplate for aseptic loosening constitutes 
a failure for purposes of the primary endpoint.  Revision or removal of the Triathlon Tritanium 
Tibial Baseplate for any reason requires study termination for the subject. 
 
If revision of the Triathlon Tritanium Patella, Triathlon Beaded Femur or Triathlon Tibial Insert 
component is required during the study, the event does not constitute a failure or study 
termination for Cohort 1 (cementless).  If revision of the Triathlon Cemented Patella, Triathlon 
Cemented Femur or Triathlon Tibial Insert component is required during the study, the event 
does not constitute a failure or study termination for Cohort 2 (cemented). 
 

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If the subject fails to return for his/her follow-up appointments, every effort should be made to 
contact the subject to assess his/her health status.  If, after attempting to contact the subject 
through three documented phone calls and a certified letter, and the subject still does not 
respond, he/she will be considered lost to follow-up.  A Study Termination eCRF will be 
completed only after notifying Stryker of the subject’s status and being given approval to 
terminate.   
 
In the event a subject does not have surgery, Stryker should be contacted to discuss if/when the 
surgery will be rescheduled.  If the surgery is rescheduled more than 4 months from the date of 
preoperative data collection, the subject will need to be re-consented, all preoperative data will 
need to be re-collected and all original preoperative data will need to be removed from the 
database.  If the surgery is not to be rescheduled or if the subject is no longer considered an 
appropriate study candidate, a Study Termination eCRF may be completed only after notifying 
Stryker of the subject’s status and being given approval to terminate. 
 
When a subject completes the study according to protocol, including the final study evaluation, a 
Study Termination eCRF will be completed. 
 
11 Data Management 
11.1  Database 
 
Data will be collected at each center and entered into Stryker’s EDC system.  The system can 
be accessed remotely by each investigative center and the data entered will be managed by 
Stryker.  Subject data will be processed and monitored according to the protocol schedule by 
Stryker or Stryker representatives.  Draft specifications to support eCRFs are provided in 
Appendix F 
11.2  Confidentiality 
 
This study complies with the 2002 HIPAA privacy rule.  As such, Stryker only collects that 
information which is necessary to support the objectives of the clinical study.  Stryker takes 
precautions to ensure that data received is as de-identified as possible.  In the case that some 
identified information is received, Stryker ensures that any identifying information is not 
reported.  Study subjects will authorize Stryker to use their health information in support of the 

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clinical study during the informed consent process.  Should a subject choose to withdraw 
authorization, Stryker may use data collected prior to the withdrawal of authorization in order to 
maintain data integrity.  
11.3  Source Documents 
 
Source data include all information, original records of clinical findings, observations or other 
activities in a clinical study necessary for the reconstruction and evaluation of the study.  Source 
data are contained in source documents.  Examples of these original documents and data 
records include:  hospital records, clinical and office charts, study worksheets, laboratory notes, 
memoranda, subject questionnaires, pharmacy dispensing records, recorded data from 
automated instruments, radiographs, subject files, and records kept at the pharmacy, at the 
laboratories and at medico-technical departments involved in the clinical study. 
All data points collected during preoperative and follow-up visits must be documented in the 
subject’s chart.  This includes range of motion values, pain and function as well as AEs and 
additional comments.  The informed consent process should also be documented in the patient 
chart.  Monitors, defined further in Section 13, compare the eCRFs against source documents 
for accuracy.  The monitors seek to draw a reference between each data point on the eCRF and 
the subject’s chart.  Thus, one cannot derive pain, ROM or function based on a chart note that 
reads “Patient doing well.”  Every effort should be made to ensure complete source 
documentation.  
Centers are required to create a source documentation plan including any applicable source 
documentation worksheets prior to enrollment. 
11.4  Electronic Case Report Forms 
 
The study eCRFs are the primary data collection instrument for the study.  All data requested on 
the eCRF must be documented.  All missing data must be explained.  It is recommended that 
eCRFs be completed and electronically signed by the investigator within 2 weeks of the 
evaluation date. 
 
 

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11.5  Data Clarification Requests 
 
If errors or omissions are noted by Stryker upon review of the data entered into the eCRFS, a 
data clarification request (DCR) is sent to the center within the EDC system.  Queries should be 
answered in a clear and comprehensible manner.  If the clarification requires a change to study 
data, the EDC system updates the eCRF automatically with the data captured in the DCR 
response.  Conversely, a change to the data that brings it within the expected range of values 
will automatically close the DCR.  The investigative center is required to reapply their electronic 
signature to the modified eCRF.  Modified eCRFs need not be printed and included in 
conjunction to answered DCRs. 
11.6  Protocol Deviations 
 
Any deviation from this protocol is recorded in Stryker’s Clinical Trial Management System and 
must be reported to the EC/IRB by the investigational site according to their reporting 
procedures.  Protocol Deviations for this study may include the following; this list may not be all-
inclusive:  
 
 
Informed consent deviations, including but not limited to: 
o Study procedures performed prior to informed consent 
o Incorrect informed consent version used 
 
Patient enrolled does not meet the inclusion/exclusion criteria 
 
Protocol specified study component(s) not implanted 
 
Visit deviations, including: 
o Unavailable primary endpoint 
 
If the center anticipates a possible protocol deviation, the investigator or SC should contact 
Stryker for guidance. 
11.7  Records Retention 
 
It is the investigator’s responsibility to retain study essential documents for 2 years after the date 
of the final report, or in the case of non-compliance, 2 years after the date of investigative center 
termination.  These documents should be retained for a longer period if required by an 
agreement with Stryker. 
 

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12  Risk/Benefit Assessment 
12.1  Risk Category 
 
There are no additional risks associated with participating in this study over and above that of 
the primary TKA procedure.  
12.2  Potential Risk 
 
The study involves the routine assessment of a primary TKA procedure.  The study device has 
been cleared for use by the FDA and will be used according to its labeling, included in Appendix 
G.  Assessment involves questionnaires, patient and physician assessments as well as routine 
radiographs.  The information collected will be kept confidential and will comply with the HIPAA 
privacy rule. 
 
While the expected life of TKA components is difficult to estimate, it is finite.  These components 
are made of foreign materials, which are placed within the body for the potential restoration of 
mobility or reduction of pain.  However, due to the many biological, mechanical and 
physiochemical factors which affect these devices but cannot be evaluated in vivo, the 
components cannot be expected to indefinitely withstand the activity level and loads of normal 
healthy bone. 
 
Adverse effects associated with primary TKA include the following: 
 
Serious complications may be associated with any total joint replacement surgery.  These 
complications include, but are not limited to:  infection; genitourinary disorders; gastrointestinal 
disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including 
emboli; myocardial infarction or death. 
 
With all implanted devices, asymptomatic, localized progressive bone resorption (osteolysis) 
may occur around the prosthetic components as a consequence of foreign-body reaction to the 
particulate matter of metal, and/or UHMWPE.  Particulate is generated by interaction between 
components as well as adhesion, abrasion and fatigue.  Secondarily, particulates can be 
generated by third body wear.  Osteolysis can lead to future complications, including loosening, 
necessitating the removal and replacement of prosthetic components. 

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Early and late loosening of total knee components can occur.  Early biomechanical loosening 
may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or 
trauma.  Late loosening may result from trauma, infection, biological complications including 
osteolysis or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 
 
Peripheral neuropathies, circulatory compromise and heterotopic bone formation may occur. 
 
Intraoperative fissure, fracture, or perforation of the femur, patella or tibia can occur due to 
impaction of the component into the prepared femur, patella or tibia.  Postoperative femoral, 
patellar or tibial fracture can occur due to trauma, the presence of defects or poor bone stock. 
 
Metal sensitivity reactions have been reported following joint replacement. 
 
AEs may necessitate reoperation, revision, arthrodesis of the involved joint or amputation of the 
limb. 
12.3  Expected Complications  
Complications associated with TKA procedures, such as those performed with the study device, 
have been reported.  These complications include but are not limited to:  infection, 
genitourinary, gastrointestinal disorders, vascular disorders, bronchopulmonary disorder, 
myocardial infarction, injury to the knee’s neurovascular structures, loosening of the 
components, osteolysis, heterotopic bone formation, deep vein thrombosis, pulmonary 
embolism, metal sensitivity reactions, intraoperative or postoperative fracture of the femur, 
patella or tibia, and the need for re-operation, revision, arthrodesis of the involved joint, 
amputation of the limb and death.  The safety analysis will include tabulation of AE rates as well 
as revision/removal rates.   
12.4  Protection Against Risks 
 
Subjects are treated in the best medical judgment of the investigator, regardless of the study 
protocol.  If an investigator must deviate from the written protocol to protect the health or well 
being of the subject, this deviation is promptly reported to both the EC/IRB and Stryker.   

Triathlon Tritanium Knee Outcomes Study 
 
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Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 2 
 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
12.5  Potential Benefits to the Subject 
 
There is no guarantee that subjects personally benefit from inclusion in this study.  Subjects 
may undergo more thorough screening and follow-up than non-study patients and may benefit 
from this increased surveillance.  This study seeks to provide clinicians information about this 
device by comparing it to published results for other similar devices.  Information gathered in 
this study may benefit others undergoing this procedure in the future. 
 
13 Study Monitoring, Auditing, and Inspecting 
13.1  Study Monitoring Plan 
 
Monitors are persons employed by sponsors to review the conduct of clinical studies to assure 
that the clinical investigators abide by their obligations to conduct clinical studies properly.  
Proper monitoring ensures adequate protection of the rights of human subjects, the safety of 
subjects involved in a clinical investigation and the quality and integrity of data submitted as a 
result of the investigation. 
 
This study is monitored at least once per year, with additional monitoring as necessary. The 
investigator allocates adequate time for such monitoring activities.  The investigator also 
ensures that the monitor or other compliance or quality assurance reviewer is given access to 
all study-related documents and study-related facilities, as applicable, and has adequate space 
to conduct the monitoring visit, when applicable.  The monitor reviews all source documents and 
compares them to the data contained in the eCRFs, in addition to performing a periodic review 
of regulatory documents such as EC/IRB approvals.  The monitors need the following: 
 
An area where they can review study data, when monitoring is conducted on site 
 
Access to eCRF data for all cases 
 
Access to source documentation 
 
Regulatory documents 
 
Time to discuss findings with the SC and the investigator  
 
 
 

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
13.2  Auditing and Inspecting 
 
A quality assurance audit is a form of review that provides additional confidence to the sponsor 
concerning the validity and accuracy of clinical study data that must be submitted to the FDA or 
for publication.  The purpose of investigator audits is to ensure that the investigator has 
maintained all study information according to the sponsor’s protocol and standard operating 
procedures and in compliance with FDA regulations. 
 
The investigator permits study-related monitoring, audits, and inspections by the EC/IRB, 
Stryker and/or government regulatory bodies of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data).  The investigator 
ensures the capability for inspections of applicable study-related facilities. 
 
14 Ethical Considerations 
 
This study is to be conducted according to United States standards of GCPs and applicable 
government regulations including 21 CFR Parts 50 and 56 as well as 45 CFR Parts 160 and 
164. 
 
This protocol and any amendments are to be submitted to a properly constituted independent 
EC/IRB for formal approval of the study conduct.  The decision of the EC/IRB concerning the 
conduct of the study is made in writing to the investigator and a copy of this decision is provided 
to Stryker before commencement of this study.  The investigator may be asked to provide a list 
of EC/IRB members and their affiliates to Stryker, if available. 
 
All patients considered for this study are provided an Informed Patient Consent Form describing 
this study and providing sufficient information for patients to make an informed decision about 
their participation.  This Informed Patient Consent Form must be modified to contain center 
specific information and submitted with the protocol for review and approval by the EC/IRB for 
the study.  The formal consent of a patient, using the EC/IRB approved Informed Patient 
Consent Form, must be obtained before that patient is submitted to any study procedure.  This 
Informed Patient Consent Form must be signed by the patient or legally acceptable surrogate 
and the investigator-designated research professional obtaining the consent.  

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Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 2 
 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
 
15 Study Finances 
15.1  Funding Source 
 
This study is financed by Stryker Orthopaedics. 
15.2  Conflict of Interest 
 
Any investigator who has a conflict of interest with this study (e.g. patent ownership, royalties or 
financial gain greater than the maximum allowable by their institution) must have the conflict 
reviewed by their EC/IRB or a properly constituted Conflict of Interest Committee with a 
Committee-sanctioned conflict management plan that has been reviewed and approved by 
Stryker prior to participation in this study.   
15.3  Subject Stipends or Payments 
 
Subject attrition can occur for a variety of reasons, including a subject’s loss of health insurance 
coverage.  In a case where a patient has lost health insurance coverage and no other coverage 
is available, Stryker may, on a case-by-case basis, reimburse investigators for office visits and 
radiographic charges for subjects involved in this study in order to facilitate data retrieval.  The 
physician or the office staff should contact the CSM prior to scheduling the subject to discuss 
this possibility and receive pre-approval from Stryker.  After receipt of the completed data forms, 
the physician must submit either evidence of coverage denial (e.g. explanation of benefits) or a 
letter explaining that the subject does not have insurance.  Other visits, procedures and 
assessments done other than those specified in the protocol are not reimbursed.  
Reimbursement may be provided under the following conditions: 
 
Study subjects lose insurance coverage after enrollment into the study 
 
An insurance carrier refuses to pay for a follow-up visit and/or radiographs     
 
An insurance carrier refuses to provide a subject referral to see the investigator for 
follow-up  
 
 
 

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Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 2 
 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
Under extreme circumstances, and with prior approval, Stryker may reimburse a subject for the 
cost of transportation to and from the investigator’s office for a protocol-required office visit. 
 
This policy is the same for all participating study subjects and does not bias against any 
particular subject or study cohort.  
16 Publication Plan 
 
It is anticipated that publication of the multi-center study results will be compiled and submitted 
to a peer-reviewed journal at the time the study cohort reaches 2, 5 and 10 years of follow-up.  
Early results with regard to surgical information, postoperative biomechanics and early 
radiographic assessments may be published prior to the 2-year time point.  Additional 
publication proposals may also be made by investigators at any time and will be considered. 
 
This study will utilize the guidelines for authorship published by the International Committee of 
Medical Journal Editors (ICMJE).  This guidance can be referenced at www.icmje.org. 
 
Publications will be facilitated by the Chair and the primary investigator (PI) of the study.  Both 
individuals will be chosen by Stryker. 
 
The PI is solely focused on the multi-center publications and progress towards those 
publications, including recurring updates to centers, center motivation as well as authorship.  If 
the PI does not produce a draft of a publication within 90 days of receiving the results data, 
Stryker will delegate the responsibility to other investigators in the study at its discretion. 
 
The Chair reviews all additional publications proposed by participating investigators based upon 
the study results prior to study completion, on an ongoing basis.  This review includes whether 
or not a proposal will be pursued, as well as imposition of guidelines as to publication 
completion and criteria. 
 
 
 
 
 

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Stryker Orthopaedics Clinical Study Protocol 
 
 
Version 2 
 
CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
The following summarizes the possible roles of these parallel positions: 
Chair 
PI 
Contributes to study design 
Contributes to study design 
Assists with study questions requiring expert 
clinical opinion 
Assists with study questions requiring expert 
clinical opinion 
Assists with identification of investigators 
Assists with identification of investigators and 
maintains performance 
Reviews additional publication proposals 
submitted by investigators 
Updates investigators on progress towards 
multi-center results 
Contributing author, if ICMJE guidelines met 
Primary author, multi-center publication of 
primary endpoint data 
 
At the completion of the study, each participating study investigator shall have independent 
publication privileges for his/her own center’s results.  These manuscripts and abstracts will be 
delayed until after the 2, 5 and 10-year multi-center publications are submitted.  Although 
Stryker will not be involved in coordinating these independent manuscripts, all publications of 
the data shall be submitted to Stryker for review prior to submission for publication.  Stryker 
shall not edit or otherwise influence the publications other than to ensure that confidential 
information is not disclosed, that no off-label use of Stryker devices is promoted and that the 
data is accurately represented.  Any publications resulting from this study must be submitted to 
Stryker for review at least 60 days prior to submission of publication. 
 
 

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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
 
17 References 
1. 
 
                                                 
1 Brown, EC, Scuderi, GR, Clarke, HD. The painful total knee arthroplasty:  diagnosis and 
management. Orthopedics. 2006; February 29(2). 
2 Stryker Literature Number LTKDR 
3 Hollister AM, Jatana S, Singh AK, Sullivan WW, Lupichuk AG. The axes of rotation of the 
knee. Orthopaedic Laboratory, Harbor-UCLA Medical Center, Torrance. Clin Orthop. 1993 
May;(290):259-68. 
 
4 Freeman MAR, Pinskerova V, Hill PF, Vedi V,Williams A, Iwaki H, Kadoya Y, Kobayashi A, 
Nakagawa S, Sakamoto H, Todo S, Yamano Y, Brandsson S, Karrholm J. Tibiofemoral 
movement – Studies in the cadaveric and living knee using MRI, dissection and RSA; British 
Editorial Society of Bone and Joint Surgery, 2001. 
 
5 Churchill DL, Incavo SJ, Johnson CC, Beynnon BD. The transepicondylar axis approximates 
the optimal flexion axis of the knee. Clin Orthop. 1998 Nov;(356):111-8. 
 
6 Meneghini RM, Hanssen AD.  Cementless fixation in total knee arthroplasty: past, present, and 
future.  J Knee Surg. 2008 Oct;21(4):307-14. Review.  
 
7 Brown, TE, Harper, BL, Bjorgul, K. Comparison of cemented and Uncemented Fixation in TKA, 
Orthopaedics, May 2013 vol 35 number 5 pp380-387 
 
8 Ricci J. L., Kauffman J., Jaffe W., et al. (1997) Comparison of Osseointegration and Bone 
Adhesion 
9 Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. (2004). Bone response to a novel highly 
porous surface in a canine implantable chamber.  J Biomed Mater Res B Appl Biomater. 71(2), 
387-91. 
 
10 Bobyn JD, Stackpool GJ, Hacking SA, Tanzer M, Krygier JJ. Characteristics of bone ingrowth 
and interface mechanics of a new porous tantalum biomaterial.  Journal of Bone and Joint 
Surgery. 1999; 81-B(5): 907-914. 
11 Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH.  The new Knee Society Knee 
Scoring system. Clinical Orthopaedics and Related Research.   2012; 470: 3-19. 
12 Noble PC, Scuderi GR, Brekke AC, Sikorskii A, Benjamin JB, Lonner JH, Chadha P, 
Daylamani DA, Scott WN, Bourne RB.  Development of a Knee Society Knee Scoring system. 
Clinical Orthopaedics and Related Research.  2012; 470: 20-32. 
 
13 Ewald, FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring 
system. Clinical Orthopaedics and Related Research.  1989; 248, 9-12. 
14 Ibid. 
15 OKS D.W. Murray, R. Fitzpatrick, K. Rogers et al., “The use of the Oxford hip and knee 
scores,” Journal of Bone and Joint Surgery B, vol. 89, no. 8, pp. 1010–1014, 2007 
 

Triathlon Tritanium Knee Outcomes Study 
 
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CONFIDENTIAL 
This material is the property of Stryker Orthopaedics.  Do not disclose or use except as authorized in writing by Stryker. 
                                                                                                                                                             
 
16 The Knee Society. The 2011 Knee Society Knee Scoring System: Licenced User Manual. 
2012. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix A 
 
510(k) Clearance Letters 

Triathlon
TM Cruciate Retaining (CR) Total Knee System
510(k) Premarket Notification 
Confidential
MAY - 5 2004 
510(k) Summary
Submission Information
Name and Address of Sponsor: 
Howmedica Osteonics Corp.
DBA (doing business as) Stryker Orthopaedics
325 Corporate Drive
Mahwah, New Jersey 07430
For Information contact: 
Margaret F. Crowe
Regulatory Affairs Consultant
Howmedica Osteonics Corp.
(DBA Stryker Orthopaedics)
325 Corporate Drive
Mahwah, New Jersey 07430
Device Identification
Proprietary Name: 
Triathlon
TM Cruciate Retaining (CR) Total Knee
System
Common Name: 
Cruciate Retaining Total Knee Replacement
Classification Name and Reference: 
Knee Joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrained
Cemented Prosthesis
21 CFR §888.3560
Proposed Regulatory Class: 
Class II
Device Product Code: 
OR (87) JWH
Prosthesis, Knee Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/ Polymer
The Triathlon
TM CR Total Knee System consists of a femoral component, tibial insert, and
all-polyethylene patellar components that are intended to be used with the previously
cleared TriathlonTM Primary Cemented Tibial Tray in primary or revision total knee
arthroplasty. The TriathlonTM All Polyethylene Patellar components are intended to be
used with the femoral components of the previously released Duracon® Total Knee
System, as well as the previously released Triathlon TM PS Femoral component in

Triathlon
TM Cruciate Retaining (CR) Total Knee System
510(k) Premarket Notification 
Confidential
situations where replacement of the articular surface of the patella is required. The
TriathlonTM CR Total Knee System is intended to accommodate the posterior cruciate
ligament (PCL) if it is present. Specific indications and contraindications are listed
below:
Indications:
* Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or,
rheumatoid arthritis
* Post-traumatic loss of knee joint configuration and function.
·
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be
returned to adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture management techniques.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site
·
Any mental or neuromuscular disorder which would create an unacceptable risk of
prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Bone stock compromised by disease, infection or prior implantation that cannot provide
adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
·
Severe instability of the knee joint secondary to the absence of collateral ligament integrity
and function.
·
Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to
failure of the fixation of the device or to failure of the device itself
Device Description
3

~\OHo267 
(fj 
3oA'5)
Triathlon
TM Cruciate Retaining (CR) Total Knee System
510(k) Premarket Notification 
Confidential
The Triathlon
T M Cruciate Retaining (CR) Total Knee System consists of three primary
components: Triathlon
T
M Cruciate Retaining (CR) Femoral Component, Triathlon
TM
Cruciate Retaining (CR) Tibial Insert, and TriathlonTM Patellar components (available in
two styles - symmetric and asymmetric). 
These components are intended to be used
with the previously cleared TriathlonTM Primary Cemented Tibial Tray in primary or
revision total knee arthroplasty. The Triathlon TM Patellar components are intended to be
used with both the Triathlon TM CR Femoral component, the previously cleared
TriathlonTM PS Femoral component, or the femoral components of the Duracon® Total
Knee System. Duracon® patellar components may be used with both the TriathlonTM PS
and TriathlonTM CR femoral components. The use of a patellar component is optional.
The TriathlonTM CR components are described below:
The Triathlon
TM Total Knee Cruciate Retaining (CR) Femoral Component is fabricated
from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application
to replace the articulating surface of the distal femur. This cruciate retaining femoral
component is utilized when total knee replacement is indicated, and accommodates the
posterior cruciate ligament if it is present.
The Triathlon TM Total Knee Cruciate Retaining (CR) Femoral Component is available in
right and left configurations, and eight proportional sizes (sizes 1 to 8) to accommodate
differences in patient anatomy. The interior surface of the component is grit-blasted to
increase surface roughness - this is intended to promote interdigitation of the
polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing
bone. This femoral component features cast-in pegs to help in femoral component
placement, and to provide rotational stability.
The Triathlon
TM Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is
available in seven proportional sizes (sizes 2 to 8) and varying thicknesses (9mm, 1 1mm,
13mm, 16mm, and 19mm). The insert is fabricated from ultra high molecular weight
polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial insert on
the bearing surface is 6mm. The tibial insert is designed to accommodate the posterior
4

~DR 0267 
(e9 
~ J 
;
Triathlon
T M Cruciate Retaining (CR) Total Knee System
510(k) Premarket Notification 
Confidential
cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial
insert to accommodate the patellar tendon and patellar fat pad.
The Triathlon
TM CR Tibial Insert incorporates a locking wire feature on the anterior aspect
of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages
under tabs on the anterior rim of the Triathlon
TM Primary Tibial Baseplate. This wire-tab
locking mechanism secures the insert into the baseplate. This insert-baseplate locking
mechanism is identical to the locking mechanism utilized on the TriathlonTM PS Total
Knee System.
TriathlonTM Patellar components are available in two styles: symmetric and asymmetric.
Both are fabricated from ultra high molecular weight polyethylene. The symmetric
design is available in six diameters (27mm, 29mm, 3 1mm, 33mm, 36mm, and 39mm)
and four thicknesses (8mm, 9mm, 10mm, and 11 mm). The symmetric design features a
central cement recess, and three pegs on the bone interface surface. The TriathlonTM
Symmetric patellar component is intended to be implanted via a resurfacing or inset
surgical technique. The asymmetric design is available in five superior/inferior
dimensions (29rmm, 32mm, 35mm, 38mm, and 40mm) and three thicknesses (9mm,
i0mm, and 11 mm). The asymmetric design features a flare on the lateral aspect of the
component. The asymmetric patellar component also has a central recess with three pegs
for cement fixation. The Triathlon TM Asymmetric patellar component is intended to be
implanted using a resurfacing surgical technique.
Equivalent products include:
1. TriathlonTM PS Total Knee System
2. Duracon® CR Femoral Component
3. Scorpio® CR Femoral Component
4. Duracon ® A/P Lipped Tibial Insert
5. Duracon® Symmetric Patellar Component
6. Duracon® Asymmetric Patellar Component
7. Kinemax® All Polyethylene Patella
5

Triathlon 
TM Cruciate Retaining (CR) Tota Knee Sv-tem
510(k) Premarket Notification 
Confidential
Testing was presented to support a claim of substantial equivalence to the predicate
devices.
6

DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
MAY - 5 2004 
Rockville MD 20850
Ms. Margaret F. Crowe
Regulatory Affairs Consultant
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Re: K040267
Trade/Device Name: TriathlonT M Cruciate Retaining (CR) Total Knee System
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained
cemented prosthesis
Regulatory Class: II
Product Code: JWH
Dated: February 4, 2004
Received: February 5, 2004
Dear Ms. Crowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
may be subject to such additional controls. Existing major regulations affecting your device can
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ms. Margaret F. Crowe
This letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device
to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled,
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure

Indications forv s
1 '-(Division Sign-Off)
510(k) Number (if known): K040267
Division of General, Restorative,
Device Name: TriathlonrM CR Total Knee System 
and Neurological Devices
Indications For Use:
510(k) Number 
0 QqO&:]-
The Triatilon*" CR Total Knee System consists of a femoral component, tibial insert, and all-
polyethylene patellar components that are intended to be used with the previously cleared
Triathlon
Tm Primary Cemented Ti.bial Tray in primary or revision total knee arthroplasty. The
TriathlonTM All Polyethylene Patellar components are intended to be used with the femoral
components of the previously released Duracon® Total Knee System, as well as the previously
released. Triathlon
Tm PS Femoral component in situations where replacement of the articular
surface of the patella is required. The TriathlonTM CR Total. Knee System is intended to
accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and
contraindications are listed below:
Indications:
* Painful, disabling joint disease of the knce resulting from: noninfiamnmatory degenerativejoint disease
(including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheunatoid. arthritis
Post-traumatic loss of kneejoint configuration and function.
* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can bc returned to
adequate fuiction and stability.
Revision of previous unsuccessful knee replacement or other procedure.
.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture
management techniques.
Contraindications
·
Any active or suspected latent infection in or about the knee joint.
• Distant foci of infectionv 
which may cause hematogenous spread to the implant site
• Any mental or neuromuscular disorder which would create an unacceptable risk ofprosthesis
instability, prosthesis fixation failure, or complications in postoperative care.
B 
.one stock compromised by disease, infection or prior implantation that cannot provide adequate
support and/or fixation to the prosthesis.
o Skeletal immaturity.
, Severe instability of ftle knee joint secondary to the absence of collateral ligament integrity and
function.
Obesity. An ovenveight or obese patient can produce loads on the prosthesis that can lead to failure of
the fixation of the device or to failure of the device itself.
Prescription Use 
X 
AND/OR 
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) 
(21 CFR 807 Subpart C)
f 
/jI 
,

mOLfO2J37 
( 
~Y
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pagejof _
I vjision Sign-Oft)
Division of General, Restorative,
and NeurologIca De-vices
S~~h~k) 
Number6-

Triathlon 
T M Posteriorly Stabilized (PS Femoral Component (5515)
510(k) Premarket Notification 
Confidential
JAN 1 27005
510(k) Summary
Submission Information
Name and Address of Sponsor: 
Howmedica Osteonics Corp.
325 Commerce Court
Mahwah, NJ 07430
For Information contact: 
Denise Duchene
Sr. Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Commerce Court
Mahwah, NJ 07430
Device Identification
Proprietary Name: 
TriathlonTM Posteriorly Stabilized (PS) Femoral
Component (5515)
Common Name: 
Posteriorly Stabilized Knee Femoral Component
Classification Name and Reference: 
Knee Joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrained
Cemented Prosthesis
21 CFR §888.3560
Proposed Regulatory Class: 
Class II
Device Product Code: 
OR(87) JWTH
Prosthesis, Knee Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/ Polymer
It is the intention of Howmedica Osteonics Corp. to modify the design of the TriathlonTM
Posteriorly Stabilized (PS) Femoral Component (previously released under K031729) to
improve component manufacturability.
The design change for the Triathlon
TM PS Femoral Component involves a removal of
material from the superior, posterior region of the cam (or box) section of the femoral
2

TriathlonTM Posteriorly Stabilized (PS Femoral 
Component (5515)
5 10(k) Premarket Notification 
Confidential
component adjacent to the posterior femoral condyles. This material is being removed to
improve manufacturability of the component. The articular surface designs of the
component (both patello-femoral and tibio-femoral) are unchanged by this modification.
The intended use of the TriathlonTM PS Femoral Component is identical to that of the
predicate: it is intended to be used with TriathlonTM PS tibial inserts, TriathlonTM
Primary Cemented Tibial Tray, and TriathlonTM and/or Duracon® patellar components in
primary or revision cemented total knee arthroplasty. Specific indications and
contraindications are listed below:
Indications:
* Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or,
rheumatoid arthritis
* Post-traumatic loss of knee joint configuration and function.
* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be
returned to adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture management techniques.
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased
constraint.
* Absent or non-functioning posterior cruciate ligament.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site
·
Any mental or neuromuscular disorder which would create an unacceptable risk of
prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
3

2j3
Triathlon Posteriorly Stabilized (PS Femoral Component (5515)
510(k) Premarket Notification 
Confidential
* Bone stock compromised by disease, infection or prior implantation that cannot provide
adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity
and function.
* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to
failure of the fixation of the device or to failure of the device itself
Device Description
The modified TriathlonTM PS Femoral Component (catalog number 5515) is identical to
the previously released TriathlonTM PS Femoral Component in terms of intended use,
material, and general design features. The only difference is the removal of material
from the superior, posterior portion of the cam. Physical testing was performed to show
that the component could withstand load over ten million cycles.
4

DEPARTMENT OF EALTH & HUMAN SERVICES 
Public Health Service
Food and Drug Administration
JAN 1 2 2005 
9200CorporateBoulevard
Rockville MD 20850
Ms. Denise Duchene
Senior Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Commerce Court
Mahwah, New Jersey 07430
Re: K042993
Trade/Device Name: TriathlonTM Posteriorly Stabilized PS Femoral Component (5515)
Regulation Name: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/ metal/ polymer semi-constrained
cemented prosthesis
Regulatory Class: II
Product Code: JWH
Dated: October 29, 2004
Received: November 1, 2004
Deat Ms. Duchene:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
may be subject to such additional controls. Existing major regulations affecting your device can
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ms. Denise Duchene
This letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device
to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled,
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely yours,
f 
Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure

u-1¶ otS
510(k) Premarket Notification- TriathlonTM PS Fernoral Coimponent (5515)
510(k) Number (if known): 
K
Device: 
TriathionTM Posteriorly Stabilized (PS) Femoral Component (5515)
The TriathlonTM PS Femoral Component has undergone a design modification - material
has been removed from the superior, posterior aspect of the cam. This design change has
been made to improve the manufacturability of the component. The intended use of the
TriathlonTM PS Femoral Component is: it is intended to be used with TriathlonTM PS
tibial inserts, TriathlonTM Primary Cemented Tibial Tray, and TriathlonTM and/or
Duracon® patellar components in primary or revision cemented total knee arthroplasty.
Speeific indications:
Indications:
.
Painful, disabling joint disease of the knee resulting from: noninflanmmatory degenerative
joint disease (including osteoarthi/tis, traumatic arthritis or avascular necrosis) or,
rheumatoid arthritis
• Post-traumatic loss of kneejoint configuration and function.
* Moderate varus, valgus, or flexion deformiity in which the ligamentous structures can be
returned to adequate function and stability.
• Revision of previous unsuccessful knee replacement or other procedure.
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture management techniques.
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased
constraint.
* Absent or non-functioning or 
cciate 
i
(Divisionm Sign-Off)
DivisIn' cf Cnersl. Restorative,
and Neurologicti bcvices
510(k) Number 
< 
C 
Pagelof2

Prescription Use 
X 
AND/OR 
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) 
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and NeurologicaI Devices
510(k) Number-
Page 2 of 2

MAR 2 .9 2005
Special 5 10(k) Summary 
Ty
Proprietary Name: 
Size 1 Triathion TMPosterior 
Stabilized (PS)
Tibial Insert
Common Name: 
Modular Tibial Insert
Classification Name and Reference: 
Knee Joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrainied
Cemented Prosthesis
21 CFR §888.3560
Proposed Regulatory Class: 
Class II
Device Product Code: 
87 JWH-
Predicate Proprietary Name: 
Triathlon TM PS Tibial Insert - Sizes 1
Predicate Regulatory Class: 
Class IL
Predicate Product Code: 
87 JWH
For Information contact: 
Karen Ariemma
Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Phone: (201) 831-5718
Fax: (201) 831-6038
Date Prepared: 
March 21, 2005
Description/Technological Comparison
This premarket notification describes a modification to the articulating surface of the size
I Triathlon TM Posterior Stabilized Tibial Insert. This insert is intended to be used with the
size 1 Triathlon TM Primary Cemented Tibial Tray and the Triathlonm PS Femoral
component in primary or revision total knee arthroplasty. This size 1 tibial insert has
been modified for improved rotational constraint with the size 1 insert.
Intended Use
The intended use of the size one Triathlon TM Posterior Stabilized Tibial Insert is the same
as that of the predicate device described in premarket notification K03 1729 - it is
T~~~~~~~~~~~~~~~~~~~~~I
intended for use with TriathlonT m Posterior Stabilized femoral components, Triathlonm

Ko~~o539
Primary Cemented Tibial Tray, and TriathlonT m and/or Duracon® patellar components in
primary or revision cemented total knee arthroplasty. The Posterior stabilized design is
intended to substitute for the posterior cruciate ligament if it is absent or non-functioning.
Indications:
* Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or,
rheumatoid arthritis
* Post-traumatic loss of knee joint configuration and function.
* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be
returned to adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture management techniques
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased
constraint.
* Absent or non-functioning posterior cruciate ligament.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site,
*Any mental or neuromuscular disorder which would create an unacceptable risk of
prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• Bone stock compromised by disease, infection or prior implantation that cannot provide
adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity
and function.
* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to
failure of the fixation of the device or to failure of the device itself

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
4AN 2 
9ily 
?W9200CorporateBoulevard
Rockville MD 20850
Dr. Susan Krasny, Ph.D., RAC
Director, Regulatory Affairs and Clinical Research
Stryker Howmedica Osteonics
325 Corporate Drive
Mahwah, New Jersey 07430
Re: K050539
Device Name: TriathlonTM Knee System Posterior Stabilized (PS) Tibial Insert
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis
Regulatory Class: It
Product Code: JWH
Dated: February 28, 2005
Received: March 2, 2005
Dear Dr. Krasny:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976,
the enactment date of the Medical Device Amendments, or to devices that have been reclassified in
accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require
approval of a premarket approval application (PMA). You may, therefore, market the device, subject to
the general controls provisions of the Act. The general controls provisions of the Act include
requirements for annual registration, listing of devices, good manufacturing practice, labeling, and
prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class 11 (Special Controls) or class Ill (PMA), it may be
subject to such additional controls. Existing major regulations affecting your device can be found in the
Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further
announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set fbrth in the
quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Dr. Susan Krasny, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate
device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact
the Office of Compliance at (240) 276-_. Also, please note the regulation entitled, "Misbranding by
reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on
your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer
Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www. fda.nov/cdrh/industrv/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure

Page 
1 
of 
2
5 10(k) Number (if known): 
Koo 
'-~
t5
'
9
Device Name: 
Triathlon1 M Knee System - Posterior Stabilized (PS) Tibial Inserts
Intended Use:
The intended use of the size one Triathlon TM Posterior Stabilized Tibial Insert is the same
as that of the predicate device described in premarket notification K03 1729 - it is
intended for use with Triathlon TM PS femoral components, Triathlon' TM Primary Cemented
Tibial Tray, and Triathlon TM and/or Duracon® patellar components in primary or revision
cemented total knee arthroplasty. Specific indications/contraindications are listed below
(these are identical to the predicate):
Indications:
* Painititl, disabling joint disease of the knee resulting from: noniniflammatory degenerative
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or,
rheumatoid arthritis
* Post-traumatic loss of knee joint configuration and function.
* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be
returned to adequate function and stability.
*·Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture management techniques
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased
constraint.
* Absent or non-functioning posterior cruciate ligament.

IKo<o0 
9
Page 
2 
of 
2
Contraindications
• Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site
* Any mental or neuromuscular disorder which would create an unacceptable risk of
prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Bone stock compromised by disease, infection or prior implantation that cannot provide
adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity
and function.
* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to
failure of the fixation of the device or to failure of the device itself.
Prescription Use 
__ 
_ 
OR 
Over-the-Counter Use ......
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number 
6 765-3

KO4 17%9 
TriathlonT" Posteriorly Stabilized (PS) Total Knee System 
5 1 O(k) Premarket Notification 
Confidential 
SEP - 2 2003 
510(k) Summary 
Submission Information 
Name and Address of Sponsor: 
Howmedica Osteonics Corp. 
59 Route 17 
Allendale, NJ 0740 1 
For Information contact: 
Device Identification 
Proprietary Name: 
Margaret F. Crowe 
Regulatory Affairs Consultant 
Howmedica Osteonics Corp. 
59 Route 17 
Allendale, NJ 0740 1 
TriathlonTM Posteriorly Stabilized (PS) Total Knee 
System 
Common Name: 
Posteriorly Stabilized Total Knee Replacement 
Classification Name and Reference: 
Knee Joint Patellofemorotibial 
Polymer/Metal/Polymer Semi-constrained 
Cemented Prosthesis 
21 CFR 5888.3560 
Proposed Regulatory Class: 
Class I1 
Device Product Code: 
OR(87) JWH 
Prosthesis, Knee Patellofemorotibial, Semi- 
Constrained, Cemented, Polymer/Metal/ Polymer 
The TriathlonTM PS Total Knee system is comprised of a femoral component, tibial tray, 
and tibial insert that are intended to be used in total knee arthroplasty (ifreplacement of 
the articular surface of the patella is required, the DuraconB patellar components are 
compatible with the Triathlonl'" components). The TriathlonT" PS Total Knee System is 
intended to be used in situations where the posterior cruciate ligament is absent, or cannot 
be preserved. Specific indications and contraindications for the TriathlonT" PS Total 
Knee System are listed below: 
5 
2 

TriathlonTM 
Posteriorly Stabilized (PS) Total Knee System 
5 1 O(k) Premarket Notification 
Confidential 
Indications: 
Painful, disabling joint disease of the knee resulting fi-om: noninflammatory degenerative 
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, 
rheumatoid arthritis 
0 Post-traumatic loss of knee joint configuration and function. 
0 Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be 
returned to adequate function and stability. 
0 Revision of previous unsuccessful knee replacement or other procedure. 
0 Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard 
fracture management techniques. 
Additional Indications for Posterior StabiIized Components: 
Ligamentous instability requiring implant bearing surface geometries with increased 
constraint. 
Absent or non-fimctioning posterior cruciate ligament. 
Contraindications 
Any active or suspected latent mfection in or about the knee joint. 
Distant foci of infection which may cause hematogenous spread to the implant site 
Any mental or neuromuscular disorder which would create an unacceptable risk of 
prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 
Bone stock compromised by disease, infection or prior implantation that cannot provide 
adequate support and/or fixation to the prosthesis. 
Skeletal immaturity. 
Severe instability of the knee joint secondary to the absence of collateral ligament integrity 
and hction. 
Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to 
failure of the fixation of the device or to failure of the device itself. 
3 

bSl7Zq 
%SG 
3g5 
TriathlonTM 
Posteriorly Stabilized (PS) Total Knee System 
5 1 O(k) Premarket Notification 
Confidential 
Device Description 
The TriathlonTM Posteriorly Stabilized Total Knee System consists of three primary 
components: TriathlonTM Posteriorly Stabilized (PS) Femoral Component, TriathlonTM 
Primary Cemented Tibial Baseplate, and TriathlonTM 
Posteriorly Stabilized (PS) Tibial 
Insert. Optional TriathlonTM Femoral Distal Fixation Pegs are also available. If 
replacement of the articular surface of the patella is required, the DuraconO patellar 
components are intended for use with the TriathlonTh' Posteriorly Stabilized Femoral 
Components. 
The TriathlonTM Total Knee Posteriorly Stabilized Femoral Component is fabricated from 
cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to 
replace the articulating surface of the distal femur. This posteriorly stabilized femoral 
component is utilized when total knee replacement is indicated, and the posterior cruciate 
ligament is non-functioning or absent, resulting in joint instability. 
The TriathlonTM Total Knee Posteriorly Stabilized Femoral Component is available in 
right and left configurations, and eight proportional sizes to accommodate differences in 
patient anatomy. The interior surface of the component (except the interior surface of the 
PS box) is grit-blasted to increase surface roughness - this is intended to promote 
interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface 
texture and the apposing bone. This femoral component features an intercondylar box 
that engages the mating tibial insert eminence at 45" to 60" (depending upon size of 
implant). The superior portion of the box is open. This open box design is intended to 
reduce contact on the tibial insert eminence, and in the case of intra-operative or post- 
operative femoral fracture, allow the surgeon to use a retrograde femoral nail to treat the 
fracture. There are threaded attachment features on the distal and posterior aspects of the 
femoral component. The threaded attachment feature on the distal aspect of the 
component is to allow the use of modular pegs. 
4 

TriathlonTh' Posteriorly Stabilized (PS) Total Knee System 
5 1 O(k) Premarket Notification 
Confidential 
The TriathlonTM Primary Cemented Tibial Tray is fabricated from cast cobalt chromium 
molybdenum alloy. The TriathlonTM 
Primary Cemented Tibial Tray is neutral in 
configuration, and is available in eight proportional sizes. The undersurface of the tibial 
tray and the keel is grit blasted for interdigitation with PMMA bone cement. The keel of 
the tibial tray is designed with normalizations for rotational stability and cement 
interdigitation. The superior aspect of the tibial tray has a rim that contains tabs that 
mate with the outer periphery of the tibial insert, along with the locking wire used on the 
tibial insert. This locking feature is designed to provide secure attachment of the tibial 
insert to the tray, and is designed to reduce micromotion of the tibial insert on the tray. 
The TriathlonT" Posteriorly Stabilized (PS) Tibial Insert is neutral in configuration, and is 
available in eight proportional sizes and varying thicknesses (9mm, 1 Imm, 13mm, 
16mm, 19mm, 22mm, and 25mm). The insert is fabricated from ultra high molecular 
weight polyethylene and cobalt-chromium alloy. The minimum thickness of the tibial 
insert on the bearing surface is 6mm. The tibial insert features a tibial eminence (or post) 
that provides anterior/posterior constraint in clinical situations where the posterior 
cruciate ligament is absent or non-functional. As previously noted, the tibial eminence 
contacts the cam of the femoral component at 45-60 degrees of flexion. There is a relief 
on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar 
fat pad. 
The TriathlonTM PS Tibial Insert incorporates a locking wire feature on the anterior aspect 
of the insert. This locking wire is fabricated from cobalt-chromium alloy, and engages 
under tabs on the anterior rim of the TriathlonTM Primary Tibial Baseplate. This wire-tab 
locking mechanism secures the insert into the baseplate. 
Triathlon'" Distal Femoral Fixation Pegs are made available separate from the TriathlonTM 
Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an 
accessory to the TriathlonT" PS Femoral Component, and are optional for use. These 
pegs are designed to provide rotational stability, and to aid the surgeon in the placement 
5 

TriathlonTM 
Posteriorly Stabilized (PS) Total Knee System 
5 1 O(k) Premarket Notification 
Confidential 
of the femoral component on the prepared distal femur. The TriathlonTM 
Distal Femoral 
Fixation Pegs are fabricated from wrought cobalt chromium alloy. The distal portion of 
the fixation peg is threaded to allow the peg to be assembled to the distal threaded hole in 
the TriathlonTM 
PS Femoral component. The proximal portion of the peg is recessed to 
allow the use of a wrench to assemble the peg into the femoral component. 
Equivalent products include: 
1. DuraconO Monolithic Stabilizer Femoral Component 
2. Duracon@ Cruciform Tibial Baseplate 
3. Duracon@ PS Lipped Tibial Insert 
4. Scorpio@ Posteriorly Stabilized (PS) Total Knee System 
5. Series 7000 Standard Tibial Tray 
Testing was presented to support a claim of substantial equivalence to the predicate 
devices. 
6 

(4 
DFJJARTMENTOF"&HUMANSERWCES 
Public Health Service 
Food and Drug Administration 
9200 Corporate Boulevard 
Rockville MD 20850 
*k, 
SEP = 2 2003 
Mr. William J. Cymbaluk 
Vice President 
Quality AssuranceRegulatory Affairs/Clinical Research 
Howmedica Osteonics Corp. 
59 Route 17 
Allendale, New Jersey 0740 1 - 1677 
Re: KO31729 
Trade/Device Name: Triathlon'" Posteriorly Stabilized (PS) Total Knee System 
Regulation Numbers: 21 CFR 888.3560 
Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi- 
Regulatory Class: I1 
Product Codes: JWH 
Dated: June 3, 2003 
Received: June 4,2003 
constrained cemented prosthesis 
Dear Mr. Cymbaluk: 
We have reviewed your Section 5 10;(k) premarket notification of intent to market the device 
referenced above and have determined the device is substantially equivalent (for the indications 
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 
You may, therefore, market the device, subject to the general controls provisions of the Act. The 
general controls provisions of the Act include requirements for annual registration, listing of 
devices, good manufacturing practice, labeling, and prohibitions against misbranding and 
adulteration. 
If your device is classified (see above) into either class I1 (Special Controls) or class 111 (PMA), it 
may be subject to such additional controls. Existing major regulations affecting your device can 
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 
publish further announcements concerning your device in the Federal Register. 
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 
that FDA has made a determination that your device complies with other requirements of the Act 
or any Federal statutes and regulations administered by other Federal agencies. You must 
comply with all the Act's requirements, including, but not limited to: registration and listing (21 
CFR Part 807); labeling (2 1 CFR Part 80 1); good manufacturing practice requirements as set 
forth in the quality systems (QS) regulation (2 1 CFR Part 820); and if applicable, the electronic 
product radiation control provisions (Sections 53 1-542 of the Act); 2 1 CFR 1000- 1050. 

Page 2 - Mr. William J. Cymbaluk 
This letter will allow you to begin marketing your device as described in your Section 5 I O(k) 
premarket notification. The FDA finding of substantial equivalence of your device to a legally 
marketed predicate device results in a classification for your device and thus, permits your device 
to proceed to the market. 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 
contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, 
"Misbranding by reference to premarket notification" (2 1 CFR Part 807.97). You may obtain 
other general information on your responsibilities under the Act from the Division of Small 
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-204 1 or 
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html 
Sincerely yours, 
Celia M. Witten, Ph.D., M.D. 
Director 
Division of General, Restorative 
and Neurological Devices 
Office of Device Evaluation 
Center for Devices and 
Radiological Health 
EncIosure 

TriathlonTM Posteriorly Stabilized (PS) Total Knee System 5 lqk) Premarket Notification 
5 1 O(k) Number (if known): 
K 03 1729 
Device: 
TriathlonTM Posteriorly Stabilized (PS) Total Knee System 
The Triathlon PS Total Knee system is comprised of femoral components, tibial trays, 
and tibial inserts that are intended to be used with the patellar components of the 
DuraconB system in primary and revision total knee arthroplasty. The TriathlonTM PS 
Total Knee System is intended to be used in situations where the posterior cruciate 
ligament is absent, or cannot be preserved. Specific indications and contraindications for 
the Triathlon PS Total Knee System are listed below: 
Indications: 
0 Painhl, disabling joint disease of the knee resulting from: noninflammatory degenerative 
joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, 
rheumatoid arthritis 
0 Post-traumatic loss of knee joint configuration and function. 
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be 
returned to adequate function and stability. 
0 Revision of previous unsuccessful knee replacement or other procedure. 
0 Fracture of the distal femur andor proximal tibia that cannot be stabilized by standard 
fracture management techniques. 
' 
Additional Indications for Posterior Stabilized Components: 
0 Ligamentous instability requiring implant bearing surface geometries with in 
constraint. 
0 Absent or non-functioning posterior cruciate ligament. 
Con t rai nd i ca t i o ns 
0 Any active or suspected latent infection in or about the knee joint. 
0 Distant foci of infection which may cause hematogenous spread to the iniplan 

KO3 17z9 
0 Any mental or neuromuscular disorder which would create an unacceptable risk of 
prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 
0 Bone stock compromised by disease, infection or prior implantation that cannot provide 
adequate support and/or fixation to the prosthesis. 
Skeletal immaturity. 
0 Severe instability of the knee joint secondary to the absence of collateral ligament integrity 
and fhction. 
+ Obesity. An overweight or obese patient can produce loads on the prosthesis that can 
lead to failure of the fixation of the device or to failure of the device itself. 
The TriathlonTM PS Femoral Component and the TriathlonTM Primary Cemented Tibial 
Baseplate are intended to be implanted using bone cement. 
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE 
IF NEEDED) 
Concurrence of CDRH, Office of Device Evaluation (ODE) 
Prescription Use 
OR 
Over-the Counter-Use 
(per 2 1 CFR 
801.109) 
(Division Sign-OW 
Division of Gostal. Restorative 
and Neuro1ogi;al Devices 

Triathlon® X3TM UHIMWPE Tibial and Patellar Components 
510(k) Premarket Notification
JUL 1 3 2005
510(k) Summary of Safety and Effectiveness
Device: 
Triathlon® X3M" UHMWPE Tibia] Inserts and Patellar Components
Classification: 
21 CFR 888.3560- Knee joint, patellofemorotibial,
polymer/metal/polymer semi-constrained cemented prosthesis
Product Code 
87 JWH,
Predicate Devices: 
Triathlon® Tibial Inserts and Patellar
Contact Person: 
Karen Ariemma
Senior Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5718
(201) 831-6038 (FAX)
karen.ariemma~stryker.com
Date Summary Prepared: 
May 3, 2005
The Triathlon®W
; X3TM UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and
the Triathlon : X3TM UHMWPE Patellar components are intended to be used with the cemented
Triathlon® PS and CR femoral components and cemented Triathlon® Primary Cemented Tibial
Tray in primary or revision total knee arthroplasty. The Triathlon® X3TM UHMWPE Patellar
components are intended to be used with the femoral components of the previously released
Duracon® Total Knee System The Triathlon ® PS Total Knee System is intended to be used in
situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon x
CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is
present. The all polyethylene Triathlon® X3TM UHMWPE Patellar components are intended for
implantation with bone cement only.
Indications:
* Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease
(including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid arthritis.
* Post-traumatic loss of kneejoint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to
adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture
management techniques.

Yo 
cis I I 
2 
z)
Tnathlon® X3TM UHMWPE Tibial and PatelJar Components 
510(k) Premarket Notification
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased constraint.
* Absent or non-functioning posterior cruciate ligament.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site.
* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis
instability, prosthesis fixation failure, or complications in postoperative care.
* Bone stock compromised by disease, infection or prior implantation that cannot provide adequate
support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and
function.
* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of
the fixation of the device or to failure of the device itself.
Device Description
The device includes tibial and patellar components of a total knee system. These components are
used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and
patella. Tibial inserts will be made in Cruciate Retaining and Posterior Stabilized designs.
Patellar components will be made in both Asymmetric and Symmetric designs.
Summary of Data
A risk analysis and research and development testing have been performed to demonstrate
equivalence of the subject products to the predicate devices. Testing and analysis includes
material properties testing, wear testing, disassembly force evaluation, multi-axis fatigue testing,
patella shear testing and finite element modeling of contact stresses.
2

DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
JUL 13 005 
Rockville MD 20850
Ms. Karen Ariemma
Senior Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
Re: K051146
Trade/Device Name: Triathlon® X3TM UHMWPE Tibial Inserts and Patellar Components
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial, polymer/metal/polymer semi-constrained
cemented prosthesis
Regulatory Class: IL
Product Code: JWH
Dated: May 3, 2005
Received: May 4, 2005
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
may be subject to such additional controls. Existing major regulations affecting your device can
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
north in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 5 10(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device
to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled,
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
k 
MriaC. rovstPh.D.
Acting Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure

5 10(k) Number (if known):
Device Name: Triathlon® Knee System
Indications for Use:
The Triathlon® X3TM UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and
the Triathlon® X3TM UHMWPE Pateliar components are intended to be used with the cemented
Triathlon® PS and CR femoral 'components and cemented Triathlon ® Primary Cemented Tibial
Tray in primary or revision total knee arthroplasty. The Triathlon® X3TM UHMWPE Patellar
components are intended to be used with the femoral components of the previously released
Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in
situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon®
CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is
present. The all polyethylene Triathlon® X3TM UHMWPE Patellar components are intended for
implantation with bone cement only.
Indications:
• Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease
(including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid arthritis.
·
Post-traumatic loss of knee joint configuration and function.
* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to
adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
* Fracture of the distal femur and/or pmximal tibia that cannot be stabilized by standard fracture
management techniques.
Additional Indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased constraint.
* Absent or non-functioning posterior cruciate ligament.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
·
Distant foci of infection which may cause hematogenous spread to the impliint site. -
·
Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis
instability, prosthesis fixation failure, or complications in postoperative care.
* Bone stock compromised by disease, infection o prior implantation that cannot provide adequate
support and/or fixation to the prosthesis.
(Division SPage 
I 
of 
2
Division of General, Resto( tiv
and Neurological Devices
510(k) Number J\ 
I

}S§~1 44(f) .2 o~ 2')
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and
function.
* Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of
the fixation of the device or to failure of the device itself.
Prescription Use 
X 
OR 
Over-the-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 
2 
of 
2
(Division Sgn-OMI
Division of General, Restorative,
and Neurological Devices
510(k) Number_ _ r> C / [ '5 (~

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix B 
 
Suggested Radiographic Technique 

Suggested Radiographic Techniquei 
 
The following views are required preoperatively and at each postoperative interval specified 
according to the evaluation schedule to enable evaluation of the bone-prosthesis interfaces. 
 
AP 
 
ML 
 
Merchant (30° of flexion) 
General Requirements 
A. Appropriate corrections in radiological exposure setting are needed for obese subjects. 
B. At least a 14”x17” sized film should be used. 
C. If the subject is bilateral and a view showing both knees is submitted, two copies of that 
view are required. 
D. Both digital and film radiographs are acceptable.  Digital films must be in uncompressed 
DICOM format. 
E. A view capturing the complete prosthesis must be submitted to Stryker.  Radiographs 
incompletely displaying components will be rejected. 
F. Each image must have: 
a. Subject’s identification number 
b. Subject’s initials 
c. Date of radiograph 
d. Indication of operative side in the study 
e. Markers for right and left sides, as applicable 
f. 
Visit interval 
AP 
A. Standard technique 
a. The subject should be supine with the knee in full extension and the leg positioned 
neutrally. 
b. The x-ray beam should be directed vertically to the study knee with 5° to 7° 
angulation toward the subject’s head. 
c. The femoral component, the medial and lateral femoral epicondyles, tibial 
component and an unobstructed view of the polyethylene tibial insert must be 
visible on film as shown below.  
 
Refer to Figure 1 for an acceptable AP radiograph.                 

 
Fi g ur e 1.  A P Vi e w - A c c e pt a bl e 
 
M L 
A.  St a n d ar d t e c h ni q u e 
a.  T h e s u bj e ct s h o ul d b e l yi n g fl at o n t h e s a m e si d e a s t h e st u d y k n e e.  T h e k n e e 
s h o ul d b e fl e x e d 2 5° t o 3 0°. 
b.  T h e x-r a y b e a m s h o ul d b e dir e ct e d v erti c all y t o w ar d t h e m e di al a s p e ct of t h e k n e e 
j oi nt p er p e n di c ul ar t o t h e pl a n e of t h e e xtr e mit y. 
c.  T h e p at ell a, t h e p at ell ar c o m p o n e nt, o v erl a p pi n g p o st eri or c o n d yl e s of t h e 
f e m or al c o m p o n e nt a n d ti bi al c o m p o n e nt, all i n pr ofil e, m u st b e vi si bl e i n t hi s 
r a di o gr a p h. 

Refer to Figure 2 for an acceptable ML radiograph. 
 
Figure 2.  ML View - Acceptable 
Merchant (30° of flexion) 
A. Standard technique 
a. The subject should be supine with his/her knee flexed about 30° at the table’s edge. 
b. A device should be use to maintain flexion at this angle, to which the film cassette 
should be attached. 
c. The x-ray beam should be directed through the patella at 60° from the vertical axis. 
d. The articular surface of the patella and femur must be visible. 
 
Refer to Figure 3 for an acceptable Merchant (30° of flexion) radiograph. 
 
Figure 3.  Merchant (30° of Flexion) View – Acceptable 
                                                 
i Greenspan, A. (1992). Orthopedic radiology: A practical approach (2nd ed.). New York: Gower Medical 
Publishing. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix C 
 
Retrieved Implant Analysis Protocol 
 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
  
 
 
 
 
 
RETRIEVED IMPLANT ANALYSIS PROTOCOL 
Triathlon Tritanium Knee Outcomes Study 
 
 
PURPOSE: 
To evaluate retrieved Stryker Orthopaedics Triathlon Tritanium Tibial Baseplates, Triathlon 
Tritanium Patellae and other ancillary components and/or adjacent tissues in order to help 
characterize patterns of wear and potential device-related complications. 
 
METHODS: 
A. 
Subject Selection: 
Surgeons participating in the Stryker Orthopaedics Triathlon Tritanium Knee Outcomes 
Study [510(k) clearance #K123486 – May 3, 2013 and 510(k) clearance #K132624 –
November 26, 2013 will be asked to comply with the Retrieved Implant Analysis 
Protocol.  Whenever possible, subjects who undergo revision/removal of the Stryker 
Orthopaedics Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella and/or 
other ancillary components will be included in this analysis.  Subjects will be asked to 
consent to having their implants analyzed.  A sample Informed Patient Consent Form, 
including a section for implant analysis, is attached to this protocol as Appendix E. 
 
This study protocol will comply with the 2002 HIPAA privacy rule.  As such, Stryker will 
only collect that information which is necessary to support the objectives of the study 
protocol.  Stryker will take precautions to ensure that data received is as de-identified as 
possible.  In the case that some identified information is received, Stryker will ensure 
that any identifying information is not reported.  Study subjects will authorize Stryker to 
use their retrieved implant(s) and health information in support of the study protocol by 
completing and signing the Informed Patient Consent Form.  A subject also has the 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
  
 
 
 
 
 
option to sign the Informed Patient Consent Form for study participation but decline 
participation in the Retrieved Implant Analysis Protocol by not signing that section of the 
consent.  Should a subject choose to withdraw authorization, Stryker may use data 
collected prior to the withdrawal of authorization in order to maintain data integrity.  
 
B. 
Specimen Handling: 
The Stryker Orthopaedics Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium 
Patella and/or ancillary component(s) obtained at the time of revision/removal should be 
placed in neutral buffered formalin.  Any tissue samples submitted along with the implant 
must have been fixed in 10% formalin.  Each specimen container should be carefully 
labeled with subject initials, operative side, surgeon name and the component(s) 
included for analysis.  Whenever possible, relevant radiographic studies and a clinical 
summary should be submitted along with the specimen.   
 
Specimens should be carefully sealed and mailed by express mail to: 
Stryker Orthopaedics 
Attn: Loaner Dept, Dock K 
325 Corporate Drive 
Mahwah, NJ  07430 
 
Recommendations for packing and shipping explants are attached to this protocol.  
Ensure a copy of the relevant PER is included with the specimen for appropriate 
identification of the component(s). 
 
 
 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
  
 
 
 
 
 
 
Recommendations for Packing and Shipping Explants  
To Stryker Orthopaedics 
 
 
Please contact the Triathlon Tritanium Knee Outcomes Study CSM, identified on the Stryker 
Orthopaedics Contact Sheet, via phone to obtain an Exakt Pack Retrieval Shipping Container at 
least 1 week prior to scheduled revision/removal surgery.  
 
All specimens should be placed into a sufficient quantity of 10% formalin for a minimum of  
24 hours prior to shipping.  
 
After the specimens have been immersed in 10% formalin for a minimum of 24 hours, they 
should be transferred to a leak proof container with a quantity of 10% formalin sufficient to keep 
the specimens moist. 
 
Using the Exakt Pack container as directed in the detailed Instructions For Use also acts to 
insulate any leakage from the shipping handlers. 
 
Seal the shipping container securely.  Send via express mail to: 
 
Stryker Orthopaedics 
Attn: Loaner Dept, Dock K 
325 Corporate Drive 
Mahwah, NJ  07430 
 
 
RESULTS 
A report suitable for routine patient care will be provided to each surgeon by request.   
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix D 
 
Study Advertisements 
 

Clinical Trial with the Triathlon Tritanium Tibial Baseplate and Patella 
 
 
Dr. (name) of (practice) is participating in a clinical study evaluating a new 
primary knee replacement for cementless use in patients who are eligible for a 
primary total knee replacement.   
 
 
The Triathlon Tritanium Tibial Baseplate and Patella are intended for 
cementless, press-fit use.  They are compatible with other Stryker components 
as well.  This baseplate and patella are currently being sold in the United States 
and are implanted in patients who need primary knee surgery. 
 
Dr. (name) is one of 5 to 10 surgeons nationwide selected to enroll qualifying 
patients into this clinical study. The data collected will be used to evaluate both 
short and long-term (10-year) performance of the components following surgery.  
 
The study includes males and non-pregnant females between 18 and 75 years of 
age.  These patients must be candidates for a primary knee replacement.  These 
patients must also be able to comply with requirements following surgery 
including weight bearing restrictions and self-evaluation questionnaires.  Enrolled 
patients will be required to come in for an evaluation and x-rays before surgery 
and follow-up evaluations and x-rays at 6 weeks, 6 months, 1 year, 2 years, 5 
years and 10 years, and will be sent 3 questionnaires for completion at 3 years, 
4 years, 6 years, 7 years, 8 years and 9 years after surgery.     
 
Meeting all of the above criteria does not guarantee participation in the study.  
Further consultation and a screening evaluation with the physician are necessary 
to ensure this is the right study for you.  Study personnel at the site will explain 
all the details of the study to you so you can make an informed decision as to 
whether or not you would like to participate.   
 
 If you are interested in participating in this study, please contact Dr. (name) or 
(study coordinator name) at the numbers listed below for further details.  
  
Your request for information about this study in no way commits you to 
participate.  In order to participate, you will have to meet specific criteria and 
sign a consent form that details all aspects of the study, the device and the risks 
associated with primary knee surgery.     
 
Dr. (name) 
 
 
 
 
 
Study Coordinator Name 
 
 
Practice Name 
 
 
 
 
Title 
Telephone Number   
 
 
 
Telephone Number 
 
 
 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
 
 
 
 
 
 
 
 
 
Appendix E  
 
Model Informed Patient Consent

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
Informed Patient Consent 
 
 
I. 
Study Title:  A prospective, post-market, multi-center evaluation of the clinical outcomes 
of the Triathlon Tritanium Knee System. 
II. 
Description of the Study  
You have been asked be in this research study because your doctor thinks you need 
surgery to replace your knee joint.  About 500 people from up to 10 different hospitals 
will be in this study.   
The reason this study is being done is to see how successful a knee replacement using 
parts called the Triathlon Tritanium Tibial Baseplate and Triathlon Tritanium Patella will 
be. These parts will be put in using no bone cement. The study will be able to tell how 
well the knee replacement parts work by looking at whether there is a need to remove or 
replace the baseplate because of the baseplate getting loose near the bone, and not 
because of an infection. This will be compared with how much this happens to patients 
who have a knee replacement that was put in using bone cement.   
This study is being done by Stryker Orthopaedics (the maker of the knee replacement, 
also called the Sponsor) and your doctor. We are doing this study to find out if the 
Stryker Orthopaedics Triathlon Tritanium cementless knee replacement works as well as 
a cemented knee replacement. 
Your doctor and his staff will ask you some questions during this visit. Based on the 
requirements of the study, you may or may not be chosen to be in the study. 
Fitting all of these requirements does not mean you will be in the study. The doctor also 
has to examine you to make sure the study is right for you.  The staff at the doctor’s 
office will tell you everything about the study. Then you can decide if you want to be in 
the study or not. 
This study has two sections that you can be in. These are called Cohort (Group) 1 and 
Cohort (Group) 2. Group 1 is made up of patients who get the Triathlon Tritanium 
cementless knee replacement. Group 2 is made up of patients who get a Triathlon CR or 
PS cemented knee replacement. Group 2 is called the control group. Your doctor will tell 
you if you will be in Group 1 or Group 2. 
 
Group 1- Cementless Knee Replacement 
If you are in Cohort 1 of the study, you will be in the study for the next 10 years.  Your 
doctor will examine you before surgery and during surgery. Then he will examine for the 
study you again after your surgery. These exams will be 6 weeks, 3 months 1 year, 2 
years, 5 years, and 10 years after your surgery. 
During the visit before surgery you will need to fill out four forms about your health. Your 
doctor will also collect other information and x-rays that would be collected at a normal 
visit.  
You will have surgery and your doctor will tell us the details of your surgery. 
Patient’s Initials ______ 
 
   Page 1 of 6 
Version: 1____________ 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
During your visits to the doctor 6 weeks, 3 months, 1 year, 2 years, 5 years, and 10 
years after surgery, your doctor will figure out how well your knee is working. He will also 
take three x-rays. These x-rays are the same kind you would have if you were not in the 
study.  
At your visits to the doctor 6 weeks, 1 year, 2 years, 5 years, and 10 years after surgery, 
your doctor will ask you to fill out three forms. At 3 months you will fill out one form. 
These forms will be about your health. You will also need to fill out three forms over the 
mail 3 years, 4 years, 6 years, 7 years, 8 years, and 9 years after your surgery. 
 
Group 2- Cemented Knee Replacement 
If you are in Group 2 of the study, you will be in the study for the next 5 years.  Your 
doctor will examine you before surgery and during surgery. Then he will examine for the 
study you again after your surgery. These exams will be 6 weeks, 6 months 1 year, 2 
years, and 5 years after your surgery. 
During the visit before surgery you will need to fill out four forms about your health. Your 
doctor will also collect other information and x-rays that would be collected at a normal 
visit.  
You will have surgery and your doctor will tell us the details of your surgery. 
During your visits to the doctor 6 weeks, 3 months, 1 year, 2 years, and 5 years after 
surgery, your doctor will figure out how well your knee is working. He will also take three 
x-rays. These x-rays are the same kind you would have if you were not in the study.  
At your visits to the doctor 6 weeks, 1 year, 2 years, and 5 years after surgery, your 
doctor will ask you to fill out three forms. At 3 months you will fill out one form. These 
forms will be about your health. You will also need to fill out three forms over the mail 3 
years and 4 years after surgery. 
 
III.   
Condition and Care after Surgery 
Your doctor will tell you what to do to get better after your surgery.  Like with any 
surgery, your body takes time to heal.  That amount of time will be related to the surgery 
and your health.  While you are healing, you may experience pain because of the 
surgery. This pain might last a few months after the surgery. 
Your doctor will tell you to use crutches, a walker, or a cane after your surgery.  This will 
take some weight off of your knee. This can help your knee replacement last longer. You 
must follow your doctor’s orders on using a cane, crutches, or walker.   
The goal of this surgery is to lessen pain and make your knee work better.  You will need 
to see your doctor at 6 weeks, 3 months, 1 year, 2 years, and 5 years after your surgery, 
and if you are in Group 1 also at 10 years after surgery, so your doctor can see if your 
knee replacement is doing well. 
IV. 
Possible Risks 
This study looks at how well a knee replacement works. It is typical for this kind of study.  
The Food and Drug Administration (FDA) already allows this knee replacement to be 
Patient’s Initials ______ 
 
   Page 2 of 6 
Version: 1____________ 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
sold in the United States.  There are no extra risks for you because you are in this study, 
just the normal risks of knee replacement surgery.  You may need to spend a little more 
time in the doctor’s office to fill out paperwork.  If the doctors and scientists find out any 
new information during this study that might make you change your mind about being in 
the study, you will get that new information. 
 
There are some risks in knee  surgery.  These might be:  moderate to severe pain; 
breaking the knee replacement parts or the surrounding bones; movement of parts of the 
replacement inside your body; parts of the replacement sinking; parts of the replacement 
moving out of their normal position; allergies to the metal parts of the replacement; 
removal of one or more of the parts; loosening and infection; rubbing of parts of the 
replacement which might lead to losing part of the bone; disorders of the nerves 
involving your legs; damage to the nerves;  abnormal building up of bone; changes in 
movement of your blood related to your heart, blood and lymph vessels; problems with 
urinating; problems with your stomach or intestines; problems with blood vessels like 
blood clots; lung problems like pneumonia; a clogged blood vessel; or a heart attack. 
V.  
Potential Benefits 
You might not benefit personally from being in the study, but the results might help out 
others that have knee replacement surgery in the future. 
VI. 
Other Types of Treatment 
You have talked about other possible treatments with your doctor. These treatments 
might be: conservative treatment that is not surgery or no treatment at all. 
You can say no to being a part of this study.  This will not change any part of your knee 
surgery.  Your doctor can tell you detailed facts about this treatment and the benefits of 
other types of treatment you can have. You should feel free to talk with your doctor 
about other options.  
VII. 
Making Financial Information Known 
Your doctor and/or the hospital can be paid money from the company that made the 
knee replacement. This money would be to pay for the cost of doing the study or for 
other reasons. If you want to know more about this you can ask your doctor or his staff.  
VIII. 
Privacy 
If you say yes to being a part of this study, your medical records and identity will be kept 
private. They will be kept private based on the law. The records will not be given to 
anyone unless you give written permission.   
If you sign this consent form you allow Stryker Orthopaedics employees to see your 
medical records. You also allow people to see your records who look at how safe and 
effective medical products are. These people also make sure that medical treatment and 
research studies are safe. Your name and identity will not be in those records. 
IX.  
Cost to Be in the Study 
Patient’s Initials ______ 
 
   Page 3 of 6 
Version: 1____________ 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
Your knee surgery should be covered by your insurance carrier. You will not be paid to 
be in the study. 
 
X. 
Device Retrieval Analysis Study 
 
I understand that [Investigators Names]  may need to take knee replacement parts out of 
my body during the study. If this happens, Stryker Orthopaedics has a procedure to test 
the parts.   
 
I understand that Stryker Orthopaedics Corporation makes the implant and runs the 
study. I understand that Stryker Orthopaedics will ask my doctor to send any removed 
knee replacement parts to them. My doctor will send them to the Product Surveillance 
department at Stryker Orthopaedics. They will test these parts, and this can be a part 
part of being in the study.  
 
I allow my doctor and to give Stryker Orthopaedics (the Sponsor) any knee implant parts 
that have been removed. I also allow my doctor to give Stryker Orthopaedics other 
information. This other information is my name, birth date, and details about my knee 
surgery. Then they can test the knee replacement parts that have been taken out. They 
can give the company and the doctor the results of those tests.  
 
My doctor will get the results of this testing. I understand that I will not get these parts 
back. I also understand that I will not get the results of any tests that are done on those 
parts. 
 
I understand that nobody outside of the Sponsor will see my removed knee replacement 
parts.  
 
I understand that I will let my doctors and the Sponsor see information about my identity. 
I also understand that nobody else will see that information. I understand that if I want to 
see this information I can ask my doctor for it. 
 
I understand that I can I decide I do not want to let these knee replacement parts to be 
used anymore. I can also decide if I do not want my identity information to be used 
anymore. I understand that I will need to say this in writing. I understand that any 
information from before that is still allowed to be used. 
 
Records about me will be kept private.  I can choose whether I want to allow my knee 
replacement parts to be studied if they are taken out. I understand I am allowed to say 
no to having my knee replacement parts studied. I also understand that I can stop being 
in the study whenever I want. If I choose to stop being in the study, my doctor will not 
change my care or treatment.  
 
I have signed below and have read and understood what is written above. I agree to 
allow the Sponsor to study any knee replacement parts removed from me. I allow for 
information about my identity to be released.  My signature shows that I have had a 
chance to ask questions about this removed knee replacement parts study. My doctor 
has answered these questions. I have been given a copy of the consent form.   
 
Patient’s Initials ______ 
 
   Page 4 of 6 
Version: 1____________ 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
 
 
           
                                                       _____     
 
_____________                                             
Signature of Subject/Legal Representative  
 
Date 
XI. 
Clinical Trial Website Posting 
 
A description of this clinical trial will be on the website http://www.Clinical Trials.gov. The   
U.S. law says it has to be posted on that website. This Web site will not have any 
information that can tell other people who you are. The Web site will show some of the 
results, or maybe even less than that. You can search this Web site whenever you want. 
XII. 
Payment and Medical Treatment Related to Injury 
The Sponsor will not give you any money if you have a medical problem related to 
surgery. Stryker Orthopaedics will not give you free medical treatment. If you have a 
medical problem related to your surgery you should call [Investigators Names] as soon 
as you can at [Phone Number].  
[Institution Name] will not give any money back or free treatment to you either. 
[Investigators Names] should tell you about what the hospital does if you have a 
complication. By signing this consent form you are not getting rid of any of your rights. 
Your doctor is still responsible if he does something wrong. 
XIII.   Access to Data and Privacy 
By being part of this study, you are letting your doctor and his staff give the Sponsor 
information about your health. You also allow people to see your records who look at 
how safe and effective medical products are. These people also make sure that medical 
treatment and research studies are safe. This is required by the law.  This health 
information includes all information from the study.  It may also include other health 
information in your medical records. Some of this health information might be from 
before you joined the study. 
The Sponsor will only collect information that they need for the study. They will make 
sure that the information they get does not have your name or address on it. They will 
make sure that no one else will see information about your identity. 
The Sponsor will use information about your health to do the study. They will use the 
results of the study to make sure the company’s knee replacement parts are working 
well. They will also use the results to improve the parts that they make. They might also 
use the information to design new parts.  
This permission to use your information does not have an ending date. You can take 
back this permission to release your health information at any time. You can do this by 
telling your doctor in writing. If you say you do not want to be in the study anymore it will 
not change the work that has already been done in the study. You have to sign this 
consent form to be in the study. This form also lets your health information be seen by 
those groups mentioned before. If you take back this consent you cannot be in the study 
Patient’s Initials ______ 
 
   Page 5 of 6 
Version: 1____________ 

Triathlon Tritanium Knee Outcomes Study 
Confidential 
 
anymore. At the end of the study information about your identity cannot be used 
anymore.  
XIIV. 
People to Contact 
If you have any questions you can call [IRB Name] IRB at [IRB Phone Number]. You can 
also ask them if you want to know your rights as part of the study.  You should contact 
Dr. [Investigators Names] as soon as you can at [Phone Number] if you have an injury 
that is related to the study. 
 
XV.  
Being in the Study 
Being part of this study is your choice.  If you do not choose to be in the study you will 
not lose any benefits that you are supposed to have.  You can decide you do not want to 
be in the study anymore and will not lose the benefits you are supposed to have.   
By signing and dating this form below, you are saying you have read and looked over all 
sections of this Informed Consent Form. You are also saying someone has answered all 
of your questions. You are also saying voluntarily consent to be in this research study.  If 
you do not sign this form, you will not be allowed to be in the research study. 
 
_______________________________________ 
Printed name of Subject/Legal Representative 
 
_______________________________________ 
__________       
Signature of Subject/Legal Representative                                     Date Signed     
 
 
 
_______________________________________ 
 
          __________ 
Signature of Person conducting the consent process                     Date Signed 
 
_______________________________________ 
 
__________       
 
Signature of Investigator 
                             Date Signed 
 
A signed and dated copy of this consent form must be given to the patient.   
Patient’s Initials ______ 
 
   Page 6 of 6 
Version: 1____________ 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix F 
 
Draft Specifications for Electronic Case Report Forms  
 

Page 1 of 1 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
Termination Date: 
-
-
 DD-MMM-YYYY    
Operative Side 
Left 
Right 
Study Termination  
 
1. Did subject complete study according to protocol (Please choose one): 
a. 
 Yes 
b. 
 No (if no, please select primary reason below) 
 
2. Primary reason for termination (Please choose one): 
a. 
 Screen failure 
b. 
 Death 
c. 
 Investigative site termination 
d. 
 Lost to follow-up 
i. 1st phone call date: 
-
-
 DD-MMM-YYYY  
ii. 2nd phone call date: 
-
-
 DD-MMM-YYYY 
iii. 3rd phone call date: 
-
-
 DD-MMM-YYYY 
iv. Certified letter date: 
-
-
 DD-MMM-YYYY 
v. Additional efforts: ______________________  
e. 
 Revision/Removal of the tibial baseplate 
f. 
 Subject withdrawal 
g. 
 Surgery not performed 
h. 
 Other (specify): ______________________________ 
 
3. Was study device in place at last contact (Please choose one): 
a. 
 Yes 
b. 
 No 
 
 
 
 
Comments: 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

Page 1 of 2 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
Event Onset Date: 
-
-
 DD-MMM-YYYY    
Operative Side 
Left 
Right 
Adverse Event  
 
1. When did event occur (Please choose one):  
a. 
 Pre-op 
b. 
 Peri-op 
c. 
 Post-op 
 
2. Adverse event (Please choose one): 
a. 
 Arthrofibrosis 
b. 
 Deep joint infection 
c. 
 Excessive knee pain 
d. 
 Femoral fracture 
e. 
 Loosening femoral component 
f. 
 Loosening patella component 
g. 
 Loosening tibial component 
h. 
 Myositis ossificans 
i. 
 Patella component dislocation 
j. 
 Patella fracture 
k. 
 Patella subluxation 
l. 
 Patella tendon rupture 
m. 
 Peroneal nerve palsy 
n. 
 Prosthesis fracture / femoral component 
o. 
 Prosthesis fracture / patella component 
p. 
 Prosthesis fracture / tibial component 
q. 
 Prosthesis fracture / tibial insert 
r. 
 Reflex Sympathetic Dystrophy (RSD) 
s. 
 Soft tissue trauma 
t. 
 Superficial wound infection 
u. 
 Supracondylar fracture 
v. 
 Tibial component subsidence 
w. 
 Tibial fracture 
x. 
 Wound hematoma 
y. 
 Wound related (specify): ________________________ 
z. 
 Operative site other (specify): _____________________ 
aa. 
 Bronchopulmonary (event description): ______________________ 
bb. 
 Carcinoma (event description): ______________________ 
cc. 
 Cardiovascular (event description): ______________________ 
dd. 
 Dermatological (event description): ______________________ 
ee. 
 Gastrointestinal (event description): ______________________ 
ff. 
 Genitourinary (event description): ______________________ 
gg. 
 Neurosensory (event description): ______________________ 
hh. 
 Pulmonary embolism 
ii. 
 Thrombophlebitis 
jj. 
 Trauma (event description): ______________________ 
kk. 
 Systemic other (event description): ______________________ 
 
 
3. Describe the event circumstances: _______________________________________ 
 
4. Device related (for Yes & uncertain a PER must be filed and Stryker must be contacted within 24hrs) 
a. 
 Yes 
b. 
 No 
c. 
 Uncertain 
 
 
 

Page 2 of 2 
 
5. Seriousness 
a. 
 Resulted in inpatient hospitalization 
b. 
 Resulted in prolonged existing hospitalization 
c. 
 Resulted in persistent or significant disability/incapacity 
d. 
 Resulted in permanent impairment of a body function or permanent damage to a body structure 
e. 
 Necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent 
damage to a body structure 
f. 
 Was a life threatening situation 
g. 
 Resulted in subject death 
h. 
 None 
 
6. Date AE became serious. If serious date is same as the onset date, enter the onset date:  
-
-
 DD-MMM-YYYY 
 
Treatments 
 
1. 
 None 
 
2. Revisions/Removals: 
a. 
 Femoral component   
 
 
-
-
 DD-MMM-YYYY 
b. 
 Tibial baseplate (complete termination form)  
-
-
 DD-MMM-YYYY 
c. 
 Tibial insert   
 
 
 
-
-
 DD-MMM-YYYY 
d. 
 Patellar component   
 
 
-
-
 DD-MMM-YYYY 
 
3. Reoperations 
a. Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
b. Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
c. 
Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
 
4. Other treatment: 
a. Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
b. Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
c. 
Details/Description  
 
 
 
-
-
 DD-MMM-YYYY 
 
5. Resolution of event: 
6. Reoperations 
a. Unresolved as of  
 
 
 
-
-
 DD-MMM-YYYY 
b. Resolved as of    
 
 
 
-
-
 DD-MMM-YYYY 
 
Comments: 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

Page 1 of 3 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
 
Visit Date: 
-
-
 DD-MMM-YYYY    
 
Operative Side 
Left 
Right 
Demographics 
Subject Completed Section: 
 
1. Education Level (Please choose one):  
a. 
 Less than high school 
b. 
 High school diploma 
c. 
 Greater than high school 
d. 
 Decline to answer 
 
2. Employment Status (Please choose one): 
a. 
 Working 
b. 
 Not working 
c. 
Decline to answer 
 
3. Annual household income (Please choose one): 
a. 
 > $24,999 
b. 
 $25,000-$49,999 
c. 
 $50,000-$74,999 
d. 
 $75,000-$99,999 
e. 
 $100,000-$149,999 
f. 
 > $150,000 
g. 
 Decline to answer 
 
4. Ethnicity (Please choose one): 
a. 
 Hispanic or Latino origin 
b. 
 Not Hispanic or Latino origin 
c. 
 Decline to answer 
 
5. Race (Please select all that apply): 
a. 
 American Indian or Alaskan Native 
b. 
 Asian 
c. 
 Black or African 
d. 
 Native Hawaiian or other Pacific Islander 
e. 
 White 
f. 
 Decline to answer 
 
6. Cigarette Use (Please choose one): 
a. 
 Non-smoker 
b. 
 Current cigarette smoker  
i. If current cigarette smoker specify number of packs/day and number of years. 
c. 
 Ex-cigarette smoker 
i. If former cigarette smoker specify number of packs/day and number of years and date stopped. 
d. 
 Decline to answer 
 
#Packs/day: 
     #Years: 
     Date stopped: 
-
-
 DD-MMM-YYYY    
 
7. Alcohol Use: 
a. 
 Have never used alcohol 

Page 2 of 3 
 
b. 
 Have not had alcohol in the last year 
c. 
 Less than 3 drinks a week 
d. 
 3 – 7 drinks a week 
e. 
 8 – 14 drinks a week 
f. 
 15+ drinks a week 
g. 
 Decline to answer 
 
Demographics 
Site Completed Section:  
1. Date of birth: 
-
-
 DD-MMM-YYYY 
 
2. Gender (Please choose one):  
a. 
 Male 
b. 
 Female 
3.  Select unit of measure: 
a. 
 US/English 
b. 
 Metric 
 
4. Height: 
 cm/in 
5. Weight: 
 lbs/kg 
a.  BMI 
  
 
6. Primary orthopedic diagnosis (Please choose one): 
a. 
 Osteoarthritis 
b. 
 Traumatic arthritis 
c. 
 Avascular necrosis 
d. 
 Other (specify): __________________________________ 
 
 
 
Comorbidity Component: 
 
Does the patient have any of the following conditions (Please check all that apply): 
 
 None 
 
 
 
 
 
 Myocardial infarction  
 Congestive heart failure 
 
 
 Peripheral vascular disease  
 
 Cerebrovascular disease 
 
 
 Dementia 
 
 
 
 
 Chronic pulmonary disease  
 
 Connective tissue disease 
 
 
 Peptic ulcer disease 
 Mild liver disease 
 Diabetes without organ damage 
 Diabetes with organ damage 
 Hemiplegia or paraplegia 
 Moderate or severe renal disease 
 Malignant tumor (any) 
 Leukemia 
 
 Lymphoma  
 Moderate or severe liver disease 
 Metastatic solid tumor 
 
 HIV 
 
 

Page 3 of 3 
 
 
 
 
Concurrent Medical Conditions (Please check all that apply):s 
 
None 
 
 
 
 Cancer 
 Dermatologic 
 
 
 Cardiovascular 
 Musculoskeletal 
 
 
 Digestive 
 Substance dependence 
 
 Endocrine/Metabolic 
 Urogenital 
 
 
 
 Immunologic/Lymphatic 
 Neurologic  
 
 
 Psychologic  
 
 
 
 Respiratory 
 Other (specify) 
 
 
 

Page 1 of 1 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
 
Visit Date: 
-
-
 DD-MMM-YYYY    
 
Operative Side 
Left 
Right 
Follow-up Questionnaire 
 
1. Questionnaire completed by (please choose one)?: 
a. 
 Office/clinic visit 
b. 
 Mail 
c. 
 Phone 
 
2. Do you have any pain in your knee that has the study knee replacement(Please choose one)?: 
a. 
 Yes 
i. If yes please specify:________________________________ 
b. 
 No 
c. Subject comments:____________________________ 
d. Coordinator comments:___________________________ 
 
3. Are you satisfied with the results of your study knee replacement(Please choose one)?: 
a. 
 Yes 
i. If yes please specify:________________________________ 
b. 
 No 
c. Subject comments:____________________________ 
d. Coordinator comments:___________________________ 
 
4. Have you had any surgery on your study knee since your last study required visit/contact(Please choose one)?: 
a. 
 Yes 
i. If yes please check all that answer the following 
1. Is your tibial component of your study knee still implanted(Please choose one)?: 
a. 
 Yes 
b. 
 No 
2. Is your patella component of your study knee still implanted (Please choose one)?: 
a. 
 Yes 
b. 
 No 
b. Subject comments:____________________________ 
c. Coordinator comments:___________________________ 
 
5. Height: 
 cm/in 
a. 
 Decline to answer 
 
6. Weight: 
 lbs/kg 
a. 
 Decline to answer 
 
7.  BMI 
  
 
 
 
 
Comments: 
 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
 
Visit Date: 
-
-
 DD-MMM-YYYY    
 
Operative Side 
Left 
Right 
 
Inclusion/Exclusion Form 
Inclusion Criteria 
Yes/No 
1. 
 Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form. 
a. Informed Consent Date:  
-
-
 DD-MMM-YYYY 
 
2. 
 Patient is a male or non-pregnant female age 18 – 75 years at time of study device implantation. 
 
3. 
 Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 
 
4. 
 Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella. 
 
5. 
 Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and 
rehabilitation. 
 
*All of the above must be answered “Yes” for the patient to be enrolled in the study. 
 
 
Exclusion Criteria 
Yes/No 
1. 
 Patient has a Body Mass Index (BMI) > 40. 
 
2. 
 Patient has a diagnosis of avascular necrosis or inflammatory arthritis. 
 
3. 
 Patient has an active or suspected latent infection in or about the affected knee joint at time of study device 
implantation. 
 
4. 
 Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and 
efficacy of the device. 
 
5. 
 Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget’s 
Disease) leading to progressive bone deterioration. 
 
6. 
 Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. 
> 30 days). 
 
7. 
 Patient is diagnosed with lumbar radicular pain. 
 
8. 
 Patient has a known sensitivity to device materials. 
 
9. 
 Patient is a prisoner. 
 
*All of the above must be answered “No” for the patient to be enrolled in the study. 
 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

 
© Isis Innovation Limited, 1998. All rights reserved. 
 
 
 
 
Oxford Knee Score 
(OKS) 
 
 
 
English version for the United States 

 
 
© Isis Innovation Limited, 1998. All rights reserved. Oxford Knee Score – English for the United States. 
2 / 3 
PROBLEMS WITH YOUR KNEE 
Check () one box for every question. 
 
1. During the past 4 weeks… 
 
How would you describe the pain you usually have from your knee? 
 
None 
Very mild 
Mild 
Moderate 
Severe 
 
   
 
   
 
   
 
   
 
   
 
 
2. During the past 4 weeks… 
 
Have you had any trouble with washing and drying yourself  
(all over) because of your knee? 
 
No trouble  
at all 
Very little 
trouble 
Moderate 
trouble 
Extreme 
difficulty 
Impossible  
to do 
 
   
 
   
 
   
 
   
 
   
 
 
3. During the past 4 weeks… 
 
Have you had any trouble getting in and out of a car or using public 
transportation because of your knee? (whichever you would tend to use) 
 
No trouble  
at all 
Very little 
trouble 
Moderate 
trouble 
Extreme 
difficulty 
Impossible  
to do 
 
   
 
   
 
   
 
   
 
   
 
 
4. During the past 4 weeks… 
 
For how long have you been able to walk before pain from your knee 
becomes severe? (with or without a cane) 
 
No pain/more 
than 30 
minutes 
16 to 30 
minutes 
5 to 15 
minutes 
Around the 
house only 
Not at 
all/severe 
pain when 
walking 
 
   
 
   
 
   
 
   
 
   
 
 
5. During the past 4 weeks… 
 
After a meal (sitting at a table), how painful has it been for you to stand 
up from a chair because of your knee? 
 
Not at all 
painful 
Slightly  
painful 
Moderately 
painful 
Very 
painful 
Unbearable 
 
   
 
   
 
   
 
   
 
   
 
 
6. During the past 4 weeks… 
 
Have you been limping when walking because of your knee? 
 
Rarely/ 
never 
Sometimes,  
or just at first 
Often,  
not just at 
first 
Most  
of the time 
All  
of the time 
 
   
 
   
 
   
 
   
 
   
 

 
 
© Isis Innovation Limited, 1998. All rights reserved. Oxford Knee Score – English for the United States. 
3 / 3 
 
7. During the past 4 weeks… 
 
Could you kneel down and get up again afterwards? 
 
Yes,  
easily 
With little 
difficulty 
With 
moderate 
difficulty 
With extreme 
difficulty 
No, 
impossible 
 
   
 
   
 
   
 
   
 
   
 
 
8. During the past 4 weeks… 
 
Have you been troubled by pain from your knee in bed at night? 
 
No  
nights 
Only 1 or 2 
nights 
Some 
nights 
Most 
nights 
Every 
night 
 
   
 
   
 
   
 
   
 
   
 
 
9. During the past 4 weeks… 
 
How much has pain from your knee interfered with your usual work 
(including housework)? 
 
Not at all 
A little bit 
Moderately 
Greatly 
Totally 
 
   
 
   
 
   
 
   
 
   
 
 
10. During the past 4 weeks… 
 
Have you felt that your knee might suddenly “give out” or let you down? 
 
Rarely/ 
never 
Sometimes,  
or just at first 
Often,  
not just at 
first 
Most  
of the time 
All  
of the time 
 
   
 
   
 
   
 
   
 
   
 
 
11. During the past 4 weeks… 
 
Could you do the grocery shopping on your own? 
 
Yes,  
easily 
With little 
difficulty 
With 
moderate 
difficulty 
With extreme 
difficulty 
No, 
impossible 
 
   
 
   
 
   
 
   
 
   
 
 
12. During the past 4 weeks… 
 
Could you walk down one flight of stairs? 
 
Yes,  
easily 
With little 
difficulty 
With 
moderate 
difficulty 
With extreme 
difficulty 
No, 
impossible 
 
   
 
   
 
   
 
   
 
   
 
 
 
 
Finally, please check that you have answered each question. 
 
Thank you very much. 

Appendix 2
2- Date of birth
/
/
1- Today's date
/
/
KNEE SOCIETY SCORE: POST-OP
5- Sex
Male
Female
6- Side of this (surgically treated) knee
Left
Right
Enter dates as:
mm/dd/yyyy
Page 1/7
3- Height (ft' in")
4- Weight (lbs.)
7- Ethnicity
Native Hawaiian or other Pacific Islander
Arab or Middle Eastern
Hispanic  or  Latino
American Indian or Alaska Native
African American or Black
Asian
White
If both knees have been operated on,
please use a different form for each knee
DEMOGRAPHIC INFORMATION
8- Please indicate date and surgeon for your knee replacement operation
/
/
9- Was this a primary or revision knee replacement?
Primary
Revision
Name of Surgeon
Enter dates as:
mm/dd/yyyy
Date
A
Unilateral Knee Arthritis
C1 TKR, but remote arthritis affecting ambulation
B1 Unilateral TKA, opposite knee arthritic
C2 TKR, but medical condition affecting ambulation
B2 Bilateral TKA
C3 Unilateral or Bilateral TKA with Unilateral or Bilateral THR
To be completed by surgeon
(To be completed by patient)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
10- Charnley Functional Classification
(Use Code Below)
5940547318
5940547318
5940547318
5940547318
12
Scuderi et al.
Clinical Orthopaedics and Related Research1
123

 ALIGNMENT
1- Alignment: measured on AP standing Xray(Anatomic Al
x
a
m
 t
n
i
o
p
 
5
2
 
)t
n
e
m
n
g
i
Neutral: 2-10 degrees valgus
(25 pts)
Varus: < 2 degrees valgus
(-10 pts)
Valgus: > 10 degrees valgus
(-10 pts)
Page 2/7
(To be completed by surgeon)
      INSTABILITY
2- Medial / Lateral Instability: measured in full extension
 15 point max
None
(15 pts)
Little or < 5 mm
(10 pts)
Moderate or 5 mm
  
(5 pts)
Severe or > 5 mm
(0 pts)
3- Anterior / Posterior Instability: measured at 90 degrees
        10 point max
None
(10 pts)
Moderate < 5 mm
(5 pts)
Severe > 5 mm
  
(0 pts)
OBJECTIVE KNEE INDICATORS
        JOINT MOTION
                                             
4- Range of motion (1 point for each 5 degrees)
Deductions
   
Flexion Contracture
   
  Minus Points
1-5 degrees
(-2 pts)
6-10 degrees
(-5 pts)
11-15 degrees
(-10 pts)
> 15 degrees
(-15 pts)
 
   
Extensor Lag
  
   
  Minus Points
<10 degrees
(-5 pts)
10-20 degrees
(-10 pts)
> 20 degrees
(-15 pts)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
4167547318
4167547318
4167547318
4167547318
Volume 470, Number 1, January 2012
The New Knee Society Knee Scoring System
13
123

PATIENT SATISFACTION
Page 3/7
1- Currently, how satisfied are you with the pain level of your knee while sitting?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
3- Currently, how satisfied are you with your knee function while getting out of bed?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
(To be completed by patient)
2- Currently, how satisfied are you with the pain level of your knee while lying in bed?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
4- Currently, how satisfied are you with your knee function while performing
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
light household duties?
(8 points)
(8 points)
(8 points)
(8 points)
    (8 pts)                        (6 pts)             (4 pts)            (2 pts)                   (0 pts)
Maximum total points (40 points)
SYMPTOMS
Maximum total points (25 points)
         
1- Pain with level walking
 
  (10 - Score)
0
1
2
3
4
5
6
7
8
9
10
      none
          severe
2- Pain with stairs or inclines
 
 
 (10 - Score) 
0
1
2
3
4
5
6
7
8
9
10
      none
          severe
  (5 points)
3- Does this knee feel "normal" to you?
Always (5 pts)
Sometimes (3 pts)
Never (0 pts)
5- Currently, how satisfied are you with your knee function while performing leisure
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
recreational activities?
(8 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
    (8 pts)                        (6 pts)             (4 pts)            (2 pts)                   (0 pts)
    (8 pts)                        (6 pts)             (4 pts)            (2 pts)                   (0 pts)
    (8 pts)                        (6 pts)             (4 pts)            (2 pts)                   (0 pts)
    (8 pts)                        (6 pts)             (4 pts)            (2 pts)                   (0 pts)
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Page 4/7
Compared to what you expected before your knee replacement:
1- My expectations for pain relief were...
Too High- "I'm a lot worse than I thought" (1 pt)
Too High- "I'm somewhat worse than I thought" (2 pts)
Just Right- "My expectations were met" (3 pts)
Too Low- "I'm somewhat better than I thought" (4 pts)
Too Low- "I'm a lot better than I thought" (5 pts)
2- My expectations for being able to do my normal activities of daily living were...
Too High- "I'm a lot worse than I thought" (1 pt)
Too High- "I'm somewhat worse than I thought" (2 pts)
Just Right- "My expectations were met" (3 pts)
Too Low- "I'm somewhat better than I thought" (4 pts)
Too Low- "I'm a lot better than I thought" (5 pts)
3- My expectations for being able to do my leisure, recreational or sports activities were...
Too High- "I'm a lot worse than I thought" (1 pt)
Too High- "I'm somewhat worse than I thought" (2 pts)
Just Right- "My expectations were met" (3 pts)
Too Low- "I'm somewhat better than I thought" (4 pts)
Too Low- "I'm a lot better than I thought" (5 pts)
PATIENT EXPECTATION
(5 points)
(5 points)
(5 points)
Maximum total points (15 points)
(To be completed by patient)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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123

WALKING AND STANDING  (30 points)
1 - Can you walk without any aids (such as a cane, crutches or wheelchair)?
Yes
No
2 - If no, which of the following aid(s) do you use?
wheelchair (-10 pts)
one crutch (-4 pts)
walker (-8 pts)
one cane (-4 pts)
crutches (-8 pts)
knee sleeve / brace (-2 pts)
two canes (-6 pts)
(-10 points)
other
3 - Do you use these aid(s) because of your knees?
Yes
No
4 - For how long can you stand (with or without aid) before sitting due to knee discomfort?
cannot stand (0 pts)
0-5 minutes (3 pts)
6-15 minutes (6 pts)
16-30 minutes (9 pts)
31-60 minutes (12 pts)
more than an hour (15 pts)
5 - For how long can you walk (with or without aid) before stopping due to knee discomfort?
cannot walk (0 pts)
0-5 minutes (3 pts)
6-15 minutes (6 pts)
16-30 minutes (9 pts)
31-60 minutes (12 pts)
more than an hour (15 pts)
(15 points)
(15 points)
FUNCTIONAL ACTIVITIES
Page 5/7
Maximum points (30 points)
(To be completed by patient)
(0 points)
(0 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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6 - Moving laterally (stepping
to the side)
5 - Getting into or out of a car
4 - Getting up from a low couch
or a chair without arms
3 - Climbing up or down a flight
of stairs
2 - Turning or pivoting on your
leg
1 - Walking on an uneven
surface
How much does your knee
bother you during each of the
following activities?
 no
bother
slight
moderate
severe
very
severe
I never
do this
 5            4             3            2            1             0
    cannot do
    (because
     of knee)
STANDARD  ACTIVITIES  (30 points)
5 - Running
4 - Kneeling
3 - Squatting
2 - Carrying a shopping bag for
a block
1 - Climbing a ladder or step
stool
Maximum points (25 points)
ADVANCED ACTIVITIES  (25 points)
Maximum points (30 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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Please check 3 of the activities below that you consider most
important to you.
(Please do not write in additional activities)
3.
2.
1.
        Activity
(Please write the 3 activites
from list above)
 no
bother
slight
moderate
severe
very
severe
    cannot do
    (because
     of knee)
 5              4              3               2            1              0
DISCRETIONARY KNEE ACTIVITIES  (15  points)
Page 7/7
Maximum total points (100 points)
Maximum points (15 points)
Recreational Activities
Workout and Gym Activities
Please copy all 3 checked activities into the empty boxes below.
How much does your knee bother you during each of these activities?
Swimming
Golfing (18 holes)
Road Cycling (>30mins)
Gardening
Bowling
Racquet Sports (Tennis, Racquetball, etc.)
Distance Walking
Dancing / Ballet
Stretching Exercises (stretching out your muscles)
Weight-lifting
Leg Extensions
Stair-Climber
Stationary Biking / Spinning
Leg Press
Jogging
Elliptical Trainer
Aerobic Exercises
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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Page 1 of 1 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
 
Visit Date: 
-
-
 DD-MMM-YYYY    
 
Operative Side 
Left 
Right 
Post-op Functional Evaluation 
 
1. Have there been any protocol defined Adverse Events since the last visit? Used (Please choose one): 
a. 
 Yes 
i. If yes complete AE form for each event. 
b. 
 No 
 
 
 
 
Use this section to report medical events other than protocol defined adverse events. 
 
2. Has the subject seen a doctor for any medical event since the last visit?: 
a. 
 Yes 
i. If yes please specify________________________________ 
b. 
 No 
 
3. Has the subject been hospitalized for any elective surgery since the last visit?: 
a. 
 Yes 
i. If yes please check all that apply 
ii. 
 Contralateral knee 
iii. 
 Contralateral hip 
iv. 
 Ipsilateral hip 
v. 
 Contralateral shoulder 
vi. 
 Ipsilateral shoulder 
vii. 
 Cataract 
viii. 
 Other (specify):_________________________________ 
b. 
 No 
c. Elective hospitalization details:__________________________________________________________ 
 
4. Is anything currently affecting the subject’s function?: 
a. 
 Yes 
i. If yes please specify________________________________ 
b. 
 No 
 
 
 
 
Comments: 
 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

Appendix 1
2- Date of birth
/
/
1- Today's date
/
/
KNEE SOCIETY SCORE: PRE-OP
5- Sex
Male
Female
6- Side of this (symptomatic) knee
Left
Right
Enter dates as:
mm/dd/yyyy
Page 1/7
3- Height (ft' in")
4- Weight (lbs.)
7- Ethnicity
Native Hawaiian or other Pacific Islander
Arab or Middle Eastern
Hispanic  or  Latino
American Indian or Alaska Native
African American or Black
Asian
White
If both knees will be operated on, please
use a different form for each knee
DEMOGRAPHIC INFORMATION
8- Please indicate the expected date and surgeon for your knee replacement operation
/
/
9- Will this be a primary or revision knee replacement?
Primary
Revision
Name of Surgeon
Enter dates as:
mm/dd/yyyy
Date
To be completed by surgeon
(To be completed by patient)
A
Unilateral Knee Arthritis
C1 TKR, but remote arthritis affecting ambulation
B1 Unilateral TKA, opposite knee arthritic
C2 TKR, but medical condition affecting ambulation
B2 Bilateral TKA
C3 Unilateral or Bilateral TKA with Unilateral or Bilateral THR
10- Charnley Functional Classification
(Use Code Below)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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        JOINT MOTION
                                             
4- Range of motion (1 point for each 5 degrees)
Deductions
   
Flexion Contracture
   
  Minus Points
1-5 degrees
(-2 pts)
6-10 degrees
(-5 pts)
11-15 degrees
(-10 pts)
> 15 degrees
(-15 pts)
 
   
Extensor Lag
  
   
  Minus Points
<10 degrees
(-5 pts)
10-20 degrees
(-10 pts)
> 20 degrees
(-15 pts)
 ALIGNMENT
1- Alignment: measured on AP standing Xray(Anatomic Al
x
a
m
 t
n
i
o
p
 
5
2
  
)t
n
e
m
n
g
i
Neutral: 2-10 degrees valgus
(25 pts)
Varus: < 2 degrees valgus
(-10 pts)
Valgus: > 10 degrees valgus
(-10 pts)
Page 2/7
(To be completed by surgeon)
      INSTABILITY
2- Medial / Lateral Instability: measured in full extension
 15 point max
None
(15 pts)
Little or < 5 mm
(10 pts)
Moderate or 5 mm
  
(5 pts)
Severe or > 5 mm
(0 pts)
3- Anterior / Posterior Instability: measured at 90 degrees
        10 point max
None
(10 pts)
Moderate < 5 mm
(5 pts)
Severe > 5 mm
  
(0 pts)
OBJECTIVE KNEE INDICATORS
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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PATIENT SATISFACTION
Page 3/7
1- Currently, how satisfied are you with the pain level of your knee while sitting?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
3- Currently, how satisfied are you with your knee function while getting out of bed?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
(To be completed by patient)
2- Currently, how satisfied are you with the pain level of your knee while lying in bed?
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
4- Currently, how satisfied are you with your knee function while performing
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
light household duties?
(8 points)
(8 points)
(8 points)
(8 points)
    (8 pts)                      (6 pts)             (4 pts)           (2 pts)                 (0 pts)
    (8 pts)                      (6 pts)             (4 pts)           (2 pts)                 (0 pts)
    (8 pts)                      (6 pts)             (4 pts)           (2 pts)                 (0 pts)
    (8 pts)                      (6 pts)             (4 pts)           (2 pts)                 (0 pts)
Maximum total points (40 points)
SYMPTOMS
Maximum total points (25 points)
         
1- Pain with level walking
 
  (10 - Score)
0
1
2
3
4
5
6
7
8
9
10
      none
          severe
2- Pain with stairs or inclines
  
 
(10 - Score) 
0
1
2
3
4
5
6
7
8
9
10
      none
          severe
  (5 points)
3- Does this knee feel "normal" to you?
Always (5 pts)
Sometimes (3 pts)
Never (0 pts)
5- Currently, how satisfied are you with your knee function while performing leisure
Very  Satisfied
Satisfied
Neutral
Dissatisfied
Very  Dissatisfied
recreational activities?
(8 points)
    (8 pts)                      (6 pts)             (4 pts)           (2 pts)                 (0 pts)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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Page 4/7
What do you expect to accomplish with your knee replacement:
1- Do you expect your knee joint replacement surgery will relieve your knee pain?
no, not at all (1 pt)
yes, a little bit (2 pts)
yes, somewhat (3 pts)
yes, a moderate amount (4 pts)
yes, a lot (5 pts)
2- Do you expect your surgery will help you carry out your normal activities of daily living?
no, not at all (1 pt)
yes, a little bit (2 pts)
yes, somewhat (3 pts)
yes, a moderate amount (4 pts)
yes, a lot (5 pts)
3- Do you expect you surgery will help you perform leisure, recreational or sports activities?
no, not at all (1 pt)
yes, a little bit (2 pts)
yes, somewhat (3 pts)
yes, a moderate amount (4 pts)
yes, a lot (5 pts)
PATIENT EXPECTATIONS
(5 points)
Maximum total points (15 points)
(To be completed by patient)
(5 points)
(5 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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WALKING AND STANDING  (30 points)
1 - Can you walk without any aids (such as a cane, crutches or wheelchair)?
Yes
No
2 - If no, which of the following aid(s) do you use?
wheelchair (-10 pts)
one crutch (-4 pts)
walker (-8 pts)
one cane (-4 pts)
crutches (-8 pts)
knee sleeve / brace (-2 pts)
two canes (-6 pts)
(-10 points)
other
3 - Do you use these aid(s) because of your knees?
Yes
No
4 - For how long can you stand (with or without aid) before sitting due to knee discomfort?
cannot stand (0 pts)
0-5 minutes (3 pts)
6-15 minutes (6 pts)
16-30 minutes (9 pts)
31-60 minutes (12 pts)
more than an hour (15 pts)
5 - For how long can you walk (with or without aid) before stopping due to knee discomfort?
cannot walk (0 pts)
0-5 minutes (3 pts)
6-15 minutes (6 pts)
16-30 minutes (9 pts)
31-60 minutes (12 pts)
more than an hour (15 pts)
(15 points)
(15 points)
FUNCTIONAL ACTIVITIES
Page 5/7
Maximum points (30 points)
(To be completed by patient)
(0 points)
(0 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
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Page 6/7
How much does your knee
bother you during each of the
following activities?
 no
bother
slight
moderate
severe
very
severe
I never
do this
 5            4             3            2            1             0
    cannot do
    (because
     of knee)
STANDARD  ACTIVITIES  (30 points)
Maximum points (25 points)
ADVANCED ACTIVITIES  (25 points)
Maximum points (30 points)
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
1 - Walking on an uneven
surface
2 - Turning or pivoting on your
leg
3 - Climbing up or down a flight
of stairs
4 - Getting up from a low couch
or a chair without arms
5 - Getting into or out of a car
6 - Moving laterally (stepping
to the side)
1 - Climbing a ladder or step
stool
2 - Carrying a shopping bag for
a block
3 - Squatting
4 - Kneeling
5 - Running
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Please check 3 of the activities below that you consider most
important to you.
(Please do not write in additional activities)
3.
2.
1.
        Activity
(Please write the 3 activites
from list above)
 no
bother
slight
moderate
severe
very
severe
    cannot do
    (because
     of knee)
 5              4              3               2            1              0
DISCRETIONARY KNEE ACTIVITIES  (15  points)
Page 7/7
Maximum total points (100 points)
Maximum points (15 points)
Recreational Activities
Workout and Gym Activities
Please copy all 3 checked activities into the empty boxes below.
How much does your knee bother you during each of these activities?
Swimming
Golfing (18 holes)
Road Cycling (>30mins)
Gardening
Bowling
Racquet Sports (Tennis, Racquetball, etc.)
Distance Walking
Dancing / Ballet
Stretching Exercises (stretching out your muscles)
Weight-lifting
Leg Extensions
Stair-Climber
Stationary Biking / Spinning
Leg Press
Jogging
Elliptical Trainer
Aerobic Exercises
© 2011 by The Knee Society. All rights reserved. No part of this document may be reproduced or transmitted in any form or by
any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of The Knee Society.
7470569402
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SF-12v2® Health Survey  1994, 2002 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-12® is a registered trademark of Medical Outcomes Trust. 
 
(SF-12v2® Health Survey Standard, United States (English)) 
 
 
Your Health and Well-Being 
 
 
This survey asks for your views about your health. This information will help 
keep track of how you feel and how well you are able to do your usual activities. 
Thank you for completing this survey! 
 
For each of the following questions, please mark an 
 in the one box that best 
describes your answer. 
 
1. In general, would you say your health is: 
2. The following questions are about activities you might do during a typical 
day.  Does your health now limit you in these activities?  If so, how much? 
 
Yes, 
limited 
a lot 
Yes, 
limited 
a little 
No, not 
limited 
at all 
 
   
 
a Moderate activities, such as moving a table, pushing  
a vacuum cleaner, bowling, or playing golf.............................
 1..............
 2.............
 3 
 
b Climbing several flights of stairs.............................................
 1..............
 2.............
 3 
Excellent 
Very good 
Good 
Fair 
Poor 
 

 

 
  
 1 
  
 2 
  
 3 
  
 4 
  
 5 

SF-12v2® Health Survey  1994, 2002 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-12® is a registered trademark of Medical Outcomes Trust. 
 
(SF-12v2® Health Survey Standard, United States (English)) 
3. During the past 4 weeks, how much of the time have you had any of the 
following problems with your work or other regular daily activities as a 
result of your physical health?  
4. During the past 4 weeks, how much of the time have you had any of the 
following problems with your work or other regular daily activities as a 
result of any emotional problems (such as feeling depressed or anxious)? 
5. During the past 4 weeks, how much did pain interfere with your normal 
work (including both work outside the home and housework)?  
Not at all 
A little bit 
Moderately 
Quite a bit 
Extremely 
 

 

 
  
 1 
  
 2 
  
 3 
  
 4 
  
 5 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
   
 
a 
Accomplished less than you  
 
 
would like......................................
 1.............
 2..............
 3..............
 4.............
 5 
 
b 
Were limited in the kind of  
 
 
work or other activities..................
 1.............
 2..............
 3..............
 4.............
 5
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
   
 
a 
Accomplished less than you  
 
 
would like......................................
 1.............
 2..............
 3..............
 4.............
 5 
 
b 
Did work or other activities 
 
 
less carefully than usual ................
 1.............
 2..............
 3..............
 4.............
 5

SF-12v2® Health Survey  1994, 2002 Medical Outcomes Trust and QualityMetric Incorporated.  All rights reserved. 
SF-12® is a registered trademark of Medical Outcomes Trust. 
 
(SF-12v2® Health Survey Standard, United States (English)) 
6. These questions are about how you feel and how things have been with you 
during the past 4 weeks.  For each question, please give the one answer that 
comes closest to the way you have been feeling.  How much of the time 
during the past 4 weeks… 
7. During the past 4 weeks, how much of the time has your physical health or 
emotional problems interfered with your social activities (like visiting with 
friends, relatives, etc.)? 
 
 
 
 
 
 
 
Thank you for completing these questions! 
 
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 
 
 
 
 
a 
Have you felt calm and   
peaceful?........................................
 1..............
 2..............
 3..............
 4..............
 5 
 
b 
Did you have a lot of energy? .......
 1..............
 2..............
 3..............
 4..............
 5 
 
c 
Have you felt downhearted   
and depressed?...............................
 1..............
 2..............
 3..............
 4..............
 5
All of 
the time 
Most of 
the time 
Some of 
the time 
A little of 
the time 
None of 
the time 
 

 

 
  
 1 
  
 2
 
3
 
4
  
 5 

Page 1 of 3 
 
Stryker 
®
 
Triathlon Tritanium Knee Study 
Patient ID:  74 - 
 - 
 
Patient Initials (if there’s no middle initial please use a “-“) 
 
Visit Date: 
-
-
 DD-MMM-YYYY    
Operative Side 
Left 
Right 
Surgical Details 
 
1. Type of Anesthesia Used (Please check all that apply):  
a. 
 General 
b. 
 Spinal 
c. 
 Epidural 
d. 
 Femoral Block 
e. 
 Not recorded 
 
2. ASA Score (Please choose one): 
a. 
 ASA 1 
b. 
 ASA 2 
c. 
 ASA 3 
d. 
 ASA 4 
e. 
 ASA 5 
f. 
 Not recorded 
 
3. Surgical Approach (Please choose one): 
a. 
 Medial Parapatellar 
b. 
 Lateral Parapatellar 
c. 
 Sub Vastus 
d. 
 Mid Vastus 
 
4. Navigation Used (Please choose one): 
a. 
 Yes 
b. 
 No 
 
5. Femoral Instrumentation Referencing (Please choose one): 
a. 
 Anterior Referencing 
b. 
 Posterior Referencing 
 
6. Femoral Instrumentation Alignment (Please choose one): 
a. 
 Internal Alignment 
b. 
 External Alignment 
c. 
 Not recorded 
 
7. Tibial Instrumentation Referencing (Please choose one): 
a. 
 Internal Alignment 
b. 
 External Alignment 
c. 
 Not recorded 
 
8. Bone removed (Please complete for each): 
a. Distal Femur: 
mm  
i. 
 Not recorded 
b. Proximal Femur: 
mm 
i. 
 Not recorded 
 
9. Estimated blood loss 
a. 
 
cc’s  
i. 
 Not recorded 
 
10. Units of blood transfused 
a. 
 
cc’s  
i. 
 Not recorded 
 
 

Page 2 of 3 
 
11. Skin to skin time 
a. 
 
minutes  
i. 
 Not recorded 
 
12. Tourniquet time 
a. 
 
minutes  
i. 
 Not recorded 
 
13. Soft tissue released (Please check all that apply): 
 
None  
 
 
 
 Lateral head of gastrocnemius 
 Illiotibial tract  
 
 
 Medial collateral ligament 
 Parapatellar  
 
 
 Lateral retinacular 
 Popliteus tendon 
 
 
 Posterior cruciate ligament 
 Poster-lateral capsule  
 
 Posterior medial capsule 
 Lateral collateral ligament 
 
 Other (specify) 
 Bicep femoris tendon  
 
 Not recorded 
 Peptic ulcer disease  
 
 
 
14. Intraoperative complication (Please choose one): 
a. 
 Yes 
b. 
 No 
 
15. Antibiotic prophylaxis used (Please choose one): 
a. 
 Yes 
i. If yes please specify type________________________________ 
b. 
 No 
 
16. Blood loss prophylaxis used (Please choose one): 
a. 
 Yes 
i. If yes please specify type________________________________ 
b. 
 No 
 
 
17. How satisfied are you with the initial fixation? (Please choose one): 
a. 
 Extremely 
b. 
 Quite a bit 
c. 
 Moderately 
d. 
 A little bit  
e. 
 Not at all 
 
18. Discharge Date: 
-
-
 DD-MMM-YYYY    
 
19. Discharged to (Please choose one):  
a. 
 Skilled nursing facility 
b. 
 Chronic care center 
c. 
 Rehabilitation unit 
d. 
 Home 
e. 
 Other (specify) 
f. 
 Not recorded 
 
20. Post-op plan (Please choose one):  
a. 
 Full weight bearing 
b. 
 Partial weight bearing 
c. 
 Not recorded 
 
 
Component Listing: 
 
Femoral Component: Reference# and Lot#,  Tibial Component/ Metal Tray: Reference# and Lot#, Tibial Insert/ UHMWPE 
Bearing: Reference# and Lot# and Patellar Component: Reference# and Lot# 
 
 

Page 3 of 3 
 
 
Comments: 
Investigator signature:________________ Date: 
-
-
 DD-MMM-YYYY    

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix G 
 
Product Labeling 
 

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Print Date: Dec 12, 2013 21:25:41 GMT


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!QIN4419 REV A.indd   25
4/8/2013   1:07:24 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


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!QIN4419 REV A.indd   26
4/8/2013   1:07:24 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


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!QIN4419 REV A.indd   27
4/8/2013   1:07:24 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   31
4/8/2013   1:07:25 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   32
4/8/2013   1:07:25 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   33
4/8/2013   1:07:25 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   43
4/8/2013   1:07:25 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   44
4/8/2013   1:07:25 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   56
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   57
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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Print Date: Dec 12, 2013 21:25:41 GMT

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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   67
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   68
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ĲȘȢȐȡșȡȦıȘȢȖȠȞȐĲȠȣȉĮȤĮȡĮțĲȘȡȚıĲȚțȐʌȠȣİȓȞĮȚıȣȖțİțȡȚȝȑȞĮȖȚĮțȐșİıȣıțİȣȒʌİȡȚȖȡȐĳȠȞĲĮȚ
ȜİʌĲȠȝİȡȫȢıĲȘȞİĲȚțȑĲĮĲȠȣʌȡȠȧȩȞĲȠȢǾǺȐıȘȆȜȐțĮȢ7ULDWKORQ7ULWDQLXPİȞįİȓțȞȣĲĮȚĲȩıȠȖȚĮİĳĮȡȝȠȖȑȢ
ȝİĲıȚȝȑȞĲȠȩıȠțĮȚȖȚĮİĳĮȡȝȠȖȑȢȤȦȡȓȢĲıȚȝȑȞĲȠ
ȂȘȡȚĮȓĮȈĲİȜȑȤȘǾǺȐıȘȆȜȐțĮȢ7ULDWKORQ7ULWDQLXPİȓȞĮȚıȣȝȕĮĲȒȝİĲĮıȤȑįȚĮȤȚĮıĲȒȢıȣȖțȡȐĲȘıȘȢ
7ULDWKORQ&5țĮȚȤȚĮıĲȒȢıĲȑȡȘıȘȢȠʌȓıșȚĮıĲĮșİȡȠʌȠȓȘıȘ±36
ȀȞȘȝȚĮȓĮȈĲİȜȑȤȘǾǺȐıȘȆȜȐțĮȢ7ULDWKORQ7ULWDQLXPİȓȞĮȚıȣȝȕĮĲȒȝİĲĮıȤȑįȚĮțȞȘȝȚĮȓȦȞȑȞșİĲȦȞıİ
ȤȚĮıĲȒıȣȖțȡȐĲȘıȘ&5ȠʌȓıșȚĮȢıĲĮșİȡȠʌȠȓȘıȘȢ36țĮȚțȠȞįȣȜȚțȒȢıĲĮșİȡȠʌȠȓȘıȘȢ&6ȉĮțȞȘȝĮȓĮ
ȑȞșİĲĮįȚĮșȑĲȠȞĲĮȚıİİȪȡȠȢʌȐȤȠȣȢțĮȚıİįȚȐĳȠȡȠȣȢȕĮșȝȠȪȢıȣȖțȡȐĲȘıȘȢ
ȈȘȝİȓȦıȘǾǺȐıȘȆȜȐțĮȢ7ULDWKORQ7ULWDQLXPȑȤİȚıȣıțİȣĮıĲİȓȝĮȗȓȝİǼʌȓșİȝĮȆȡȠıțȡȠȣıĲȒȡĮȉȠ
ǼʌȓșİȝĮȆȡȠıțȡȠȣıĲȒȡĮʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚȘșİȓȝȩȞȠțĮĲȐĲȘįȚȐȡțİȚĮĲȠȣȕȒȝĮĲȠȢʌȡȩıțȡȠȣıȘȢ
ıĲȘțȞȘȝȚĮȓĮȕȐıȘʌȜȐțĮȢțĮȚʌȡȑʌİȚȞĮĮʌȠȡȡȚĳșİȓĮĳȩĲȠȣȠȜȠțȜȘȡȦșİȓȘʌȡȩıțȡȠȣıȘȉȠǼʌȓșİȝĮ
ȆȡȠıțȡȠȣĲȒȡĮįİȞİȞįİȓțȞȣĲĮȚȖȚĮİȝĳȪĲİȣıȘ
ǼʌȚȖȠȞĮĲȚįȚțȐȈĲİȜȑȤȘȉĮıĲİȜȑȤȘİʌȚȖȠȞĮĲȚįȚțȒȢİʌĮȞȩȡșȦıȘȢįȚĮĲȓșİȞĲĮȚıİıȤȑįȚĮʌȠȣİȓȞĮȚıȣȝȝİĲȡȚțȐ
țĮȚĮıȪȝȝİĲȡĮțĮȚİȟȠȜȠțȜȒȡȠȣʌȜĮıĲȚțȐțĮȚıİıȤȑįȚĮȝİȝİĲĮȜȜȚțȒʌȜȐĲȘǾȤȡȒıȘİʌȚȖȠȞĮĲȚįȚțȫȞıĲİȜİȤȫȞ
İȓȞĮȚʌȡȠĮȚȡİĲȚțȒǾǺȐıȘȆȜȐțĮȢ7ULDWKORQ7ULWDQLXPİȓȞĮȚıȣȝȕĮĲȒȝİȩȜĮĲĮİʌȚȖȠȞĮĲȚįȚțȐıĲİȜȑȤȘ
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ȀȞȘȝȚĮȓĮȑȞșİĲĮıĲȒȡȚȟȘȢİʌȚȖȠȞĮĲȚįȚțȐıĲİȜȑȤȘ
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ȞĮİʌĮȞĮĳİȡșȠȪȞıİİʌĮȡțȒȜİȚĲȠȣȡȖȓĮțĮȚıĲĮșİȡȩĲȘĲĮ
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ĬȜȐıȘĲȠȣʌİȡȚĳİȡȚțȠȪȝȘȡȠȪȒțĮȚĲȘȢİȖȖȪȢțȞȒȝȘȢʌȠȣįİȞįȪȞĮĲĮȚȞĮıĲĮșİȡȠʌȠȚȘșİȓȝİĲȣʌȚțȑȢ
ĲİȤȞȚțȑȢįȚĮȤİȓȡȚıȘȢșȜȐıȘȢ
ǿǻȑĲșȇȝȑȜįȣ7ULDWKORQ7ULWDQLXPıȟİıȔȜȟȤĳįțĳȪĲȡȗțįȥȢȓĲșȞıĳĲțȞȒȟĳȡȪĲȡȜįțȗțįȥȢȓĲșȥȧȢȔȣ
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!QIN4419 REV A.indd   72
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ȈȣȝʌȜȘȡȦȝĮĲȚțȑȢİȞįİȓȟİȚȢȖȚĮıĲİȜȑȤȘȝİȅʌȓıșȚĮȈĲĮșİȡȠʌȠȓȘıȘ36
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șȜȐıȘȢȒțĮȚĳșȠȡȐȢĲȦȞİȝĳȣĲİȣȝȐĲȦȞʌȡȩșİıȘȢǾȤĮȜȐȡȦıȘĲȦȞıĲİȜİȤȫȞȝʌȠȡİȓȞĮȑȤİȚȦȢ
ĮʌȠĲȑȜİıȝĮĮȣȟĮȞȩȝİȞȘʌĮȡĮȖȦȖȒĲȦȞȝȠȡȓȦȞĳșȠȡȐȢțĮșȫȢțĮȚȕȜȐȕȘıĲȠȠıĲȩțĮșȚıĲȫȞĲĮȢ
įȪıțȠȜȘĲȘȞİʌȚĲȣȤȒİʌȑȝȕĮıȘĮȞĮșİȫȡȘıȘȢ
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ȅȚȤİȚȡȠȣȡȖȠȓșĮʌȡȑʌİȚȞĮʌȡȠİȚįȠʌȠȚȒıȠȣȞĲȠȣȢĮıșİȞİȓȢȞĮʌİȡȚȠȡȓıȠȣȞĲȚȢįȡĮıĲȘȡȚȩĲȘĲİȢțĮȚȞĮ
ʌȡȠıĲĮĲİȪıȠȣȞĲȘȞȐȡșȡȦıȘʌȠȣĮȞĲȚțĮșȓıĲĮĲĮȚĮʌȩȣʌİȡȕȠȜȚțȑȢĲȐıİȚȢțĮȚȞĮĲȘȡȒıȠȣȞĲȚȢȠįȘȖȓİȢ
ĲȠȣȚĮĲȡȠȪȩıȠȞĮĳȠȡȐĲȘȞİʌĮțȩȜȠȣșȘĳȡȠȞĲȓįĮțĮȚșİȡĮʌİȓĮ
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ȅȚȤİȚȡȠȣȡȖȠȓʌȡȑʌİȚȞĮʌȡȠİȚįȠʌȠȚȠȪȞĲȠȣȢĮıșİȞİȓȢıȤİĲȚțȐȝİĲȚȢʌȚșĮȞȑȢʌĮȡİȞȑȡȖİȚİȢ
ıȣȝʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢțĮȚĲȘȢʌİȡȚȠȡȚıȝȑȞȘȢįȚȐȡțİȚĮȢĲȘȢıȣıțİȣȒȢțĮȚĲȘȞĮȞȐȖțȘȖȚĮĲȘȞ
ȝİĲİȖȤİȚȡȘĲȚțȒʌȡȠıĲĮıȓĮĲȠȣİȝĳȣĲİȪȝĮĲȠȢȅȤİȚȡȠȣȡȖȩȢʌȡȑʌİȚȞĮʌȡȠİȚįȠʌȠȚİȓĲȠȣȢĮıșİȞİȓȢȩĲȚ
ȘıȣıțİȣȒįİȞĮȞĲȚțĮșȚıĲȐĲȘȞİȣȜȣȖȚıȓĮȚıȤȪĮȟȚȠʌȚȠıĲȓĮȒĮȞșİțĲȚțȩĲȘĲĮȝȚĮȢĳȣıȚȠȜȠȖȚțȒȢȣȖȚȒȢ
ȐȡșȡȦıȘȢțĮȚȩĲȚĲȠİȝĳȪĲİȣȝĮİȞįȑȤİĲĮȚȞĮıʌȐıİȚȒȞĮȣʌȠıĲİȓȕȜȐȕȘȫȢĮʌȠĲȑȜİıȝĮİʌȓʌȠȞȘȢ
įȡĮıĲȘȡȚȩĲȘĲĮȢȒĲȡĮȪȝĮĲȠȢ
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ǾțĮĲȐȜȜȘȜȘİʌȚȜȠȖȒĲȠʌȠșȑĲȘıȘțĮȚıĲİȡȑȦıȘĲȦȞıĲİȜİȤȫȞȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢİȓȞĮȚ
țȡȓıȚȝȠȚʌĮȡȐȖȠȞĲİȢʌȠȣİʌȘȡİȐȗȠȣȞĲȘįȚȐȡțİȚĮȗȦȒȢĲȠȣİȝĳȣĲİȪȝĮĲȠȢǵʌȦȢțĮȚıĲȘȞʌİȡȓʌĲȦıȘ
ȩȜȦȞĲȦȞʌȡȩıșİĲȦȞİȝĳȣĲİȣȝȐĲȦȞȘĮȞĲȠȤȒĮȣĲȫȞĲȦȞıĲİȜİȤȫȞİʌȘȡİȐȗİĲĮȚĮʌȩįȚȐĳȠȡȠȣȢ
ȕȚȠȜȠȖȚțȠȪȢȕȚȠȝȘȤĮȞȚțȠȪȢțĮȚȐȜȜȠȣȢİȟȦĲİȡȚțȠȪȢʌĮȡȐȖȠȞĲİȢȠȚȠʌȠȓȠȚİʌȘȡİȐȗȠȣȞĲȘįȚȐȡțİȚĮ
ȗȦȒȢĲȠȣȢīȚĮĲȠȜȩȖȠĮȣĲȩĮʌĮȚĲİȓĲĮȚȞĮĮțȠȜȠȣșȘșȠȪȞʌȚıĲȐȠȚİȞįİȓȟİȚȢĮȞĲİȞįİȓȟİȚȢʌȡȠĳȣȜȐȟİȚȢ
țĮȚʌȡȠİȚįȠʌȠȚȒıİȚȢĮȣĲȠȪĲȠȣʌȡȠȧȩȞĲȠȢʌȡȠțİȚȝȑȞȠȣȞĮİʌȚĲİȣȤșİȓȘȝȑȖȚıĲȘįȚȐȡțİȚĮȗȦȒȢĲȠȣ
ȌȢȓĲșȜįțıȞĴȫĳıȤĲș
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ȋȡȘıȚȝȠʌȠȚȒıĲİĲĮıȣȞȚıĲȫȝİȞĮıĲİȜȑȤȘȖȚĮĲȠȞțĮșȠȡȚıȝȩȝİȖȑșȠȣȢĲȘȝİȓȦıȘįȠțȚȝȒȢțĮȚĲȘȞ
ĮȟȚȠȜȩȖȘıȘİȪȡȠȣȢțȓȞȘıȘȢįȚĮĲȘȡȫȞĲĮȢȑĲıȚĲȘȞĮțİȡĮȚȩĲȘĲĮĲȦȞʌȡĮȖȝĮĲȚțȫȞİȝĳȣĲİȣȝȐĲȦȞțĮȚĲȘȞ
ĮʌȠıĲİȚȡȦȝȑȞȘıȣıțİȣĮıȓĮĲȠȣȢ
!QIN4419 REV A.indd   73
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ĬĮʌȡȑʌİȚȞĮįȠșİȓʌȡȠıȠȤȒȖȚĮȞĮĮĳĮȚȡİșȠȪȞĲĮȠıĲȚțȐțȠȝȝĮĲȐțȚĮĲİȝȐȤȚĮȠıĲȚțȠȪĲıȚȝȑȞĲȠȣțĮȚ
ĲĮȝİĲĮȜȜȚțȐȣʌȠȜİȓȝȝĮĲĮĮʌȩĲȘȞʌİȡȚȠȤȒİȝĳȪĲİȣıȘȢʌȡȠȢȝİȓȦıȘĲȘȢİʌȚĲĮȤȣȞȩȝİȞȘȢĳșȠȡȐȢĲȘȢ
ĮȡșȡȦĲȒȢʌȡȩșİıȘȢĲȠȣİȝĳȣĲİȪȝĮĲȠȢʌȠȣʌȡȠțȪʌĲİȚĮʌȩĲĮȣʌȠȜİȚȝȝȐĲĮʌȠȣʌĮȡȐȖȠȞĲĮȚ
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ȉĮȋİȚȡȠȣȡȖȚțȐȆȡȦĲȩțȠȜȜĮĲȘȢ+RZPHGLFD2VWHRQLFV&RUSȆĮȡȑȤȠȣȞıȣȝʌȜȘȡȦȝĮĲȚțȑȢ
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ȈȣȝȕȠȣȜİȣșİȓĲİĲȘȞİĲȚțȑĲĮĲȠȣʌȡȠȧȩȞĲȠȢıȤİĲȚțȐȝİĲȘıȣȖțİțȡȚȝȑȞȘıȣȝȕĮĲȩĲȘĲĮĲȠȣʌȡȠȧȩȞĲȠȢ
īİȞȚțȐȚıȤȪȠȣȞĲĮĮțȩȜȠȣșĮ
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ȅȤİȚȡȠȣȡȖȩȢșĮʌȡȑʌİȚȞĮįȫıİȚıȣȝȕȠȣȜȑȢıĲȠȞĮıșİȞȒȖȚĮĲȠȣȢʌİȡȚȠȡȚıȝȠȪȢĲȘȢİʌĮȞȩȡșȦıȘȢ
țĮȚĲȘȞĮȞȐȖțȘʌȡȠıĲĮıȓĮȢĮʌȩʌȜȒȡȘĳȩȡĲȚıȘȕȐȡȠȣȢȝȑȤȡȚȢȩĲȠȣİʌȑȜșİȚİʌĮȡțȒȢıĲĮșİȡȠʌȠȓȘıȘ
țĮȚȓĮıȘǾȣʌİȡȕȠȜȚțȒįȡĮıĲȘȡȚȩĲȘĲĮțĮȚĲȠĲȡĮȪȝĮʌȠȣİʌȘȡİȐȗȠȣȞĲȘȞĮȞĲȚțĮĲȐıĲĮıȘȐȡșȡȦıȘȢ
ĮʌȠĲİȜȠȪȞȝȑȡȠȢĲȘȢĮʌȠĲȣȤȓĮȢĲȘȢİʌĮȞȩȡșȦıȘȢȜȩȖȦȤĮȜȐȡȦıȘȢșȡĮȪıȘȢȒțĮȚĳșȠȡȐȢĲȦȞ
ʌȡȠıșİĲȚțȫȞİȝĳȣĲİȣȝȐĲȦȞǾȤĮȜȐȡȦıȘĲȦȞıĲȠȚȤİȓȦȞȝʌȠȡİȓȞĮȑȤİȚȦȢĮʌȠĲȑȜİıȝĮĮȣȟȘȝȑȞȘ
ʌĮȡĮȖȦȖȒıȦȝĮĲȚįȓȦȞʌȠȣʌȡȠțĮȜȠȪȞĳșȠȡȐțĮșȫȢțĮȚȕȜȐȕȘıĲȠȠıĲȩțĮșȚıĲȫȞĲĮȢʌȚȠįȪıțȠȜȘ
ĲȘȞİʌȚĲȣȤȒİʌȑȝȕĮıȘĮȞĮșİȫȡȘıȘȢ
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ȅȤİȚȡȠȣȡȖȩȢșĮʌȡȑʌİȚȞĮıȣȝȕȠȣȜİȪıİȚĲȠȞĮıșİȞȒȞĮʌİȡȚȠȡȓıİȚĲȚȢįȡĮıĲȘȡȚȩĲȘĲİȢțĮȚȞĮ
ʌȡȠıĲĮĲİȪıİȚĲȘȞȐȡșȡȦıȘĮʌȩʌĮȡȐȜȠȖȘĲȐıȘțĮȚȞĮĲȘȡȒıİȚĲȚȢȠįȘȖȓİȢĲȠȣȚĮĲȡȠȪıȤİĲȚțȐȝİĲȘ
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ȅȤİȚȡȠȣȡȖȩȢșĮʌȡȑʌİȚȞĮʌȡȠİȚįȠʌȠȚȒıİȚĲȠȞĮıșİȞȒıȤİĲȚțȐȝİĲȠȣȢțȚȞįȪȞȠȣȢĲȘȢİȖȤİȓȡȘıȘȢțĮȚ
ĲȚȢʌȚșĮȞȑȢʌĮȡİȞȑȡȖİȚİȢȅȤİȚȡȠȣȡȖȩȢșĮʌȡȑʌİȚȞĮʌȡȠİȚįȠʌȠȚȒıİȚĲȠȞĮıșİȞȒȩĲȚȘıȣıțİȣȒįİȞ
ĮȞĲȚțĮșȚıĲȐȝȚĮĳȣıȚȠȜȠȖȚțȒȣȖȚȒȐȡșȡȦıȘȩĲȚĲȠİȝĳȪĲİȣȝĮȝʌȠȡİȓȞĮıʌȐıİȚȒȞĮțĮĲĮıĲȡĮĳİȓȦȢ
ĮʌȠĲȑȜİıȝĮȣʌİȡȕȠȜȚțȒȢįȡĮıĲȘȡȚȩĲȘĲĮȢȒĲȡĮȪȝĮĲȠȢțĮȚȩĲȚȘıȣıțİȣȒȑȤİȚȠȡȚıȝȑȞȘįȚȐȡțİȚĮȗȦȒȢ
țĮȚȝʌȠȡİȓȞĮȤȡİȚĮıĲİȓȞĮĮȞĲȚțĮĲĮıĲĮșİȓıĲȠȝȑȜȜȠȞ
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ȈĲȘȞțĮșȘȝİȡȚȞȒȗȦȒȝʌȠȡİȓȞĮİȝĳĮȞȚıĲİȓʌĮȡȠįȚțȒȪʌĮȡȟȘȕĮțĲȘȡȓȦȞıĲȠĮȓȝĮȅįȠȞĲȚĮĲȡȚțȑȢ
İʌİȝȕȐıİȚȢİȞįȠıțȠʌȚțȑȢİȟİĲȐıİȚȢțĮȚȐȜȜİȢįİȣĲİȡİȪȠȣıĮȢıȘȝĮıȓĮȢȤİȚȡȠȣȡȖȚțȑȢİʌİȝȕȐıİȚȢȑȤȠȣȞ
İʌȓıȘȢıȣȞįİșİȓȝİĲȘȞʌĮȡȠįȚțȒȪʌĮȡȟȘȕĮțĲȘȡȓȦȞıĲȠĮȓȝĮīȚĮȞĮĮʌȠĳİȪȖȠȞĲĮȚȝȠȜȪȞıİȚȢıĲĮ
ıȘȝİȓĮİȝĳȪĲİȣıȘȢȓıȦȢʌȡȑʌİȚȞĮȜĮȝȕȐȞİĲĮȚĮȞĲȚȕȚȠĲȚțȒʌȡȠĳȪȜĮȟȘʌȡȚȞțĮȚȝİĲȐĮʌȩİʌİȝȕȐıİȚȢ
ĮȣĲȠȪĲȠȣİȓįȠȣȢ
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ǹʌȠȡȡȓȥĲİȩȜĮĲĮțĮĲİıĲȡĮȝȝȑȞĮİȝĳȣĲİȪȝĮĲĮȒĲĮİȝĳȣĲİȪȝĮĲĮʌȠȣȑȤȠȣȞĲİșİȓȣʌȩȐıȤȘȝȘ
ȝİĲĮȤİȓȡȚıȘ
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ȂȘȞİʌĮȞĮȤȡȘıȚȝȠʌȠȚİȓĲİʌȠĲȑȑȞĮİȝĳȪĲİȣȝĮĮțȩȝȘțĮȚĮȞĳĮȓȞİĲĮȚĮțȑȡĮȚȠ
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ȂȘȞİȝĳȣĲİȪİĲİĲȠǼʌȓșİȝĮȆȡȩıțȡȠȣıȘȢȉȠǼʌȓșİȝĮȆȡȩıțȡȠȣıȘȢʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚȘșİȓȝȩȞȠ
ıĲȠȕȒȝĮțȞȘȝȚĮȓĮȢʌȡȩıțȡȠȣıȘȢǹĳĮȚȡȑıĲİĲȠțĮȚʌİĲȐȟĲİĲȠĮȝȑıȦȢȝİĲȐĲȘįȚĮįȚțĮıȓĮİȝĳȪĲİȣıȘȢ
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ȂȘȞĮĳȒȞİĲİĲȚȢȖȣĮȜȚıȝȑȞİȢʌİȡȚȠȤȑȢıĲȒȡȚȟȘȢȞĮȑȡșȠȣȞıİİʌĮĳȒȝİıțȜȘȡȑȢȒįȚĮȕȡȦĲȚțȑȢ
İʌȚĳȐȞİȚİȢ
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ȅȚʌİȡȚȠȤȑȢıĲȒȡȚȟȘȢʌȡȑʌİȚȞĮİȓȞĮȚʌȐȞĲȠĲİțĮșĮȡȑȢțĮȚȤȦȡȓȢȣʌȠȜİȓȝȝĮĲĮʌȡȚȞĮʌȩĲȘ
ıȣȞĮȡȝȠȜȩȖȘıȘ

ǾȤȐȡĮȟȘĲȦȞȣȥȠȝİĲȡȚțȫȞțĮȝʌȪȜȦȞȒĲȠȜȪȖȚıȝĮİȞȩȢİȝĳȣĲİȪȝĮĲȠȢİȞįȑȤİĲĮȚȞĮȝİȚȫıİȚĲȘȞȚıȤȪ
țȩʌȦıȒȢĲȠȣțĮȚȞĮʌȡȠțĮȜȑıİȚįȣıȜİȚĲȠȣȡȖȓĮȣʌȩĳȠȡĲȓȠ

ȉȠȝİĲĮȜȜȚțȩıȪȡȝĮıȣȖțȡȐĲȘıȘȢıĲȠȑȞșİĲȠįİȞʌȡȑʌİȚȞĮĲİșİȓȣʌȩȤİȚȡȚıȝȩȒȞĮĮĳĮȚȡİșİȓ
įȚȩĲȚİȓȞĮȚțȡȓıȚȝȠȖȚĮĲȘȞĮıĳȐȜİȚĮĲȘȢıȣȞĮȡȝȠȜȩȖȘıȘȢȆİĲȐȟĲİțȐșİțȞȘȝȚĮȓȠȑȞșİĲȠıĲȒȡȚȟȘȢ
İȐȞĲȠȝİĲĮȜȜȚțȩıȪȡȝĮıȣȖțȡȐĲȘıȘȢĳĮȓȞİĲĮȚțĮĲİıĲȡĮȝȝȑȞȠȒȑȤİȚȣʌȠıĲİȓțĮțȒȝİĲĮȤİȓȡȚıȘ
!QIN4419 REV A.indd   74
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ǾʌĮȡĮʌȠȓȘıȘĮȣĲȒȢĲȘȢıȣȞĮȡȝȠȜȩȖȘıȘȢȝʌȠȡİȓȞĮȑȤİȚȦȢĮʌȠĲȑȜİıȝĮĲȘȞĮțĮĲȐȜȜȘȜȘȜİȚĲȠȣȡȖȓĮ
ĲȠȣȝȘȤĮȞȚıȝȠȪıȣȖțȡȐĲȘıȘȢ

ĬĮʌȡȑʌİȚȞĮįȠșİȓʌȡȠıȠȤȒȖȚĮȞĮȝȘȞțȠʌȠȪȞĲĮȤİȚȡȠȣȡȖȚțȐȖȐȞĲȚĮȩĲĮȞȤİȚȡȓȗİıĲİȠʌȠȚĮįȒʌȠĲİ
ȠȡșȠʌİįȚțȒıȣıțİȣȒȝİĮȚȤȝȘȡȐȐțȡĮ

ǼțĲȩȢțĮȚȩʌȠȣıȘȝİȚȫȞİĲĮȚȘǾRZPHGLFD2VWHRQLFV&RUSıȣȞȚıĲȐșİȡȝȐȞĮȝȘȞȤȡȘıȚȝȠʌȠȚȠȪȞĲĮȚ
ıĲİȜȑȤȘȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢĮʌȩȐȜȜȠȞțĮĲĮıțİȣĮıĲȒȝİȠʌȠȚĮįȒʌȠĲİĮʌȩĲĮıĲİȜȑȤȘ
ȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢĲȘȢ+RZPHGLFD2VWHRQLFVȅʌȠȚĮįȒʌȠĲİʌĮȡȩȝȠȚĮȤȡȒıȘșĮ
ĮȞĮȚȡȑıİȚĲȘȞİȣșȪȞȘĲȘȢ+RZPHGLFD2VWHRQLFV&RUSȖȚĮĲȘȞĮʌȩįȠıȘĲȠȣİȝĳȣĲİȪȝĮĲȠȢʌȠȣ
ʌȡȠȑțȣȥİĮʌȩıȣȞĮȡȝȠȜȩȖȘıȘȝİİȟĮȡĲȒȝĮĲĮįȚĮĳȠȡİĲȚțȫȞțĮĲĮıțİȣĮıĲȫȞ

Ǿ+RZPHGLFD2VWHRQLFV&RUSĮȞĲȚĲȓșİĲĮȚıĲȘȤȡȒıȘȕȓįĮȢȠıĲȫȞȐȜȜȠȣțĮĲĮıțİȣĮıĲȒȝİȠʌȠȚȠįȒʌȠĲİ
ıĲȑȜİȤȠȢȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢĲȘȢ+RZPHGLFD2VWHRQLFVİȟĮȚĲȓĮȢįȚĮĳȠȡȠʌȠȚȒıİȦȞʌȠȣ
ʌȚșĮȞȩȞȞĮȣʌȐȡȤȠȣȞıĲȘȞțİĳĮȜȒțĮȚıĲȠȞĲȡȩʌȠįȚĮȝȩȡĳȦıȘȢȖȚĮĲȘȞĲȠʌȠșȑĲȘıȘĲȘȢȕȓįĮȢ

ǾİțȠȪıȚĮĮĳĮȓȡİıȘıĲİȜȑȤȠȣȢȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢȝʌȠȡİȓȞĮİʌȚĲİȣȤșİȓȝİĲȘȞ
ʌȡȠıİțĲȚțȒȤȡȒıȘȖȜȣĳȐȞȦȞțȠʌȒȢȜİʌĲȫȞțĮȚıĲİȞȫȞȠıĲİȠĲȩȝȦȞțĮȚʌȡȠıİțĲȚțȒȢȚıȤȪȠȢİȟĮȖȦȖȒȢ

ǾİțȠȪıȚĮĮĳĮȓȡİıȘʌȜĮıĲȚțȠȪțȞȘȝȚĮȓȠȣȑȞșİĲȠȣȝİĲȐĲȘıȣȞĮȡȝȠȜȩȖȘıȒĲȠȣıĲȘȝİĲĮȜȜȚțȒȕȐıȘ
ʌȜȐțĮȢȑȤİȚȦȢĮʌȠĲȑȜİıȝĮĲȘȞțĮĲĮıĲȡȠĳȒĲȠȣʌȜĮıĲȚțȠȪȑȞșİĲȠȣĬĮʌȡȑʌİȚȞĮįȠșİȓʌȡȠıȠȤȒȞĮ
ȝȘȞțȩȥİĲİĲȘȞİʌȚĳȐȞİȚĮĲȘȢțȞȘȝȚĮȓĮȢȕȐıȘȢʌȜȐțĮȢțĮĲȐĲȘįȚȐȡțİȚĮĮĳĮȓȡİıȘȢĲȠȣȑȞșİĲȠȣ

ǼʌȚıĲȡȑȥĲİȩȜİȢĲȚȢıȣıțİȣĮıȓİȢʌȠȣĳȑȡȠȣȞİȜĮĲĲȫȝĮĲĮıĲȠĮʌȠıĲİȚȡȦȝȑȞȠĳȡȐȖȝĮĲȠȣȢıĲȠȞ
ʌȡȠȝȘșİȣĲȒȃșȟıʍįȟįʍȡĲĳıțȢȬȟıĳı
ǺȟıʍțȚȫȞșĳıȣʍįȢıȟȒȢȗıțıȣ

ǹȞțĮȚȘįȚȐȡțİȚĮȗȦȒȢĲȦȞıĲİȜİȤȫȞȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢİȓȞĮȚįȪıțȠȜȠȞĮİțĲȚȝȘșİȓ
ȖİȖȠȞȩȢİȓȞĮȚȩĲȚİȓȞĮȚʌİȡȚȠȡȚıȝȑȞȘȉĮıĲİȜȑȤȘĮȣĲȐİȓȞĮȚțĮĲĮıțİȣĮıȝȑȞĮĮʌȩȟȑȞĮʌȡȠȢ
ĲȠȞĮȞșȡȫʌȚȞȠȠȡȖĮȞȚıȝȩȣȜȚțȐĲĮȠʌȠȓĮİȝĳȣĲİȪȠȞĲĮȚıĲȠĮȞșȡȫʌȚȞȠıȫȝĮȖȚĮĲȘȞʌȚșĮȞȒ
ĮʌȠțĮĲȐıĲĮıȘțȚȞȘĲȚțȩĲȘĲĮȢĲȠȣĮĲȩȝȠȣȒĲȘȞİȜȐĲĲȦıȘĲȠȣʌȩȞȠȣȆĮȡȩȜĮĮȣĲȐİȟĮȚĲȓĮȢİȞȩȢ
ȝİȖȐȜȠȣĮȡȚșȝȠȪȕȚȠȜȠȖȚțȫȞȝȘȤĮȞȚțȫȞțĮȚĳȣıȚțȠȤȘȝȚțȫȞʌĮȡĮȖȩȞĲȦȞȠȚȠʌȠȓȠȚİʌȘȡİȐȗȠȣȞ
ĲȘıȦıĲȒȜİȚĲȠȣȡȖȓĮĮȣĲȫȞțĮȚȠȚȠʌȠȓȠȚįİȞȝʌȠȡȠȪȞȞĮİțĲȚȝȘșȠȪȞİȞȗȦȒLQYLYRįİȞʌȡȑʌİȚ
țȐʌȠȚȠȢȞĮĮȞĮȝȑȞİȚȩĲȚĲĮıĲİȜȑȤȘĮȣĲȐșĮĮȞĲȑȟȠȣȞİʌ¶ĮȩȡȚıĲȠĲȠȕĮșȝȩıȦȝĮĲȚțȒȢįȡĮıĲȘȡȚȩĲȘĲĮȢ
țĮȚĲĮįȚȐĳȠȡĮĳȠȡĲȓĮĲĮȠʌȠȓĮĮȞĲȑȤİȚȑȞĮĳȣıȚȠȜȠȖȚțȩȣȖȚȑȢȠıĲȩȅȚȤİȚȡȠȣȡȖȠȓșĮʌȡȑʌİȚȞĮ
ıȣȝȕȠȣȜİȪȠȣȞĲȠȣȢĮıșİȞİȓȢȞĮȝȘȞȑȤȠȣȞȣʌİȡȕȠȜȚțȑȢʌȡȠıįȠțȓİȢıȤİĲȚțȐȝİĲȘįȚȐȡțİȚĮȗȦȒȢĲȘȢ
ıȣıțİȣȒȢ

ȂʌȠȡİȓȞĮİʌȑȜșİȚİȟȐȡșȡȦıȘĲȘȢȝȘȡȚĮȓĮȢțȞȘȝȚĮȓĮȢȒİʌȚȖȠȞĮĲȚįȚțȒȢʌȡȩșİıȘȢİȟĮȚĲȓĮȢĮȞȐȡȝȠıĲȘȢ
ıȦȝĮĲȚțȒȢįȡĮıĲȘȡȚȩĲȘĲĮȢĲȠȣĮıșİȞȠȪȢĲȡĮȪȝĮĲȠȢȒțȐʌȠȚȠȣȕȚȠȝȘȤĮȞȚțȠȪʌĮȡȐȖȠȞĲĮ

ǼȓȞĮȚʌȚșĮȞȩȞȞĮıȣȝȕİȓȤĮȜȐȡȦıȘĲȦȞıĲİȜİȤȫȞȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢǾʌȡȫȚȝȘȝȘȤĮȞȚțȒ
ȤĮȜȐȡȦıȘȝʌȠȡİȓȞĮİȓȞĮȚĲȠĮʌȠĲȑȜİıȝĮĮȞİʌĮȡțȠȪȢĮȡȤȚțȒȢıĲȒȡȚȟȘȢȜĮȞșȐȞȠȣıĮȢȜȠȓȝȦȟȘȢ
ʌȡȩȦȡȘȢȑțșİıȘȢĲȘȢʌȡȩșİıȘȢıİĳȠȡĲȓĮȜĮȞșĮıȝȑȞȘȢİȣșȣȖȡȐȝȝȚıȘȢĲȠȣıĲİȜȑȤȠȣȢȒĲȡĮȪȝĮĲȠȢ
ǵȥȚȝȘȤĮȜȐȡȦıȘĲȘȢʌȡȩșİıȘȢȝʌȠȡİȓȞĮʌȡȠțȜȘșİȓĮʌȩĲȡĮȣȝĮĲȚıȝȩȜȠȓȝȦȟȘȕȚȠȜȠȖȚțȑȢİʌȚʌȜȠțȑȢ
ıȣȝʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢĲȘȢȠıĲİȩȜȣıȘȢȒĮʌȩȝȘȤĮȞȚțȐʌȡȠȕȜȒȝĮĲĮȝİĮʌȠĲȑȜİıȝĮİȞįİȤȩȝİȞȘ
įȚȐȕȡȦıȘĲȠȣȠıĲȠȪȒțĮȚʌȩȞȠ

ǲȤİȚĮȞĮĳİȡșİȓșȡĮȪıȘĲȦȞıĲİȜİȤȫȞȠȜȚțȒȢĮșȡȠʌȜĮıĲȚțȒȢȖȩȞĮĲȠȢĮʌȩțȩʌȦıȘʌȠȣ
ʌİȡȚȜĮȝȕȐȞȠȣȞĲĮțȞȘȝȚĮȓĮȝȘȡȚĮȓĮțĮȚİʌȚȖȠȞĮĲȚįȚțȐıĲİȜȑȤȘıİȝȚțȡȩʌȠıȠıĲȩĮıșİȞȫȞǾșȡĮȪıȘ
ıĲİȜİȤȫȞȖȠȞȐĲȠȣİȞįȑȤİĲĮȚȞĮʌȡȠțȪȥİȚİȟĮȚĲȓĮȢĮȞİʌĮȡțȠȪȢȣʌȠıĲȒȡȚȟȘȢĲȠȣıĲİȜȑȤȠȣȢĮʌȩĲȠ
ȣʌȠțİȓȝİȞȠȠıĲȩȒİȟĮȚĲȓĮȢȐıȤȘȝȘȢıĲİȡȑȦıȘȢĲȠȣıĲİȜȑȤȠȣȢ

ǼȓȞĮȚʌȚșĮȞȩȞȞĮİʌȑȜșİȚʌİȡȚĳİȡȚțȒȞİȣȡȠʌȐșİȚĮȕȜȐȕȘĲȦȞȞİȪȡȦȞțȣțȜȠĳȠȡȚțȩʌȡȩȕȜȘȝĮțĮȚ
ȑțĲȠʌȘȠıĲİȠʌȠȓȘıȘ

ǼȞįȑȤİĲĮȚȞĮıȤİĲȓȗȠȞĲĮȚıȠȕĮȡȑȢİʌȚʌȜȠțȑȢȝİțȐșİİʌȑȝȕĮıȘȠȜȚțȒȢĮȡșȡȠʌȜĮıĲȚțȒȢȅȚİʌȚʌȜȠțȑȢ
ĮȣĲȑȢʌİȡȚȜĮȝȕȐȞȠȣȞȝİĲĮȟȪȐȜȜȦȞįȚĮĲĮȡĮȤȑȢĲȠȣȠȣȡȠʌȠȚȠȖİȞȞȘĲȚțȠȪıȣıĲȒȝĮĲȠȢȖĮıĲȡİȞĲİȡȚțȑȢ
įȚĮĲĮȡĮȤȑȢĮȖȖİȚĮțȑȢįȚĮĲĮȡĮȤȑȢıȣȝʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢĲȘȢșȡȩȝȕȦıȘȢȕȡȠȖȤȠʌȞİȣȝȠȞȚțȑȢ
įȚĮĲĮȡĮȤȑȢıȣȝʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢĲȘȢİȝȕȠȜȒȢȑȝĳȡĮȖȝĮĲȠȣȝȣȠțĮȡįȓȠȣȒțĮȚșȐȞĮĲȠ

ǲȤİȚĮȞĮĳİȡșİȓĳșȠȡȐĲȦȞıĲİȜİȤȫȞʌȠȜȣĮȚșȣȜİȞȓȠȣțĮȚȠȚĮȞĮĳȠȡȑȢıĲȘȕȚȕȜȚȠȖȡĮĳȓĮıȣȞįȑȠȣȞĮȣĲȩ
ĲȠıȣȝȕȐȞȝİĲȘȞİʌĮȞĮȡȡȩĳȘıȘȠıĲȠȪĲȘȤĮȜȐȡȦıȘțĮȚĲȘȜȠȓȝȦȟȘ
!QIN4419 REV A.indd   75
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ǾİȝĳȐȞȚıȘĮȞİʌȚșȪȝȘĲȦȞİȞİȡȖİȚȫȞʌȚșĮȞȩȞȞĮĮʌĮȚĲİȓʌȡȩıșİĲȘİȖȤİȓȡȘıȘįȚȩȡșȦıȘĮȡșȡȩįİıȘ
ĲȘȢıȤİĲȚțȒȢȐȡșȡȦıȘȢȒțĮȚĮțȡȦĲȘȡȚĮıȝȩĲȠȣȝȑȜȠȣȢ
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ǲȤİȚıȣıȤİĲȚıĲİȓȘĮȞȚıȠȡȡȠʌȓĮȝĮȜĮțȠȪȚıĲȠȪȒțĮȚȤĮȜĮȡȩĲȘĲĮȝİĲȘȜĮȞșĮıȝȑȞȘİȣșȣȖȡȐȝȝȚıȘ
ıĲİȜȑȤȠȣȢʌȡȐȖȝĮĲȠȠʌȠȓȠİȞįȑȤİĲĮȚȞĮȑȤİȚȦȢĮʌȠĲȑȜİıȝĮĲȘȞʌȡȫȚȝȘĳșȠȡȐȒțĮȚĲȘȞĮʌȠĲȣȤȓĮ
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ǵʌȦȢİȓȞĮȚĳȣıȚțȩȝİȩȜİȢĲȚȢİȝĳȣĲİȣȝȑȞİȢıȣıțİȣȑȢȝʌȠȡİȓȞĮʌĮȡĮĲȘȡȘșİȓĮıȣȝʌĲȦȝĮĲȚțȐ
ʌȡȠȠįİȣĲȚțȒĮʌȠȡȡȩĳȘıȘĲȠȣȠıĲȠȪȠıĲİȩȜȣıȘĲȠʌȚțȐȖȪȡȦĮʌȩĲĮİȟĮȡĲȒȝĮĲĮĲȘȢʌȡȩșİıȘȢȦȢ
İʌĮțȩȜȠȣșȠĲȘȢĮȞĲȓįȡĮıȘȢʌȡȠȢĲȠȟȑȞȠȖȚĮĲȠȞȠȡȖĮȞȚıȝȩıȫȝĮȝİĲȠțȠțțȓȦȝĮĲıȚȝȑȞĲȠȣȝİĲȐȜȜȠȣ
ĲȠȣʌİȡȣȥȘȜȠȪȝȠȡȚĮțȠȪȕȐȡȠȣȢʌȠȜȣĮȚșȣȜȑȞȚȠXOWUDKLJKPROHFXODUZHLJKWSRO\HWK\OHQH>8+0:3(@
ȒțĮȚĲȠțİȡĮȝȚțȩȣȜȚțȩǻȘȝȚȠȣȡȖİȓĲĮȚțȠțțȓȦȝĮİȟĮȚĲȓĮȢĲȘȢĮȜȜȘȜİʌȓįȡĮıȘȢȝİĲĮȟȪĲȦȞıĲİȜİȤȫȞ
țĮșȫȢțĮȚȝİĲĮȟȪĲȦȞıĲİȜİȤȫȞțĮȚȠıĲȠȪțȣȡȓȦȢİȟĮȚĲȓĮȢȝȘȤĮȞȚıȝȫȞĳșȠȡȐȢıȪȝĳȣıȘȢİțįȠȡȐȢ
țĮȚțȩʌȦıȘȢǼʌȚʌȜȑȠȞȝʌȠȡİȓȞĮįȘȝȚȠȣȡȖȘșİȓİʌȓıȘȢțȠțțȓȦȝĮİȟĮȚĲȓĮȢĲȘȢİʌȓįȡĮıȘȢțȐʌȠȚȠȣ
ĲȡȓĲȠȣıȫȝĮĲȠȢǾȠıĲİȩȜȣıȘȝʌȠȡİȓȞĮȠįȘȖȒıİȚıİȝİȜȜȠȞĲȚțȑȢİʌȚʌȜȠțȑȢıȣȝʌİȡȚȜĮȝȕĮȞȠȝȑȞȘȢĲȘȢ
ȤĮȜȐȡȦıȘȢȖİȖȠȞȩȢʌȠȣțĮșȚıĲȐĮȞĮȖțĮȓĮĲȘȞĮĳĮȓȡİıȘțĮȚĮȞĲȚțĮĲȐıĲĮıȘĲȘȢʌȡȩșİıȘȢ
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ǼȓȞĮȚȖȞȦıĲȩȩĲȚȝİȡȚțȐʌȠȜȪȝȚțȡȐȝȩȡȚĮĮʌȩİȟĮȡĲȒȝĮĲĮȝİĲȐȜȜȠȣțĮȚʌȠȜȣĮȚșȣȜİȞȓȠȣȝʌȠȡİȓȞĮ
ʌȑıȠȣȞĮʌȩĲĮİȟĮȡĲȒȝĮĲĮțĮĲȐĲȘįȚȐȡțİȚĮıȣȞȒșȠȣȢȤȡȒıȘȢțĮȚȝİĲȘȞʌȐȡȠįȠĲȠȣȤȡȩȞȠȣǹȞțĮȚ
ĲĮʌİȡȚııȩĲİȡĮĮʌȩĮȣĲȐĲĮȣʌȠȜİȓȝȝĮĲĮʌĮȡĮȝȑȞȠȣȞİȞĲȩȢĲȠȣıȤİĲȚțȠȪıȣȞįȑıȝȠȣʌȤʌİȡȚȑȤȠȞĲĮȚ
ıĲȠȞĮȡșȡȠıȓİȜȠȒİȓȞĮȚʌĮȖȚįİȣȝȑȞĮĮʌȩʌĮȡĮțİȓȝİȞȠȚıĲȩĲĮȝȚțȡȠıțȠʌȚțȐȝȩȡȚĮįȪȞĮȞĲĮȚȞĮ
ȝİĲĮțȚȞȘșȠȪȞįȚĮȝȑıȠȣĲȠȣıȫȝĮĲȠȢȆȡȠȢĲȠʌĮȡȩȞȣʌȐȡȤȠȣȞİȡȦĲȒıİȚȢʌȠȣįİȞȝʌȠȡȠȪȝİȞĮ
ĮʌĮȞĲȒıȠȣȝİıȤİĲȚțȐȝİĲĮȣʌȠȜİȓȝȝĮĲĮțĮȚĲĮȝȚțȡȠıțȠʌȚțȐȝȩȡȚĮʌȠȣįȘȝȚȠȣȡȖȠȪȞĲĮȚĮʌȩĮȣĲȐ
ĲĮİȟĮȡĲȒȝĮĲĮǲȤİȚĮʌȠįİȚȤșİȓȩĲȚĲĮȝȚțȡȠıțȠʌȚțȐȝȩȡȚĮȣʌȠȜİȚȝȝȐĲȦȞįȪȞĮȞĲĮȚȞĮįȚĮıʌĮȡșȠȪȞ
ȝİĲĮțȚȞȘșȠȪȞįȚĮȝȑıȠȣĲȠȣıȫȝĮĲȠȢțĮȚıİȠȡȚıȝȑȞİȢʌİȡȚʌĲȫıİȚȢȑȤİȚĮȞĮĳİȡșİȓȩĲȚıȣııȦȡİȪȠȞĲĮȚ
ıĲȠȣȢȜİȝĳĮįȑȞİȢțĮȚıİȐȜȜĮȝȑȡȘĲȠȣıȫȝĮĲȠȢǹȞțĮȚȝȑȤȡȚĲȫȡĮįİȞȑȤȠȣȞĮȞĮĳİȡșİȓıȘȝĮȞĲȚțȑȢ
ȚĮĲȡȚțȑȢİʌȚʌȜȠțȑȢȦȢĮʌȠĲȑȜİıȝĮĮȣĲȫȞĲȦȞȝȠȡȓȦȞȘȝİĲĮțȓȞȘıȒĲȠȣȢȒțĮȚȘıȣııȫȡİȣıȒĲȠȣȢ
ıĲȠıȫȝĮȑȤİȚĮȞĮĳİȡșİȓıİȕȚȕȜȚȠȖȡĮĳȓĮȁȩȖȦĲȠȣĮȞİʌĮȡțȠȪȢȤȡȩȞȠȣțĮĲȐĲȘįȚȐȡțİȚĮĲȠȣȠʌȠȓȠȣ
ʌĮȡĮțȠȜȠȣșȠȪȞĲĮȚȠȚĮıșİȞİȓȢʌȠȣȑȤȠȣȞĮȣĲȑȢĲȚȢıȣıțİȣȑȢțĮȚȜȩȖȦĲȠȣȩĲȚȠȚıȣıțİȣȑȢĮȣĲȑȢ
ȤȡȘıȚȝȠʌȠȚȠȪȞĲĮȚʌȡȠȢĲȠʌĮȡȩȞıİȞİȩĲİȡȘȢȘȜȚțȓĮȢĮıșİȞİȓȢțĮȚʌĮȡĮȝȑȞȠȣȞİȞĲȩȢĲȠȣıȫȝĮĲȠȢȖȚĮ
ĮȣȟĮȞȩȝİȞİȢʌİȡȚȩįȠȣȢȤȡȩȞȠȣʌȡȑʌİȚȞĮįȘȜȦșİȓȩĲȚȠȚȝĮțȡȠȤȡȩȞȚİȢİʌȚįȡȐıİȚȢĮʌȩĮȣĲȐĲĮȝȩȡȚĮ
İȐȞȣʌȐȡȤȠȣȞİȓȞĮȚȐȖȞȦıĲİȢȊʌȐȡȤİȚȘșİȦȡȓĮȩĲȚȠȚȝĮțȡȠȤȡȩȞȚİȢİʌȚįȡȐıİȚȢʌİȡȚȜĮȝȕȐȞȠȣȞ
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ȁįȢȜȔȟȡȆȡȠȢĲȠʌĮȡȩȞįİȞȣʌȐȡȤȠȣȞİʌȚıĲȘȝȠȞȚțȑȢĮʌȠįİȓȟİȚȢʌȠȣıȤİĲȓȗȠȣȞĲĮȝİĲĮȜȜȚțȐ
ȣʌȠȜİȓȝȝĮĲĮȒĲĮȣʌȠȜİȓȝȝĮĲĮʌȠȜȣĮȚșȣȜİȞȓȠȣȝİțĮȡțȓȞȠȍıĲȩıȠįİȞįȪȞĮĲĮȚȞĮĮʌĮȜİȚĳșİȓ
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ȂıȞĴįİıȟȡʍȑȚıțįȜįțĲȤĲĲȬȢıȤĲșĲıȑȝȝȡȤȣțĲĳȡȫȣȓĲıȑȝȝįȪȢȗįȟįȊʌȐȡȤȠȣȞȝİȡȚțȑȢ
ĮȞĮĳȠȡȑȢıȣııȫȡİȣıȘȢȣʌȠȜİȚȝȝȐĲȦȞĳșȠȡȐȢıİȜİȝĳĮįȑȞİȢİȖȖȪȢțĮȚʌİȡȚĳİȡȚțȐǹȞțĮȚ
įİȞȑȤȠȣȞĮȞĮĳİȡșİȓȚĮĲȡȚțȑȢİʌȚʌȜȠțȑȢȒĮıșȑȞİȚİȢȦȢĮʌȠĲȑȜİıȝĮĮȣĲȫȞĲȦȞıȣııȦȡİȪıİȦȞ
ȘȪʌĮȡȟȒĲȠȣȢʌȡȑʌİȚȞĮĮȞĮȖȞȦȡȚıĲİȓȖȚĮĲȘȞįȚİȣțȩȜȣȞıȘįȚȐȖȞȦıȘȢțĮȚĲȘȞĮʌȠĳȣȖȒ
ıȪȖȤȣıȘȢȝİȣʌȠȥȚĮȗȩȝİȞİȢțĮțȫıİȚȢțĮȡțȚȞȠȖȩȞİȢȒȝȘ
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ȉȤĲĳșȞįĳțȜȓįĲȚȒȟıțįȊʌȐȡȤȠȣȞȠȡȚıȝȑȞİȢșİȦȡȓİȢʌȠȣȣʌȠıĲȘȡȓȗȠȣȞȩĲȚȝʌȠȡİȓȞĮȣʌȐȡȤİȚ
ıȣıȤȑĲȚıȘȝİĲĮȟȪĲȘȢȝİĲĮțȓȞȘıȘȢĲȦȞȣʌȠȜİȚȝȝȐĲȦȞțĮȚĲȦȞȑȦȢĲȫȡĮĮʌȡȠıįȚȩȡȚıĲȦȞ
ıȣıĲȘȝĮĲȚțȫȞİʌȚįȡȐıİȦȞǼȓȞĮȚʌȚșĮȞȩȞȞĮĮʌȠįİȚȤșİȓțȐʌȠȚĮȝĮțȡȠȤȡȩȞȚĮİʌȓįȡĮıȘıĲȠ
ȝȑȜȜȠȞĮȜȜȐȜȩȖȦĲȠȣȩĲȚȣʌȐȡȤȠȣȞʌȠȜȪİȜȐȤȚıĲĮİʌȚıĲȘȝȠȞȚțȐįİįȠȝȑȞĮʌȠȣȣʌȠįİȚțȞȪȠȣȞ
ıȣıȤȑĲȚıȘȝİĲĮȟȪĲȘȢȝİĲĮțȓȞȘıȘȢĲȦȞȣʌȠȜİȚȝȝȐĲȦȞțĮȚțȐʌȠȚĮȢıȣıĲȘȝĮĲȚțȒȢĮıșȑȞİȚĮȢ
șİȦȡİȓĲĮȚȩĲȚĲĮȠĳȑȜȘĮʌȩĮȣĲȑȢĲȚȢıȣıțİȣȑȢȣʌİȡȕĮȓȞȠȣȞʌȡȠĳĮȞȫȢĲȠȣȢʌȚșĮȞȠȪȢțȚȞįȪȞȠȣȢ
ȖȚĮȠʌȠȚĮįȒʌȠĲİșİȦȡȘĲȚțȒȝĮțȡȠȤȡȩȞȚĮİʌȓįȡĮıȘ
ǺȝȝșȝıʍȔİȢįĲșȞıǺʍıțȜȪȟțĲșȃįȗȟșĳțȜȓȣȊȡȞȡȗȢįĴȔįȣ
ȉȠȈȪıĲȘȝĮǹȡșȡȠʌȜĮıĲȚțȒȢīȠȞȐĲȠȣ7ULDWKORQįİȞȑȤİȚĮȟȚȠȜȠȖȘșİȓȖȚĮĮıĳȐȜİȚĮțĮȚıȣȝȕĮĲȩĲȘĲĮıİ
ʌİȡȚȕȐȜȜȠȞȝĮȖȞȘĲȚțȒȢĲȠȝȠȖȡĮĳȓĮȢȉȠȈȪıĲȘȝĮǹȡșȡȠʌȜĮıĲȚțȒȢīȠȞȐĲȠȣ7ULDWKORQįİȞȑȤİȚĲİșİȓȣʌȩ
įȠțȚȝĮıȓĮȖȚĮșȑȡȝĮȞıȘȒȝİĲĮĲȩʌȚıȘıİʌİȡȚȕȐȜȜȠȞȝĮȖȞȘĲȚțȒȢĲȠȝȠȖȡĮĳȓĮȢ
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4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ĮİȡȓȠȣȣʌİȡȠȟİȚįȓȠȣĲȠȣȣįȡȠȖȩȞȠȣǹȞĮĳİȡșİȓĲİıĲȘȞİĲȚțȑĲĮĲȘȢıȣıțİȣĮıȓĮȢıȤİĲȚțȐȝİĲȘȝȑșȠįȠ
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ĬĮʌȡȑʌİȚȞĮİʌȚșİȦȡİȓĲİĲȘıȣıțİȣĮıȓĮȩȜȦȞĲȦȞĮʌȠıĲİȚȡȦȝȑȞȦȞʌȡȠȧȩȞĲȦȞȖȚĮĲȣȤȩȞİȜĮĲĲȫȝĮĲĮ
ıĲȠĮʌȠıĲİȚȡȦȝȑȞȠĳȡȐȖȝĮĲȠȣȢʌȡȠĲȠȪĲĮĮȞȠȓȟİĲİǼȐȞȣʌȐȡȤİȚțȐʌȠȚȠİȜȐĲĲȦȝĮĲȠʌȡȠȧȩȞʌȡȑʌİȚ
ȞĮșİȦȡȘșİȓȝȘĮʌȠıĲİȚȡȦȝȑȞȠǻȚĮĲȓșİȞĲĮȚİȚįȚțȑȢʌȡȠșȑıİȚȢįȠțȚȝȒȢȖȚĮȞĮȝȘȞȤȡİȚȐȗİĲĮȚȞĮĮȞȠȓȟİĲİ
ȠʌȠȚȠįȒʌȠĲİȝȑȡȠȢĲȘȢĮʌȠıĲİȚȡȦȝȑȞȘȢıȣıțİȣĮıȓĮȢʌȡȚȞĮʌȩĲȘȤȡȒıȘĲȠȣİȟĮȡĲȒȝĮĲȠȢ

ĬĮʌȡȑʌİȚȞĮįȦșİȓʌȡȠıȠȤȒʌȡȠȢĮʌȠĳȣȖȒȝȩȜȣȞıȘȢĲȠȣİȟĮȡĲȒȝĮĲȠȢȈİʌİȡȓʌĲȦıȘʌȠȣȝȠȜȣȞșİȓ
ĲȠʌȡȠȧȩȞșĮʌȡȑʌİȚȞĮĲȠĮʌȠȡȡȓȥİĲİ

ǼȐȞȘıȣıțİȣĮıȓĮȑȤİȚĮȞȠȚȤĲİȓĮȜȜȐĲȠʌȡȠȧȩȞįİȞȑȤİȚȤȡȘıȚȝȠʌȠȚȘșİȓĲȠİȟȐȡĲȘȝĮįİȞʌȡȑʌİȚȞĮ
İʌĮȞĮʌȠıĲİȚȡȦșİȓțĮȚʌȡȑʌİȚȞĮĮʌȠȡȡȚĳșİȓȒȞĮİʌȚıĲȡĮĳİȓıĲȠȞʌȡȠȝȘșİȣĲȒ

ǾıȣıțİȣȒįİȞʌȡȑʌİȚȞĮȤȡȘıȚȝȠʌȠȚȘșİȓĮĳȩĲȠȣʌĮȡȑȜșİȚȘȘȝİȡȠȝȘȞȓĮȜȒȟȘȢʌȠȣĮȞĮȖȡȐĳİĲĮȚ
ıĲȘȞİĲȚțȑĲĮĲȘȢıȣıțİȣĮıȓĮȢįȚȩĲȚĲȠʌȡȠȧȩȞįİȞȑȤİȚĮȟȚȠȜȠȖȘșİȓȖȚĮȤȡȒıȘȝİĲȐĮʌȩĮȣĲȒȞĲȘȞ
ȘȝİȡȠȝȘȞȓĮ

ȈȣıțİȣȑȢȝȓĮȢȤȡȒıȘȢįİȞȝʌȠȡȠȪȞȞĮİțĳȣĲİȣĲȠȪȞțĮȚȞĮİȝĳȣĲİȣĲȠȪȞİțȞȑȠȣțĮĲȩʌȚȞțĮșȫȢ
ȠȚĳȣıȚțȑȢįȣȞȐȝİȚȢʌȠȣĮıțȠȪȞĲĮȚĮʌȩĮȣĲȑȢĲȚȢİȞȑȡȖİȚİȢİȞįȑȤİĲĮȚȞĮįȚĮțȣȕİȪıȠȣȞĲȘĳȣıȚțȒ
ĮțİȡĮȚȩĲȘĲĮĲȚȢįȚĮıĲȐıİȚȢȒțĮȚĲȠĳȚȞȓȡȚıȝĮĲȘȢİʌȚĳȐȞİȚĮȢĲȦȞıȣıțİȣȫȞǼʌȓıȘȢįİȞįȪȞĮĲĮȚ
ȞĮįȚĮıĳĮȜȚıĲİȓȘıĲİȚȡȩĲȘĲĮĲȦȞıȣıțİȣȫȞʌȠȣȑȤȠȣȞȤȡȘıȚȝȠʌȠȚȘșİȓİțȞȑȠȣțĮșȫȢįİȞȑȤȠȣȞ
İʌĮȜȘșİȣĲİȓȠȚįȚĮįȚțĮıȓİȢțĮșĮȡȚıȝȠȪțĮȚİʌĮȞĮʌȠıĲİȓȡȦıȘȢ
ȇȈȆȉȆȌǿ
ȊȆȆȃȆȉȇȆȄǼȀǺȁȆǼȀȁǺȀȆǿȇ$ȇǽȈȀȆȈȀǾǽȀȊǿȄȇȎȂǿȉǿȊǿȉȉȋȉȁǽȋǿȉ
ȉǽȀǺȊȈȆǴȁǺȊȆȇȀȄǽȄȊȆȂǿȉȀǺȊȈȆȋ
ȇȈȆǽȀǼȆȇȆȀǿȉǿ
ȉĮİȟĮȡĲȒȝĮĲĮʌȠȣĳȑȡȠȣȞĲȘȞİʌȚıȒȝĮȞıȘ©ȂȩȞȠȖȚĮȤȡȒıȘȝİĲıȚȝȑȞĲȠªʌȡȑʌİȚȞĮ
İȝĳȣĲİȪȠȞĲĮȚȝȩȞȠȝİȠıĲȚțȩĲıȚȝȑȞĲȠ
Ǿ6WU\NHU&RUSRUDWLRQȒĲĮȣʌȠțĮĲĮıĲȒȝĮĲȐĲȘȢȒȐȜȜİȢșȣȖĮĲȡȚțȑȢİĲĮȚȡİȓİȢȑȤȠȣȞıĲȘȞțĮĲȠȤȒĲȠȣȢ
ȤȡȘıȚȝȠʌȠȚȠȪȞȒȑȤȠȣȞȣʌȠȕȐȜİȚĮȚĲȒıİȚȢȖȚĮĲĮĮțȩȜȠȣșĮİȝʌȠȡȚțȐıȒȝĮĲĮ+RZPHGLFD2VWHRQLFV
6WU\NHU7ULDWKORQǵȜĮĲĮȐȜȜĮİȝʌȠȡȚțȐıȒȝĮĲĮĮʌȠĲİȜȠȪȞȚįȚȠțĲȘıȓĮĲȦȞĮȞĲȓıĲȠȚȤȦȞțĮĲȩȤȦȞȒ
įȚțĮȚȠȪȤȦȞĲȠȣȢ
ǹȞĮĲȡȑȟĲİıĲȘȞİĲȚțȑĲĮĲȠȣʌȡȠȧȩȞĲȠȢȖȚĮĲȘȞȣʌȩıĲĮıȘĲȘȢıȒȝĮȞıȘȢ&(țĮȚĲȠȞȞȩȝȚȝȠțĮĲĮıțİȣĮıĲȒ
ǾıȒȝĮȞıȘ&(İȓȞĮȚȑȖțȣȡȘȝȩȞȠĮȞĮȞĮȖȡȐĳİĲĮȚİʌȓıȘȢıĲȘȞİĲȚțȑĲĮĲȠȣʌȡȠȧȩȞĲȠȢ
!QIN4419 REV A.indd   77
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


ȅĮțȩȜȠȣșȠȢʌȓȞĮțĮȢʌİȡȚȜĮȝȕȐȞİȚȑȞĮȞțĮĲȐȜȠȖȠĲȦȞıȣȞĲȝȒıİȦȞʌȠȣȤȡȘıȚȝȠʌȠȚȠȪȞĲĮȚıĲȘȞ
İĲȚțİĲȠʌȠȓȘıȘĲȦȞʌȡȠȧȩȞĲȦȞĲȘȢ+RZPHGLFD2VWHRQLFV&RUS
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!QIN4419 REV A.indd   78
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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⌞φ7ULDWKORQ7ULWDQLXPᓋᶵф䭚ޛಞ෡ऻ㻻൞ж䎭Ⱦ䭚ޛಞ෡ሼ⭞ӄ㜡僞ᓋᶵᎂޛ↛僚
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儂僞㓺Ԭޞງሯ〦фуሯ〦ԛ਀䠇ኔ㺢㜂䇴䇗ൽᨆב儂僞߃⎸ቸ㓺ԬȾ儂僞㓺ԬⲺֵ⭞ᱥ
ਥ䘿ⲺȾ7ULDWKORQ7ULWDQLXPᓋᶵфᡶᴿⲺ7ULDWKORQ儂僞㓺Ԭ޲ᇯȾ
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㢸⛄Ƚࡑ՚ᙝީ㢸ᡌᰖ㹶㇗ᙝඅ↱εȽ伄⒵ᙝީ㢸⛄ᡌࡑ՚੄ީ㢸⛄Ⱦ
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7ULDWKORQ7ULWDQLXPᓋᶵੂᰬ䘸⭞ӄᰖ僞≪⌛ૂ僞≪⌛രᇐⲺ⭞䙊Ⱦ
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!QIN4419 REV A.indd   79
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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ཌ〇ॱ⭕ᓊ䆜઀ᛙ㘻▒൞Ⲻу㢥֒⭞θऻᤢ㻻㖤Ⲻᴿ䲆ֵ⭞ስળԛ਀ᢁᵥ੄ሯὃޛ։Ⲻ
ؓᣚȾཌ〇ॱ⭕ᓊᖉ䆜઀ᛙ㘻θὃޛ㻻㖤⋗ᴿ↙ᑮڛᓭީ㢸Ⲻ⚫⍱ᙝȽᕰᓜȽਥ䶖ᙝᡌ
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ޞ㟓㓺ԬⲺ↙⺤䘿᤟Ƚᆿ㖤ૂരᇐθᱥᖧଃٽ։ֵ⭞ስળⲺީ䭤ഖ㍖Ⱦ䘏ӑ㓺Ԭੂᡶ
ᴿٽ։ὃޛ⢟жṭθ਍ࡦ਺〃⭕⢟ᆜȽ⭕⢟࣑ᆜૂެԌཌ൞ഖ㍖Ⲻᖧଃθ䲆࡬ެֵ⭞⭕
ળȾഖ↚θᗻ亱ћṲ䚫ᆾީӄᵢӝ૷䘸ᓊ⯽Ƚ⾷ᘂ⯽Ƚ人䱨᧠᯳ૂ䆜⽰Ӂ亯Ⲻ㿺ᇐθᢃ
㜳ݻ࠼ᔬ䮵ӝ૷Ⲻֵ⭞ስળȾ
ֵ⭞ૂὃޛ

ֵ⭞ᡶ᧞㦆Ⲻ䈋僂㓺Ԭᶛߩᇐٽ։ཝቅȽ䈋僂གྷփૂ䇺զ⍱ࣞᓜθԄ㙂ؓᤷᇔ䱻ὃޛ։
Ⲻᇂ᮪ᙝૂᰖ㨂ऻ㻻⣬ᘷȾ

༽ᴿ᭴ሺ᩺ᖧ⁗ᶵθਥ⭞ӄঅࣟ൞ᢁᵥࢃ人⎁㓺ԬተሮૂᖘᘷȾ

␻䲚ὃޛ։䜞փⲺ僞ኇȽ僞≪⌛⻄⡽ૂ䠇ኔ⻄⡽ᰬᓊቅᗹθԛ䲃քഖὃޛ։ީ㢸㺞䶘ࣖ
䙕⼞ᦕ㙂䈧ਇ⻄⡽Ⲻ伄䲟Ⱦ

Ʌ+RZPHGLFD2VWHRQLFV&RUSਮཌ〇ᢁᵥ㿺ぁɆѣᨆבҼᢁᵥᬃ֒㺛ݻؗᚥȾ

ᴿީޭ։ӝ૷Ⲻ޲ᇯᙝθ䈭ḛ䰻ӝ૷ḽㆴȾ䙐ᑮ䘸⭞сࡍ᛻߫φ
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ӻф36㜡僞ᢵᢎж䎭ֵ⭞36㛗僞
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ӻф&5㜡僞ᢵᢎж䎭ֵ⭞&5㛗僞
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ф&6㜡僞ᢵᢎж䎭ֵ⭞36ᡌ&5㛗僞
ᛙ㘻亱⸛

ཌ〇ॱ⭕ᗻ亱઀⸛ᛙ㘻ީ㢸䠃ᔰⲺቶ䲆ᙝθ䘎㾷䚵ރὃޛ⢟ᢵ਍䓡։ޞ䠃θ⴪ࡦݻ࠼
രᇐૂ᜾ਾȾ䗽䠅⍱ࣞૂཌ՚ਥ㜳ഖٽ։ὃޛ⢟ⲺᶴࣞȽ⹪㻸ૂᡌ⼞ᦕሲ㠪䠃ᔰཧ䍛θ
!QIN4419 REV A.indd   80
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


Ԅ㙂ᖧଃީ㢸㖤ᦘ⢟Ⲻࣕ㜳Ⱦὃޛ⢟㓺ԬⲺᶴࣞਥ㜳໔ࣖ⼞ᦕ仍㋈Ⲻӝ⭕θሯ僞僲䙖ᡆ
՚ᇩθֵ㘱ؤᢁᵥ䖹䳴ᡆࣕȾ

ཌ〇ॱ⭕ᓊᖉ䆜઀ᛙ㘻㾷䲆࡬⍱ࣞθ䚵ރ㖤ᦘީ㢸ᢵ਍䗽ᓜু࣑θᒬъ㾷䚫ᗠॱ⭕Ⲻ
᤽⽰䘑㺂䳅䇵ᣚ⨼ૂ⋱⯍Ⱦ

ཌ〇ॱ⭕ᓊᖉ䆜઀ᛙ㘻ᢁᵥⲺধ䲟਀ਥ㜳ਇ⭕Ⲻу㢥ਃᓊȾཌ〇ॱ⭕ᓊᖉ䆜઀ᛙ㘻ὃޛ
㻻㖤уᱥ↙ᑮڛᓭީ㢸Ⲻགྷ࡬૷θᆹਥ㜳Ր⭧ӄ࢝⛾⍱ࣞᡌཌ՚㙂⹪㻸ᡌᦕඅθᒬъެ
ֵ⭞ስળᴿ䲆θᵠᶛਥ㜳䴶㾷ᴪᦘȾ

ᛙ㘻൞ᰛᑮ⭕⍱ѣਥ㜳Րᛙ⸣Ჸ㨂㹶⯽Ⱦ⢏喵ᬃ֒Ƚ޻ホ䮒ỶḛૂެԌቅཌ〇ᢁᵥҕф
⸣Ჸ㨂㹶⯽ᴿީȾѰ䱨↘ὃޛ⢟䜞փਇ⭕᝕ḉθਥ൞ὃޛᵥࢃ੄䟽⭞ᣍ⭕㍖人䱨Ⱦ
䆜⽰Ӂ亯

јᔹᡶᴿᐨᦕඅᡌᬃ֒уᖉⲺὃޛ։Ⱦ

࠽व䠃᯦ֵ⭞ὃޛ։θ঩ֵὃޛ։ⵁղᇂླȾ

䈭वὃޛ䭚ޛಞ෡Ⱦ䭚ޛಞ෡ӻ⭞ӄ㜡僞ᓋᶵᎂޛ↛僚ᵕ䰪Ⱦᎂޛぁᓅ੄㄁঩〱䲚ᒬ
јᔹȾ

࠽वֵᣑݿⲺᢵᢎ㺞䶘᧛䀜ඐ⺢ᡌ᪟ᬜᙝ㺞䶘Ⱦ

ᢵᢎ॰ต൞㓺㻻ࢃᗻ亱ခ㓾ؓᤷᒨ߶θ㙂ъᰖԱ֋⻄ኇȾ

ٽ։ཌᖘ᭯਎ᡌᕥᴨਥ㜳䲃քٽ։⯨ࣩᕰᓜθᒬֵҁ൞䍕㦭сཧ⚫Ⱦ

уᓊ䀜ࣞᡌ਌с޻㺢рⲺ䠇ኔരփѓθ䘏жരփѓሯ᮪Ѡ㻻䞃ԬⲺ⢘രᙝᶷѰ䠃㾷Ⱦྸ
᷒䠇ኔരփѓⵁղᦕඅᡌ㻡уᖉ䀜ࣞ䗽θሼ㜡僞ᢵᢎ޻㺢јᔹȾ䳅ᝅ᭯ࣞᵢ㻻䞃Ԭਥ㜳
ሲ㠪രᇐᵰ࡬ࣕ㜳ཧᑮȾ

ᬃ֒Ա֋䗯㕎ቌ࡟Ⲻ⸡ᖘཌ〇ಞỦᰬൽᓊቅᗹθ࠽वࢨ⹪ཌ〇ᢁᵥᢁྍȾ

䲚䶔ਜᴿ䈪᱄θੜࡏ+RZPHGLFD2VWHRQLFV&RUSਮᕰ⛾ᔰ䇤у㾷ሼެԌ࡬䙖୼⭕ӝ
Ⲻޞ㟓㓺ԬфԱ֋+RZPHGLFD2VWHRQLFVޞ㟓㓺Ԭж䎭ֵ⭞Ⱦ+RZPHGLFD2VWHRQLFV
&RUSਮሯԱ֋р䘦␭ਾ㓺Ԭὃޛ։Ⲻࣕ᭾Ᾰуᢵ᣻䍙ԱȾ

⭧ӄ㷰䪿ૂ㷰ᆊⲺ䞃㖤ᴿᐤᔸθ+RZPHGLFD2VWHRQLFV&RUSਮᕰ⛾ᔰ䇤у㾷ሼެԌ࡬
䙖୼⭕ӝⲺ僞㷰䪿фԱ֋+RZPHGLFD2VWHRQLFVޞ㟓㓺Ԭж䎭ֵ⭞Ⱦ

ྸ㫺ᝅ਌࠰ޞ㟓㓺Ԭθਥֵ⭞僞䫱ૂ㮺㙂ズⲺ僞࠵θᒬቅᗹ਌࠰࣑䚉Ⱦ

ྸ൞ງᯏ㜡僞޻㺢ᐨ㻻ޛ䠇ኔᓋᶵ੄߃㫺ᝅ਌࠰θՐ⇷අງᯏ޻㺢Ⱦ਌࠰޻㺢ᰬᓊቅᗹ
ᬃ֒θԛރ൞㜡僞ᓋᶵ㺞䶘⮏сࡈⰋᡌࡱⰋȾ

⭞ᰖ㨂ऻ㻻ᶆᯏऻླᡶᴿᑜ㕰䲭Ⲻӝ૷θᒬ䘶ഔ㔏בᓊ୼Ⱦуਥ䠃᯦֒⚣㨂༺⨼Ⱦ
у㢥ਃᓊ

ޞ㟓㖤ᦘ㓺ԬⲺ人ᵕֵ⭞ስળᖾ䳴զ䇗θռ㛥ᇐᱥᴿ䲆ᓜⲺȾ䘏ӑ㓺Ԭᱥ⭞ཌⓆᶆᯏ࡬
䙖Ⲻθሼެ㖤ޛᛙ㘻։޻θԛᵕᚘགྷᛙ㘻Ⲻ⍱ࣞ㜳࣑ᡌࠅቇ⯲ⰑȾռᱥθ⭧ӄ䘏ӑ㓺Ԭ
਍ࡦ䈮ཐ⭕⢟ᆜȽ࣑ᆜૂ⢟⨼ौᆜഖ㍖Ⲻᖧଃθ㙂ሯ䘏ӑᖧଃ৾ᰖ⌋֒։޻䇺ᇐθഖ↚
у㜳ᵕᵑ䘏ӑ㓺Ԭ㜳ᰖ䲆൦ᢵ਍↙ᑮڛᓭ僞僲ᡶ㜳ᢵ਍Ⲻ⍱ࣞぁᓜૂ䍕㦭Ⱦཌ〇ॱ⭕ᓊ
઀⸛ᛙ㘻वሯ㻻㖤ስળᴿу࠽ᇔ䱻ⲺᵕᖻȾ

ᛙ㘻⍱ࣞуᖉȽཌ՚ᡌެԌ⭕⢟࣑ᆜ৕ഖ䜳Րᕋ䎭㛗僞Ƚ㜡僞ᡌ儂僞ٽ։㝧փȾ

ਥ㜳Րਇ⭕ޞ㟓㓺ԬᶴࣞⲺ᛻߫Ⱦ㓺ԬⲺᰟᵕᵰỦᙝᶴࣞਥ㜳ᱥ⭧ӄࡓခരᇐуᖉȽ
!QIN4419 REV A.indd   81
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


▒Յᙝ᝕ḉȽٽ։䍕㦭䗽ᰟȽ㓺Ԭᧈࡍу喆ᡌཌ՚㙂ᕋ䎭Ⱦਥ㜳Րᕋ䎭ٽ։ᲐᵕᶴࣞⲺ
৕ഖऻᤢཌ՚Ƚ᝕ḉԛ਀ऻᤢ僞䍞⓬䀙൞޻Ⲻ⭕⢟ᆜᒬਇ⯽ᡌ࣑ᆜ䰤从θᒬᴿਥ㜳ሲ㠪
੄㔣Ⲻ僞㌒⛸ૂᡌ⯲ⰑȾ

ᴴਇ⭕䗽ޞ㟓㓺Ԭθऻᤢ㜡僞Ƚ㛗僞ૂ儂僞㓺ԬⲺ⯨ࣩᙝ⹪㻸᛻߫θռਇ⭕ᵰ⦽ᖾቅȾ
⭧ӄᓋቸ僞ሯ㓺ԬⲺ᭥᫇уཕᡌ㘻㓺Ԭരᇐу֩θᴿਥ㜳ሲ㠩㟓ⴌ㓺Ԭ⹪㻸Ⱦ
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ਥ㜳Րਇ⭕ཌઞ⾔㔅⯴⯻Ƚ⾔㔅ᦕ՚Ƚᗠ⧥਍ᦕૂᔸփᙝ僞ौᖘᡆȾ
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Ա֋ޞީ㢸㖤ᦘᢁᵥ䜳ᴿਥ㜳ᕋ䎭ћ䠃Ⲻᒬਇ⯽Ⱦ䘏ӑᒬਇ⯽ऻᤢռу䲆ӄφ⭕⇌⌂ት
⯴⯻χ㛹㛖⯴⯻χ㹶ṉㅿ㹶㇗⯴⯻χṉດㅿ᭥≊㇗㛰⯴⯻χᗹ㛂ọ↱ᡌ↱ӗȾ
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ᴴਇ⭕䗽㚐ҏ✥㓺Ԭ⼞ᦕⲺ᛻߫θᒬᴿᮽ⥤᤽࠰ެ⼞ᦕф僞੮᭬Ƚᶴࣞૂ᝕ḉᴿީȾ
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ᴴᴿީ㢸㖤ᦘᢁᵥ੄ਇ⭕䠇ኔ䗽ᮅਃᓊⲺᣛ䚉Ⱦ
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ྸ᷒ਇ⭕у㢥֒⭞θਥ㜳䴶㾷ሯ⴮ᓊީ㢸䠃᯦ڐᢁᵥᡌ䘑㺂㘱ؤᵥȽީ㢸രᇐᵥૂ
ᡌᡠ㛘Ⱦ
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䖥㓺㓽ཧ㺗ૂᡌᶴᕑж⴪ф㓺Ԭᧈࡍу喆ᴿީθਥ㜳ሲ㠪ὃޛ։Ⲻᰟᵕ⼞ᦕૂᡌཧ䍛Ⱦ
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ֵ⭞Ա֋ὃޛ㻻㖤䜳ᴿਥ㜳ሯ僞≪⌛Ƚ䠇ኔȽ䎻儎࠼ᆆ䠅㚐ҏ✥δ8+0:3(εૂᡌ䲬⬭Ⲻ
ᗤ㋈⢟䍞ਇ⭕ᔸ։ਃᓊθᒬഖ↚൞ٽ։㓺Ԭ䗯㕎࠰⧦ᰖ⯽⣬Ƚቶ䜞⑆䘑ᙝ僞੮᭬δ僞䍞
⓬䀙εȾ䘏ӑᗤ㋈ᱥ൞㓺Ԭҁ䰪ԛ਀㓺Ԭф僞僲ҁ䰪Ⲻ⴮ӈ֒⭞䗽ぁѣӝ⭕Ⲻθѱ㾷ᱥ
䙐䗽㋎䱺Ƚ⼞ᦕૂ⯨ࣩⲺ㙍ᦕᵰ࡬䙖ᡆȾެ⅗θҕਥ㜳⭧ӄㅢпԁ䍞⼞ᦕ㙂ӝ⭕Ⱦ僞䍞
⓬䀙Րሲ㠪ᵠᶛⲺᒬਇ⯽θऻᤢᶴࣞθ㙂ᗻ亱਌࠰ᒬ㖤ᦘٽ։㓺ԬȾ
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ж㡢䇚Ѱθ൞↙ᑮֵ⭞ᵕ䰪ᡌ䮵ᵕֵ⭞੄θ㓺ԬⲺ䠇ኔૂ㚐ҏ✥⻄ኇਥ㜳㝧㩳жӑᶷቅ
Ⲻ仍㋈Ⱦ㲳❬ཝ䜞࠼⻄ኇՐ⮏൞⴮ީⲺީ㢸ѣδ঩ऻ੡൞┇㟒ѣεᡌ㻡ઞപ՚Ⰻ㓺㓽ᦋ
㧭θռᱥᗤቅ仍㋈ҕਥ㜳Ԅީ㢸ཌੇ䓡։ެԌ䜞փ〱ࣞᡌ⑮〱Ⱦᖉࢃθሯӄਥ㜳Ԅ䘏ӑ
㓺Ԭӝ⭕Ⲻ⻄ኇૂᗤቅ仍㋈䘎ᴿᛢ㙂ᵠߩⲺ⯇䰤Ⱦᐨ㔅䇷᱄θᗤቅ仍㋈ҕਥ㜳ੇ᮪Ѡ䓡
։ᢟᮙδ䖢〱εθڬቊᴿ仍㋈〥㍥ӄ␁ᐪ㔉ᡌ䓡։ެԌ䜞փⲺᣛ䚉Ⱦ㲳❬䗺ԀѰ↘⋗ᴿ
ഖ䘏ӑ仍㋈㙂䙖ᡆћ䠃ॱ⯍ᒬਇ⯽Ⲻᣛ䚉θռᱥᮽ⥤ѣᴿީӄ䘏ӑ仍㋈൞䓡։޻⑮〱ૂ
ᡌ〥㍥Ⲻ䇦䖳Ⱦ⭧ӄሯ䘏ӑ㻻㖤ὃޛᛙ㘻Ⲻ䳅䇵ᰬ䰪уཕݻ࠼θࣖр䘏ӑ㻻㖤ⴤࢃ↙㻡
⭞ӄ䖹ᒪ䖱Ⲻᛙ㘻θᒬഖ↚൞։޻ᆎ⮏ᴪ䮵Ⲻᰬ䰪θᓊ䈛䈪θྸ᷒䘏ӑ仍㋈Ր䙖ᡆӶѾ
䮵ᵕᖧଃⲺ䈓θ䘏ӑ੄᷒ᱥӶѾ⧦൞ቐу␻ᾐȾԄ⨼䇰р࠼᷆θ䘏ӑ䮵ᵕᖧଃሼऻᤢφ
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Ⲃ⯽φⴤࢃቐᰖԱ֋〇ᆜ䇷ᦤᱴ⽰䠇ኔᡌ㚐ҏ✥⻄ኇфⲂ⯽ᴿީȾռу㜳ᧈ䲚䘏
〃ਥ㜳ᙝȾ
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ㄥૂ䘒ㄥ␁ᐪ㔉εⲺᣛ䚉Ⱦ㲳❬ቐᰖഖ䘏ӑ仍㋈〥㍥㙂ሲ㠪ᒬਇ⯽Ⲻᣛ䚉θռᓊ䈛
Ҽ䀙䘏ӑ仍㋈Ⲻᆎ൞θԛ䖻ࣟ⯻᛻䈀ᯣθ䚵ރфⲂ⯽ᡌެԌਥ⯇⯻਎ਇ⭕␭⏼Ⱦ
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ޞ䓡ᙝ⯴⯻φᴿӑ᧞⎁䇚Ѱθ㝧㩳仍㋈Ⲻ⑮〱ᴿਥ㜳фቐᵠ᱄⺤Ⲻޞ䓡ᙝᖧଃᴿ
ީȾҕ䇮ሼᶛḆѠᰬُḆӑ䮵ᵕᖧଃਥ㜳ਥԛᗍࡦ䇷ᇔθռᱥ⭧ӄⴤࢃ㜳ཕ᧞⎁䘏
ӑ仍㋈⑮〱фޞ䓡ᙝ⯴⯻ᴿީⲺ〇ᆜᮦᦤᶷቇθᡶԛⴤࢃਥԛ⴮ؗθֵ⭞䘏ӑ㻻㖤
Ⲻ㧭ⴀ᱄ᱴཝӄԱ֋⨼䇰рⲺ䮵ᵕᖧଃⲺ▒൞ধ䲟ᙝȾ
ф⻷ާᥥᡆ܅ⲺӚӈ֒⭞
7ULDWKORQ㟓ީ㢸㌱㔕ቐᵠ㔅䗽⻷ާᥥ⧥ູсⲺᆿޞᙝૂ޲ᇯᙝ䇺զȾ7ULDWKORQ㟓ީ㢸㌱
㔕ቐᵠ㔅䗽⻷ާᥥ⧥ູсࣖ✣ᡌ⑮〱Ⲻ⎁䈋Ⱦ
!QIN4419 REV A.indd   82
4/8/2013   1:07:27 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


⚣㨂
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൞ᢉᔶᡶᴿᰖ㨂ӝ૷ऻ㻻ҁࢃθൽᓊݾỶḛᰖ㨂ऻ㻻ᱥੜᴿ㕰䲭Ⱦྸ᷒ਇ⧦ᴿ㕰䲭θᗻ
亱ሼ䘏ӑӝ૷㿼Ѱ䶔ᰖ㨂ӝ૷Ⱦ༽ᴿ䈋僂⭞ٽ։⁗ශθԛރ൞ֵ⭞㓺Ԭҁࢃᢉᔶᰖ㨂ӝ
૷ⲺԱ֋ऻ㻻䜞ԳȾ
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ᓊቅᗹ䉞ងθ䱨↘ٽ։㓺Ԭ਍⊗ḉȾྸ᷒ӝ૷਍ࡦ⊗ḉθᗻ亱ሼެјᔹȾ
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ྸ᷒ӝ૷㻡ᢉᔶռᵠֵ⭞θ㔓ሯу㾷ሼٽ։㓺Ԭ䠃᯦⎾∈θ㙂ᓊሼެјᔹᡌ䘶ഔ㔏בᓊ୼Ⱦ
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㻻㖤уᓊ൞ḽㆴрᱴ⽰Ⲻࡦᵕᰛҁ੄ֵ⭞θഖѰऻ㻻ቐᵠ㔅䗽䎻䗽䈛ᰛᵕԛ੄Ⲻ僂䇷Ⱦ
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ж⅗ᙝֵ⭞Ⲻ㻻㖤у㜳਌࠰ҁ੄߃ᓜὃޛθഖѰ䘏ӑ㺂ࣞᡶ᯳ࣖⲺ⢟⨼࣑䠅ਥ㜳Ր⹪අ
㻻㖤Ⲻ⢟⨼ᇂ᮪ᙝȽཝቅૂᡌ㺞䶘༺⨼Ⱦ⭧ӄ␻⌷ૂ䠃᯦⚣㨂ぁᓅቐᵠ㔅䗽僂䇷θഖ↚
ҕᰖ⌋⺤ؓ䠃᯦ֵ⭞Ⲻ㻻㖤Ⲻᰖ㨂ᙝȾ
⌞ᝅφ
㚊䛜⌋ᗁδ㗄ളε㿺ᇐθ↚㻻㖤ӻ䲆⭧ॱ⭕䬶୤ᡌࠣॱ౧䬶୤Ⱦ
䆜઀φ
ḽѰćӻ䲆僞≪⌛രᇐ⭞䙊ĈⲺ㓺Ԭਠ㜳ֵ⭞僞≪⌛ὃޛȾ
6WU\NHU&RUSRUDWLRQਮᡌެ࠼ޢਮᡌެԌ䱺ኔޢਮᇔ։ᤛᴿȽֵ⭞ᡌᐨ㔅⭩䈭сࡍ୼ḽφ
+RZPHGLFDȽ2VWHRQLFVȽ6WU\NHUȽ7ULDWKORQȾᡶᴿެԌ୼ḽᡌᵃࣗ୼ḽൽѰެᤛᴿ㘻Ⲻ୼
ḽૂᵃࣗḽ䇦Ⱦ
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ᢃᴿ᭾Ⱦ
с㺞ࡍ࠰+RZPHGLFD2VWHRQLFV&RUSӝ૷ḽㆴрֵ⭞Ⲻ㕟ߏ䈃φ
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!QIN4419 REV A.indd   83
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


㩆ዪ#Nruhdq
KRZPHGLFD#RVWHRQLFV#WULDWKORQ#WULWDQLXP#⬮ⳮ#➖≪#LIX
☎Ὧ
Krzphglfd#Rvwhrqlfv#Frus1⠂#⛮⢮#⍖ඪ⢲#Wuldwkorq#Wulwdqlxp#ᵊ⠞⍎㖶ᢲ⠞㍢ጾ#
Wuldwkorq#㖮ᠦ⠞᫢ᩖ#ඊඪ⢲#Ꭺ㊞Ḫ#『㒖ᆶ㍢/#൧ඒḪ#Ⅷ⠯Ḫ/#ຢᩖඊ#⍖ೆḪ#『㒖ᆶ㍢⛪#
㘒ྂ#⅖❓㘂⚖#ᯞᨸ#ඪ⢲⟮#⛮⢮㠲#⡖ഞ㘂໚#➮㘆#Ꭺⵞ᯦ᤆ#ඊ◲ᓂ♲⍟፲ᎎ1#ಫ#⡏⼂♺#
Ꭺ㘆#㍣⇛⟪#⣆㔲#㔆⩪♺#⇎ᬯᓂ♞#⠲⍟፲ᎎ1#Wuldwkorq#Wulwdqlxp#ᵊ⠞⍎㖶ᢲ⠞㍢ጾ#
⢻㘓⣆ᨦ#⅖❓#ᚺጾ#⅖❓㘂⩪#◴ඊ#⢫❓㘂ᑮᤇ#㔆໚ᓂ♞#⠲⍟፲ᎎ1#
Ꭺ㊞Ḫ#『㒖ᆶ㍢=#Wuldwkorq#Wulwdqlxp#ᵊ⠞⍎㖶ᢲ⠞㍢ጾ#Wuldwkorq#⎗⠺⠢Ꭺ#ᶞ⤞+FU,#Ჹ#
⎗⠺⠢Ꭺ#⢲⣆+㝮᳓#◲⢿㛾#0#SV,#ᖾ⠺⠢ඦ#㛢㜂ᓓ፲ᎎ1#
൧ඒḪ#『㒖ᆶ㍢=#Wuldwkorq#Wulwdqlxp#ᵊ⠞⍎㖶ᢲ⠞㍢ጾ#⎗⠺⠢Ꭺ#ᶞ⤞+FU,/#㝮᳓#
◲⢿㛾+SV,#Ჹ#ඪ⢲ถ#◲⢿㛾+FV,#ᖾ⠺⠢♺⇆#Wuldwkorq#൧ඒḪ#Ⅷ⠯Ḫ⛪#㛢㜂ᓓ፲ᎎ1#
൧ඒḪ#Ⅷ⠯Ḫጾ#⚖ᢖ#⤯ᨂ⠂#ᓺྂ⛪#ᎎ☻㘆#◿Ჿ#⢿ᑮᤆ#⣆ඟᓓ፲ᎎ1
Ⳣඊ=#Wuldwkorq#Wulwdqlxp#᳚⠞⍎㖶ᢲ⠞㍢ጾ#⠮㏓㇚#㏒ᖆ⛪#㘒ྂ#⣆ඟᓓ፲ᎎ1#⠮㏓㇚#
㏒ᖆጾ#൧ඒḪ#ᵊ⠞⍎㖶ᢲ⠞㍢#◿⠯#᎒൮♺⇆᩶#⅖❓㘞☦#㘂ඊ/#◿⠯⠞#⛮᥶ᓆ#㝮♺ጾ#
㑺໚㘞☦#㘓፲ᎎ1#⠮㏓㇚#㏒ᖆᨦ#⠮㖶ᠦ㍢♺#⅖❓㘂⩪#ᩲ⎗⎆⛎1
⍖ೆḪ#『㒖ᆶ㍢=#⍖ೆḪ#⼂㜂#『㒖ᆶ㍢ጾ#᭒ᖊ#㖶ᠦ⍎㎛#Ꭺ⼗#Ჹ#ỮᎪ⼗/#ຢᩖඊ#᫾ㅲ᳛#
ᖾ⠺⠢♺#⅖❓㘊#⋂#⠲⍟፲ᎎ1#⍖ೆḪ#『㒖ᆶ㍢ᨦ#⇊ㆇ⢫⟦ᤆ#⅖❓㘂⎗⎆⛎1#Wuldwkorq#
Wulwdqlxp#ᵊ⠞⍎㖶ᢲ⠞㍢ጾ#᭒ᖊ#Wuldwkorq#⍖ೆḪ#『㒖ᆶ㍢⛪#㛢㜂ᓓ፲ᎎ1#
Ⲗᶶ

DVWP#I0:8#⿾᳆㍢#ㄖᤖ#㘓າ
Ꭺ㊞Ḫ#『㒖ᆶ㍢

DVWP#I0<3#⿾᳆㍢#ㄖᤖ#㘓າ
൧ඒḪ#Ⅷ⠯Ḫ❓#ඊ⢿#⛪⠞♞

DVWP#I0486:#⿾᳆㍢#ㄖᤖ#㘓າ
Ꭺ㊞Ḫ#㑂ຢ

DVWP#I0469#㎚ㅪጮ#㘓າ
൧ඒḪ#『㒖ᆶ㍢

DVWP#I09:#FS#㎚ㅪጮ
൧ඒḪ#『㒖ᆶ㍢

DVWP#I044;8#⠢⅚#⼦⍂
Ꭺ㊞Ḫ#『㒖ᆶ㍢/#⍖ೆḪ#『㒖ᆶ㍢

DVWP#I097;#ⶲඊḮ⠺ᡳ#
㒞ᩖ♺㎢ᢶ
൧ඒḪ#ᵊ♞ᩫ#Ⅷ⠯Ḫ/#⍖ೆḪ#『㒖ᆶ㍢
Ⳬⰻ+⺇,
⠦᳂#⛮⢮#⍖Ḫ#⠢ඟ#ඪ⢲⋊+WNU,♺#Ꭺ㘆#⢫⟻⩇=

# ᯞᨸ⠂#㉟⩇/#⡏☊ᤆ#⠢㘆#ඪ⢲⚦⠂#❺⠢⟪#ᎎ⟶ඦ#ೃ⍟፲ᎎ=#Ữ⚦⩇⇛#㊞㘳⇛#ඪ⢲⚦
+ᾲඪ⢲⚦/#✢Ⅻ⇛#ඪ⢲⚦#ᚺጾ#ᯞ㚲⇛#ෞ⅖#㒖㘒,/#ᨂᩲ㎚⍎#ඪ⢲⚦#ᚺጾ#✢Ⅻ#㝮#
ඪ⢲⚦1

# ✢Ⅻ㝮#ᯞᨸ#ඪ⢲#᳚⼂ᅂ#໚ፏ⠂#Ⅻ⎎

# ⠢Ꭺ#ถ⤚ಪ#⢫㘓㘆#໚ፏඦ#◲⢿⇛⟦ᤆ#㜶ᶟᓊ#ಪፏ⇛⠞#⠲ጾ#⦻ᖛ#ᅞ᳂⤛/#✢᳂⤛/#
㛣⟪#พඋ#໚㚿1
!QIN4419 REV A.indd   84
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT



# ⇛ඟ⢫⠞⩪#᭥㘆#⍖Ḫ#෺ⵞ#ᚺጾ#໚ㅪ#ⵂ⼂♺#Ꭺ㘆#෺⢿1

# 㔆⦪#ඒ⢲#ඪᩖ#໚ᴿ⟦ᤆ#◲⢿㛾⎆ㅖ#⋂#♰ጾ#Ꭺ㊞ඒ#❺➮Ḫ#Ჹ2ᚺጾ#຦➮#൧ඒ⠂#ඒ⢲
Wuldwkorq#Wulwdqlxp#↊ⱞ➎㧶ᳲⱞ㞢᝾#⳻ㄓⴆṦ#▖⮓#᫺᝾#▖⮓㩂⺪#⨴᝾#ᆧ⮚⪺#
▖⮓㩓ឲ៎1
㝮᳓#◲⢿㛾+SV,#『㒖ᆶ㍢❓#⸾ಪ#⢫⟻⩇

# ⩇ಪᓆ#◿Ჿ⟦ᤆ#⠞⎇#ᵊ♞ᩫ#㔆ᬞ⠂#໚㘂㘃⢫#᳚⚞⟮#✾ถ㘂ጾ#⠢Ꭺ⠂#Ḳ◲⢮⇛1

# 㝮᳓#⎗⠺#⠢Ꭺ⠂#Ḫ⡖ᅂ#ᩲỮ1

# ⎖ಫ㘆#ᯞᨸ#ඪ⢲⠂#⢮㝮#Ḳ◲⢿⇛1
ዲጚ

# ⍖Ḫ#ඪ⢲#ᅞḪᅂ#⦦➮⠂#㜆⇛#ᚺጾ#⠂⎖⠞#ಪጾ#⡊⡖#಺⚦1#

# ಺⚦#Ḫ➮ಪ#᫦#൧❚#㚲㘳⇛#಺⚦⠞#⠞⎇#Ḫ➮ᤆ#ᴲ⩲#⋂#⠲⍟፲ᎎ1#

# ᶞⵊ#Ḳ◲⢿/#ᶞⵊ#ඊ⢿#⎎㏒#ᚺጾ#⋂⋊㝮#⩮᥶⠂#㘓ᵻ⩇⟦ᤆ#⠢㘂⚖#⼂ᬯ⢫⠢#➮㚂⟮#
ⶲᡂ㘊#⋂#⠲ጾ#⢿⎊⢫#㛣⟪#⎊൧຦⟋⇛#⡏☊1#

# ⩲ᵻ#Ჹ#಺⚦#ᚺጾ#ᶞⵊ♺#◲⢿⢫⠢#⩪⩪#Ჹ#ඊ⢿⠞#൚⚖ᓆ#໚⤞#⠮㖶ᠪ㍢♺⇆#໚⠢㘆#
ᾲ#⍎㉋⠂#∺Ⅻ1#

# ඒ൓⠂#Ტ⇛⋃1#

# ൫⠢Ꭺ#ถ⤚ᅂ#໚ፏ#Ḫ⡖♺#ᗚᨢ#⎖ಫ㘆#⠞Ⳓ⢫#ᯞᨸ#ඪ⢲#Ḳ◲⢿⇛1#

# Ữ᩶1#ඦⵞ⦻⠞ᅂ#Ữ᩶#㜂⠺ጾ#⡏⼂⠂#ඊ⡏⟮#⟊᳆㘊#⋂#⠲ጾ#ᶞⵊ⠂#ඦḪ㘂ᨦ#ⶲᡂ㘊#
⋂#⠲⍟፲ᎎ1#
ⷦⱂ#

# ⠂⅖ጾ#⡖ഞ#⋂⋊⠂#㘆൮⛪#⢫⢲㘆#ඊ⢿ඦ#㜶ᶟ#⢮໶⩪#⠞⎇᯦♺#⢮ⵞ#ⵞ⦻⟮#ಪ㘂⩪#
◴ശ#ᶞ㛢㘞☦#㘂ጾ#㗮✾⇛⟮#㜂⠺♺ശ#◶ᣎ☦#㘓፲ᎎ1#ඪ⢲#Ꭺ⼂♺#⚫㙏⟮#⦦ጾ#
ඦᑮ㘆#❞ᒃ⠞ᅂ#✢Ⅻ⟪#⠂⩪#⠞⎇᯦⠂#⠞⛮/#㎶⚞#ຢᩖඊ2㛣⟪#ᩲ᭒♺#⠂㘞#⡖ഞ#
⋂⋊⠂#⎎㏒ᨦ#ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1#『㒖ᆶ㍢⠂#⠞⛮⟪#ᩲ᭒#⠯⠺ಪ#᏾#᩸⠞#ↇ໚ശ#
㘊#⁺᩶#◮፲ᠦ#෺⢿#⋂⋊⟮#⎎㏒㘂ശ#᩶ᖆጾ#ᾲ#∺Ⅻ⟮#ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1

# 㜂⠺ጾ#㜆ᒃ⟮#♟⣆㘂ඊ#Ꭺ⼂ᓆ#ඪ⢲♺#Ḳ㗮✾㘆#◿Ჿ⟮#⦦⩪#◴ᑮᤇ#⤚⎖㘞☦#㘂ᬚ#
⸾⢫#പ⅖⛪#⩮᥶♺#ඪ㘆#⠂⅖⠂#⩪⎆ᨦ#ᗚᠦ☦#㘓፲ᎎ1

# ⋂⋊⠂ጾ#⡏⼂⠂#⟊㘆㘆#⅖❓#⋂ᬯඦ#⠞⎇#⋂⋊#㝮#ᶞ㛢♺#㗮✾㘆#⅖㘗#ᖛ⟮#㒖㘒㘂⚖#
⡊⡖⢫⠢#Ḫ⠻❓♺#ඪ㘞#㜂⠺♺ശ#൧ඊᨦ#㘞☦㘓፲ᎎ1#㜂⠺ጾ#⡏⼂ಪ#⢿Ⅻ⢫⠢#ഞಿ㘆#
ඪ⢲⠂#⟊⚚⇛/#ಿᑮ/#⎊ᥚ⇛#ᚺጾ#ᅞถ⇛⟮#ᶟ⣆㘂ጾ#ഭ⠞#◮፲ඊ#㡂⠞#ಪ㘞⩪ጾ#
❞ᒃ⠞ᅂ#✢Ⅻ♺#⠂㘞#⠞⎇᯦⠞#㎶∺ᓂചᅂ#∺Ⅻᓊ#⋂#⠲ᎎጾ#ഭ⟮#◶◮☦#㘓፲ᎎ1

# ⛮⢮#⍖Ḫ#ถ⇛Ḫ㔲⠂#⢫⢲㘆#⇊ㆇ/#᳚⼂#Ჹ#ඊ⢿⟪#⠮㖶ᠪ㍢#⅖❓#⋂ᬯ♺#⚫㙏⟮#
⦦ጾ#⦻Ꭺ㘆#✾⠢⠯፲ᎎ1#᭒ᖊ#ᶞⵊ#⠮㖶ᠪ㍢⛪#ᩲⳖಪ⩪ᤆ/#⠞#『㒖ᆶ㍢ᖎ⠂#
ᅞถ⇛ᑮ#ᎎ☻㘆#ↇ᯦㘃⢫/#ↇ᯦໚൮⢫#Ჹ#໚ㅪ#✢Ḫ#✾⠢ᖎ⠂#⚫㙏⟮#᳅⟦ᬚ/#⠞ᤆ#
⠢㘂⚖#⅖❓#⋂ᬯ⠞#⣆㘆ᓓ፲ᎎ1#ᗚᠦ⇆#⠞#⣆㔲⠂#⢫⟻⩇ඦ#າ໚/#⦦⠂#Ჹ#൧ඊᨦ#
♮൓㠲#⦪⋂㘂ጾ#ഭ⠞#⅖❓#⋂ᬯ⟮#⚚⡏㘂ጾᐚ#᳂ᖆ⎆#㗮✾㘓፲ᎎ1#
!QIN4419 REV A.indd   85
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT


㭆⮓#⃹#ⱞ⟇

# ㄖ໚⠂#൚⢿/#⎆㚂#಺∶#Ჹ#❞ᒃ#ᴾ➮⠂#㑳ಪ♺ጾ#ึ⡏㘂ጾ#⎆㚂❓#『㒖ᆶ㍢ᨦ#᳂ᖆ⎆#
⅖❓㘂⚖/#⎎⣆#⠮㖶ᠪ㍢⛪#ᬢຊ#㒖⡏⟮#ᶞ⢮㘞☦#㘓፲ᎎ1#

# ⋂⋊⢮♺#『㒖ᆶ㍢#ㄖ໚⛪#⍎ㅪ⠦⠂#⚲⻋♺#ᑮ❪⠞#ᓂጾ#᳓⅖⇊#ⷖ⚫❓#㈆㖶ᩩ⠞#
⣆ඟᓓ፲ᎎ1#

# ⠮㖶ᠪ㍢#Ḫ➮♺⇆#ඒ⇢㑢/#ᾲ#⢻⠻ⵞ#⤚ಫ#Ჹ#າ∷#㎶㑢⟮#⣆ച㘂⚖#㎶㑢ᖎᤆ#⠢㘞#
⠮㖶ᠪ㍢⠂#ඪ⢲ᬞ⠞#ຳ∷㠲#ᩲ᭒ᓂ⩪#◴ᑮᤇ#⦦⠂㘞☦#㘓፲ᎎ1#

# Krzphglfd#Rvwhrqlfv#Frus1⅖⠂#⋂⋊#∶ൖ⇎ᬯ⇆ጾ#ⵂ⼂♺#Ꭺ㘆#⸾ಪ#⇎ᬯ⟮#
⣆ඟ㘓፲ᎎ1#

# ㍣⢿#⣆㔲♺#Ꭺ㘆#㛢㜂⇛♺#ඪ㘞⇆ጾ#⣆㔲#㔆⩪ᨦ#Ⳣඊ㘂⎗⎆⛎1#⠦᳂⢫⟦ᤆ#ᎎ⟶#
⅖㘗⠞#⢫❓ᓓ፲ᎎ=
±
SV#Ꭺ㊞Ḫ♺ጾ#SV#൧ඒḪ#ᵊ♞ᩫ᩶#⅖❓
±
FU#Ꭺ㊞Ḫጾ#FU#൧ඒḪ#ᵊ♞ᩫඦ᩶#⅖❓
±
SV#ᚺጾ#FU#Ꭺ㊞Ḫ♺ጾ#FV#൧ඒḪ#ᵊ♞ᩫ᩶#⅖❓
㭂ⱺṦ#⯮㩆#⳿⇞#

# ⠂⅖ጾ#㜂⠺♺ശ#⡖ഞ#⋂⋊⠂#㘆൮⛪#⢫⢲㘆#ඊ⢿ඦ#㜶ᶟ#⢮໶⩪#⠞⎇᯦♺#⢮ⵞ#
ⵞ⦻⟮#ಪ㘂⩪#◴ശ#ᶞ㛢㘞☦#㘂ጾ#㗮✾⇛⟮#⠢⎇⎆ㅟ፲ᎎ1#ඪ⢲#Ꭺ⼂♺#⚫㙏⟮#⦦ጾ#
ඦᑮ㘆#❞ᒃ⠞ᅂ#✢Ⅻ⟪#⠂⩪#⠞⎇᯦⠂#⠞⛮/#㎶⚞#ຢᩖඊ2㛣⟪#ᩲ᭒♺#⠂㘞#⡖ഞ#
⋂⋊⠂#⎎㏒ᨦ#ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1#『㒖ᆶ㍢⠂#⠞⛮⟪#ᩲ᭒#⠯⠺ಪ#᏾#᩸⠞#ↇ໚ശ#
㘊#⁺᩶#◮፲ᠦ#෺⢿#⋂⋊⟮#⎎㏒㘂ശ#᩶ᖆጾ#ᾲ#∺Ⅻ⟮#ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1

# 㜂⠺ጾ#㜆ᒃ⟮#♟⣆㘂ඊ#Ꭺ⼂ᓆ#ඪ⢲♺#Ḳ㗮✾㘆#◿Ჿ⟮#⦦⩪#◴ᑮᤇ#⤚⎖㘞☦#㘂ᬚ#
⸾⢫#പ⅖⛪#⩮᥶♺#ඪ㘆#⠂⅖⠂#⩪⎆ᨦ#ᗚᠦ☦#㘓፲ᎎ1

# ⠂⅖ጾ#㜂⠺♺ശ#⋂⋊⠂#➮㚂♺#Ꭺ㘞#⦦⠂ᨦ#⦦ඊ#⡊⡖⢫⠢#Ḫ⠻❓♺#Ꭺ㘞⇆ᑮ#
⋃⩪⎆ㅟ፲ᎎ1#㜂⠺ጾ#⡏⼂ಪ#⢿Ⅻ⢫⠢#ഞಿ㘆#ඪ⢲⟮#ᶟ⣆㘂ጾ#ഭ⠞#◮፲ඊ#㡂⠞#
ಪ㘞⩪ጾ#❞ᒃ⠞ᅂ#✢Ⅻ♺#⠂㘞#⠞⎇᯦⠞#㎶∺ᓂചᅂ#∺Ⅻᓊ#⋂#⠲⟦ᬚ#⡏⼂ጾ#
⟊㘆㘆#⋂ᬯ⟮#ಪ⩪ඊ#㙏㝮#෺㜂㘞☦#㘊#⋂ᑮ#⠲ᎎጾ#ഭ⟮#◶◮☦#㘓፲ᎎ1

# ⠦Ⅻ#ↇ㜆♺⇆#⠦ඦ⇛#ຊ㚲⩇⠞#᳆ↇ㘊#⋂#⠲⍟፲ᎎ1#⼂ඦ#⼂᥶/#ᅞ⎆൧#പ⅖#ຢᩖඊ#
໚ㅪ#⠻⟪#⋂⋊#⢲Ⳓጾ#⠦ඦ⇛#ຊ㚲⩇ඦ#ඪᣒ⠞#⠲⟮#⋂ᑮ#⠲⍟፲ᎎ1#⠞⎇#ḪḮ♺#
಺⚦⟮#⚲᳓㘂ᣎᬞ/#⋂⋊#⢮⠞ᅂ#㝮♺#㘗ↇ⣆#⚲᳓ᴿ⟮#⅖❓㘂ጾഭ⠞#㗮✾㘊#⋂#
⠲⍟፲ᎎ1
ᆧᇊ

# ∺Ⅻᓂചᅂ#⡂᭥#⺒ຳᓆ#⠮㖶ᠪ㍢ጾ#᭒ᓺ#㑺໚ⵂḮ#㘂⎗⎆⛎1#

# ⠮㖶ᠪ㍢ጾ#✢ඪⅫ#∺Ⅻᓂ⩪#◴ጾ#ഭⵂᢦ#ᶞ⠞᏾ᠦᑮ#⢲Ꭺᤆ#⡖⅖❓㘂⩪#ᩲ⎗⎆⛎1#

# ⠮㏓㇚#㏒ᖆᨦ#⦦⠯㘂⩪#ᩲ⎗⎆⛎1#⠮㏓㇚#㏒ᖆጾ#൧ඒḪ#◿⠯#᎒൮♺⇆᩶#⅖❓㘞☦#
㘓፲ᎎ1#◿⠯#㖮ᤆ⇢⍎ಪ#ᄇᅂᬞ#⨳⎆#⣆ച㘂⚖#㑺໚㘂⎗⎆⛎1#

# ⠞⎇᯦⠂#ඊරㆇ#ⵂᩖᓆ#ḪḮ⟪#⚚ᩲ⇛⠞#⠲ጾ#㔆ᬞඦ#⢻ⶳᓂ♞⇆ጾ#◲ᓓ፲ᎎ1#

# ᵊ♞ᩫ#ḪḮ⟪#⤚ᩧ#⢮#༒ᄁ㘂ശ#⟊⩪㘂ᬚ#♞ᙊ㘆#⠞᯦⩲⠞#♰ᑮᤇ#ඪᩖ㘓፲ᎎ1#
!QIN4419 REV A.indd   86
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT



# ⠞⎇᯦⟮#ถḪᩖചᅂ#Ữ㍪ᬞ#㗦ᤆ#ಿᑮᨦ#⢪㘂⎆⿆#Ḫ㘂#⎆#ඊ⡏⟮#ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1#

# Ⅷ⠯᯦♺#⠲ጾ#າ∷#ඊ⢿#ᩫ⟪#⤚ᩧⵞ⠂#◲⢮♺#᪎❚#⦻✾㘂ᱪᤆ#᩶⩪ചᅂ#
⣆ച㘞⇆ጾ#◲ᓓ፲ᎎ1#າ∷#ඊ⢿#⛪⠞♞ಪ#∺Ⅻᓂ♲ചᅂ#⡂᭥#⺒ຳᓆ#൧ඒḪ#ᵊ♞ᩫ#
Ⅷ⠯᯦⟪#㑺໚㘂⎗⎆⛎1#⠞#⤚ᩧⵞᨦ#㘒Ḫᤆ#ᎎᦒጾ#൧❚#ඊ⢿#⡏⼂⠂#໚ፏ♺#⚫㙏⟮#
⦮#⋂#⠲⍟፲ᎎ1#

# ᭒⇆ᩖಪ#ᅊ⼞ᤆ❞#⢿㚿✢ඦ#⡏⼂⠂#⺒ຳ#⎆#⋂⋊❓#⡏಻⠞#⢲᎒ᓂ⩪#◴ᑮᤇ#
⦦⠂㘓፲ᎎ1#

# ᬯ⎆ᓆ#⅖㘗⟮#⣆✢㘂ඊጾ/#Krzphglfd#Rvwhrqlfv#Frus1⎇㜶⅖ጾ#Krzphglfd#
Rvwhrqlfv⠂#⛮⢮#⍖Ḫ#『㒖ᆶ㍢ᨦ#ᎎᨢ#⣆⤚♯ⵞ⠂#⛮⢮#⍖Ḫ#『㒖ᆶ㍢⛪#㘒ྂ#
⅖❓㘂⩪#◴ᑮᤇ#ಿᣏ㠲#ึ⡏㘓፲ᎎ1#⠞ᢖ㘆#⅖❓⟪#㛦㘓#『㒖ᆶ㍢#⠮㖶ᠪ㍢⠂#
⇛ፏඦ#ඪᣒ㘂⚖#Krzphglfd#Rvwhrqlfv#Frus1ጾ#⠦ⵞ⠂#⳯⠮⟮#⩪⩪#◴⍟፲ᎎ1

# Krzphglfd#Rvwhrqlfv#Frus1⎇㜶⅖ጾ#Krzphglfd#Rvwhrqlfv#⛮⢮#⍖Ḫ#
『㒖ᆶ㍢ᨦ#ᎎᨢ#⣆⤚㜶⅖⠂#ᾲ#ᅂ⅖⛪#㘒ྂ#⅖❓㘂⩪#᩺#ഭ⟮#ಿᣏ㠲#ึ⡏㘂ጾ#ᐚ/#
⠞ጾ#ᅂ⅖#᫢ᩖ⛪#ᅂ⅖#⎆㍢⠂#ถ⇛♺#Ⳓ⠞ಪ#⠲໚#ᗶᯢ⠯፲ᎎ1#

# ⛮⢮#⍖Ḫ#『㒖ᆶ㍢ᨦ#⠂ᑮ⢫⟦ᤆ#⣆ച㘂ᣎᬞ/#⢲⅗❓#ᴮ⛪#☱ඊ#⤫⟪#⢲ඒᑮᨦ#
⦦⠂㘞⇆#⅖❓㘂ᬚ#㡂⟮#⤚⢲㘂ᬞ#ಪፏ㘓፲ᎎ1#

# າ∷#ᵊ⠞⍎#㖶ᢲ⠞㍢♺#⤚ᩧᓆ#㖶ᠦ⍎㎛#൧ඒḪ#Ⅷ⠯᯦⟮#⠂ᑮ⢫⟦ᤆ#⣆ച㘂ጾ#൧❚#
㖶ᠦ⍎㎛#Ⅷ⠯᯦⠞#㎶ෞᓊ#⋂#⠲⍟፲ᎎ1#Ⅷ⠯᯦#⣆ച⎆#൧ඒḪ#ᵊ⠞⍎#㖶ᢲ⠞㍢⠂#
㔆ᬞ♺#㠊⩻⠞ᅂ#㛲⠞#ↇ໚⩪#◴ᑮᤇ#⦦⠂㘞☦#㘓፲ᎎ1#

# ᬢຊ#㒖⡏♺#ᯢ⣆ಪ#⠲ጾ#⣆㔲⟪#ඟຳ⠺♺ശ#᳂㔲㘂⎗⎆⛎1#Ⲗὢዊ㩂⺪#Ẳ⟗⟆⬎1#
≪ⱻ⮓#

# ⛮⢮#⍖Ḫ#Ꭺ⼂#『㒖ᆶ㍢⠂#໚Ꭺ#⋂ᬯ⟪#⸾⢿㘂໚#♞ᣟ⩪᩶/#⟊㘆㘓፲ᎎ1#⠞#
『㒖ᆶ㍢ᖎ⟪#໚ᒃ⇛⠂#ᶟ❺⠞ᅂ#㉟⩇⠂#಺∶ᨦ#᭓⢫⟦ᤆ#⎊ⵞ♺#Ⅷ⠯ᓂጾ#⠞᯦⩲ᤆ#
⣆⠻ᓓ፲ᎎ1#㘂⩪᩶/#⠞ᢖ㘆#⡏⼂♺#⚫㙏⟮#⦦ᬚ#ↇⵞ#㑳ಪಪ#Ḳಪፏ㘆#ᎎ⋂⠂#
ↇ᯦㘃⢫/#໚൮⢫#Ჹ#᯦ᩖ㛾㘃⢫#✾⠢ᖎᤆ#⠢㘞/#『㒖ᆶ㍢ᖎ⟮#㉟㘆#㜆ᒃ#⋂⦪♺ጾ#
㘆൮ಪ#⠲ඊ#⢿Ⅻ⠢⠂#ഞಿ㘆#ᾲ⛪#ೃ⟪#໚ፏ⟮#⋂㘳㘂໚♺ጾ#ᯞᩖಪ#⠲⍟፲ᎎ1#✢ඦ#
⠂⅖ጾ#⠞#⡏⼂⠂#⋂ᬯ♺#ඪ㘞#㜂⠺ᖎ⠞#㚮⎎⢫⠢#໚Ꭺ಺⟮#ೀᑮᤇ#⇎ᖇ㘞☦#㘓፲ᎎ1

# Ꭺ㊞Ḫ/#൧ඒḪ/#㛣⟪#⍖ೆḪ#ᶞⵊ⠂#⢮➮ጾ#㜂⠺⠂#Ḫ⢫⢲㘆#㜆ᒃ⠞ᅂ#✢Ⅻ#ᚺጾ#
ↇ᯦໚൮⢫#⅖㘗♺#⠂㘞#᳆ↇ㘊#⋂#⠲⍟፲ᎎ1#

# ⛮⢮#⍖Ḫ#Ꭺ⼂#『㒖ᆶ㍢ጾ#ጺ⍒㘞⩲#⋂#⠲⍟፲ᎎ1#⤚໚♺#᳆ↇ㘂ጾ#໚൮⢫⠢#
ጺ⍒㘒⟪#ⶲ໚⠂#Ḳ⹓Ḯ㘆#ඊ⢿/#⡊⡖#಺⚦/#㛣⟪#ᶞⵊ♺#Ꭺ㘆#⤚໚#Ḫ㘂/#『㒖ᆶ㍢#
Ḫ⢿㚿/#㛣⟪#✢Ⅻ♺#⠂㘞#ⶲᡂᓊ#⋂#⠲⍟፲ᎎ1#⸾㝮⠂#ጺ⍒㘒⟪#✢Ⅻ/#಺⚦/#ඒ❓㘞#
ᖛ⠂#ↇ᯦㘃⢫#㘓ᵻ⩇/#ᾲ⠂#Ტᠪ#Ჹ2ᚺጾ#㉟⩇⟮#⋂᳂㘊#⋂#⠲ጾ#໚൮⢫#ᯢ⣆ᑮ#
ⶲᡂ㘊#⋂#⠲⍟፲ᎎ1#

# ൧ඒḪ/#Ꭺ㊞Ḫ#ຢᩖඊ#⍖ೆḪ#『㒖ᆶ㍢ᨦ#㒖㘒㘆#⛮⢮#⍖Ḫ#『㒖ᆶ㍢⠂#㗦ᤆ#㎶᎒⠞#
⠻⟪#Ữ⟒⠞⩪᩶#᳆ↇ㘲⍟፲ᎎ1#㘂Ḫ#ᾲ⠂#Ḫ⢫⢲㘆#⩪⩪#㛣⟪#『㒖ᆶ㍢#ඊ⢿#
Ḫ⤛⟦ᤆ#⠢㘞#⍖Ḫ#『㒖ᆶ㍢⠂#㎶᎒⠞#᳆ↇ㘊#⋂#⠲⍟፲ᎎ1#
!QIN4419 REV A.indd   87
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT



# ᩺ⶲ#⎊൧ᵻ⩇/#⎊൧#∺Ⅻ/#⋆㜂൮#∺Ⅻ⠞#ⶲᡂᓊ#⋂#⠲ඊ#⠞∶⇛#ᾲಪ#㚿⇛ᓊ#⋂#
⠲⍟፲ᎎ1#

# ᭒ᖊ#⛮⢮#ඪ⢲#⼂㜂⋊♺ጾ#⎖ಫ㘆#㘓ᵻ⩇⠞#ⶲᡂᓊ#⋂#⠲⍟፲ᎎ1#⠞ᢖ㘆#㘓ᵻ⩇♺ጾ#
Ữኒↇ⎇໚#⡏☊/#➮⡏#⡏☊/#㚲⢮#ᖛ⠂#㚲ඪ#⡏☊/#ⅳ⢮#ᖛ⠂#໚ඪ⩪㑺#⡏☊/#
⎖⡏ᩲỮᅂ#⅖᪇⠞#㒖㘒ᓂ⩪᩶#⠞ᤆ␒#⣆㘆ᓂ⩪ጾ#◴⍟፲ᎎ1#

# 㒞ᩖ♺㎢ᢶ#『㒖ᆶ㍢⠂#ᩲ᭒ಪ#᳆ↇ㘊#⋂#⠲⟦ᬚ#ᾲ⠂#⡖㠋⋂#⠻❓ඦ#⛮㛾/#಺⚦♺#
⠂㘆#ഭ⟦ᤆ#᳇㚪⣶⍟፲ᎎ1#

# ඪ⢲#Ꭺ⼂#⠞㝮#າ∷#Ღ಺⇛#᳂⟻⠞#ᶞඊᓂ♲⍟፲ᎎ1#

# Ḫ⠻❓⟦ᤆ#⠢㘞#⡖⋂⋊/#෺⢿/#㘞Ꭳ#ඪ⢲⠂#ඊ⢿#Ჹ2ᚺጾ#⅖⩪⠂#⢲᎒⠞#㗮✾㘊#⋂#
⠲⍟፲ᎎ1#

# ⚚Ḫ#⤚⩫⠂#☧㛾#Ჹ2ᚺጾ#⠞⛮⟪#『㒖ᆶ㍢⠂#Ḳ⠦⼂⛪#⚚ඪᓂጾᐚ/#⠞#൧❚#
⠮㖶ᠪ㍢ಪ#⤚໚♺#ᩲ᭒ᓂചᅂ#⣆Ꭺᤆ#ⳓⅫᓂ⩪#◴⟮#⋂#⠲⍟፲ᎎ1#

# ᭒ᖊ#⠮㖶ᠪ㍢#⡏⼂♺⇆ጾ#ᶞⵊ#『㒖ᆶ㍢#⦦➮♺#⠺ಫ⩇Ⅻ⠞#♰ጾ#ทḪ⢫#ᾲ⠂#
⡖㠋⋂+ඒ❓㘞,ಪ#᳆ↇ㘊#⋂#⠲⟦ᬚ/#⠞ጾ#⎆ᬂ㍢#⠯⠺/#າ∷/#ⶲඊḮ⠺ᡳ#㒞ᩖ♺㎢ᢶ#
+XKPZSH,#Ჹ2ᚺጾ#⇢ᠦᲣඦ#⠞᯦⩲⠞#⠻❓㘂⚖#ᅂㅪᅆ#൚ඦ⠯፲ᎎ1#『㒖ᆶ㍢ᖎ#
⅖⠞ᅂ#『㒖ᆶ㍢⛪#ᾲ#⅖⠞⠂#Ⅻ㛢⠻❓♺#⠂㘞#⠯Ⅻ#᯦⩲⠞#ↇ⇛ᓂᬚ/#⠦Ⳓ⢫⠢#ᩲ᭒#
໚⢮⟪#⢻ⳓ/#⢻ⶳ#ᩲ᭒#Ჹ#㗦ᤆ⠯፲ᎎ1#ᚺ㘆/#⠯⠺ጾ#ᎎᨢ#᯦ⵞ⛪#⢻ⶳ#⎆#ᩲ᭒ᓂ♞#
ↇ⇛ᓊ#⋂#⠲⍟፲ᎎ1#ඒ❓㘞ጾ#☈⟦ᤆ#㘓ᵻ⩇⟮#⟊᳆㘊#⋂#⠲⟦ᱪᤆ/#⠞ᢖ㘆#൧❚#
ᶞⵊ#『㒖ᆶ㍢⠂#⣆ച⛪#⼂㜂⠞#㗮✾㘂ശ#ᓓ፲ᎎ1#

# ⢿Ⅻ⢫⠢#⅖❓ඦ#⎆ಮ⠂#൧ඦ♺#ᗚᠦ⇆#າ∷#Ჹ#㒞ᩖ♺㎢ᢶ#『㒖ᆶ㍢ᤆḪ㇚#᪎❚#
⠻⟪#ㄖ໚⠂#⠯⠺ಪ#ᙒ♞⣢#ᅂ⛖#⋂#⠲ᎎඊ#◶ᣎ⣢#⠲⍟፲ᎎ1#ᎪḪḮ⠂#Ḫ⍎ᢖ໚ᖎ⠞#
⚚ඪ#ඪ⢲♺#ᅒചᅂ+⚲=#㜆ᩳ♺#ᖎ♞಺,#⦦ᵪ⠂#㗦Ḫ#⤚⩫♺#ᔂᢖ⎢⠞᏾ᠦᑮ/#Ტ⇢#
⠯⠺ᖎ⟪#ඪ⢲#᳀⟦ᤆ#⠞ᒃ㘂⚖#⎊ⵞ⠂#ᎎᨢ#ḪḮ⟦ᤆ#⛘൒ಲ#⋂#⠲⍟፲ᎎ1#㚮⡖/#
⠞ᢚ#『㒖ᆶ㍢♺⇆#ↇ⇛ᓊ#⋂#⠲ጾ#Ḫ⍎ᢖ໚#Ჹ#Ტ⇢#⠯⠺ᖎ♺#ඪ㘞#ᬯ㛿㘆#⠞⟊ጾ#
᳇㚪⩪⩪#◴☂⍟፲ᎎ1#Ტ⇢㘆#Ḫ⍎ᢖ໚#⠯⠺ᖎ⟪#⎊ⵞᨦ#㉟㘞#᳓⹆ᓊ#⋂#⠲ඊ/#൧❚♺#
ᗚᠦ#ᩦ㖮⢲#Ჹ#⎊ⵞ⠂#ᎎᨢ#Ḫ➮♺#⸿⢫ᓂጾ#ഭ⟦ᤆ#◶ᣎ⣢#⠲⍟፲ᎎ1#◮⩫໶⩪#⠞ᢚ#
⠯⠺ᖎᤆ#⠢㘞#⎖ಫ㘆#⠂㘃⢫#㘓ᵻ⩇⠞#ᶞඊᓆ#⢫⟪#♰♲⩪᩶/#⎊ⵞ#∷⟦ᤆ#⠞⢮#Ჹ2
⸿⢫ᓂጾ#൧❚ጾ#⚖ᢖ#ᯢ㙶♺#♢ຳᓂ♞#⠲⍟፲ᎎ1#⠞ᢖ㘆#⡏⼂ಪ#⠞⎇ᓆ#㜂⠺♺#Ꭺ㘆#
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!QIN4419 REV A.indd   88
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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
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
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⣆㔲⟪#᭒ᓺ#㑺໚㘂⎗⎆⛎1#

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!QIN4419 REV A.indd   89
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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!QIN4419 REV A.indd   90
4/8/2013   1:07:28 PM
r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT

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日本語 Japanese
HOWMEDICA OSTEONICSのTRIATHLON TRITANIUM人工全膝関節 取扱説明書
概要
Howmedica Osteonics Corp.の人工全膝関節システムは、膝関節の再建全置換のため
に、Triathlonプライマリー膝関節システムの大腿骨コンポーネント、脛骨インサート、および膝
蓋骨のコンポーネントと併用するよう設計されている、Triathlon Tritanium (トライアスロン・ト
ライタニウム)ベースプレートが含まれています。各器具固有の特長は、その製品ラベルで詳細
されています。Triathlon Tritaniumベースプレートはセメントレス固定およびセメント固定の両
方での使用に適用されます。 
大腿骨コンポーネント: Triathlon Tritaniumベースプレートは、Triathlon十字靭帯温存型(CR)、
および十字靭帯切除型(後方安定型 ‒ PS)のものと適合性があります。 
脛骨コンポーネント: Triathlon Tritaniumベースプレートは、Triathlon十字靭帯温存型(CR)、後
方安定型(PS)、および顆部安定型(CS: condylar stabilizing)のものと適合性があります。脛骨イ
ンサートには広範囲の厚さと様々な抑制力のものがあります。 
注記:　Triathlon Tritaniumベースプレートにはインパクターパッドが同梱されています。イン
パクターパッドは脛骨ベースプレート嵌入手順中のみに使用し、嵌入が完了したら破棄しなけ
ればなりません。インパクターパッドは植え込み用ではありません。 
膝蓋骨コンポーネント:　: 膝蓋骨関節面再建コンポーネントは、純プラスチック製の対称・非
対称、および金属で裏打ちされたのものがあります。膝蓋骨コンポーネントの使用は任意で
す。Triathlon TritaniumベースプレートはすべてのTriathlon膝蓋骨コンポーネントと適合性が
あります。 
材質

ASTM F-75 コバルトクロム合金
大腿骨コンポーネント

ASTM F-90 コバルトクロム合金
脛骨インサート用ロックワイヤ

ASTM F-1537 コバルトクロム合金
大腿骨ペグ

ASTM F-136 チタン合金
脛骨コンポーネント

ASTM F-67 CPチタン
脛骨コンポーネント

ASTM F-1185 リン酸カルシウム
大腿骨コンポーネント、膝蓋骨コンポーネント

ASTM F-648 超高分子量ポリエチレン
（UHMWPE）
脛骨ベアリングインサート、膝蓋骨コンポーネ
ント
適用
人工膝関節全置換手術(TKR)の一般的な適用::

 非炎症性変形性関節症(変形性関節炎、外傷後関節炎、または虚血壊死を含む)、リウマチ
関節炎、または外傷後関節炎から発生する苦痛を伴い動かすことのできない膝関節の疾
患がある場合。
!QIN4419 REV A.indd   91
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Print Date: Dec 12, 2013 21:25:41 GMT



 外傷後の膝関節の形状および機能を損失した場合。

 靭帯構造を適正な機能と安定性に戻し得るような中程度の内反、外反または屈曲の変形
がある場合。

 以前に行った人工膝関節置換、またはその他の手術が不成功に終わったためその調整を
行う場合。

 標準的な骨折管理法で安定できない大腿骨遠位部および/または脛骨近位部の骨折があ
る場合。
Triathlon Tritaniumベースプレートはセメントレス固定とセメント固定の両方での使用を意図
しています。
後方安定型(PS)コンポーネントに関するその他の適用:

 抑制力を強化した移植ベアリング表面幾何学形状を必要とする不安定な靭帯である場合。

 後十字靭帯が不在であったり、機能が喪失している場合。

 膝関節の前後方が著しく不安定な場合。
禁忌

 膝関節内部または周囲に現在感染症があったり、潜伏性感染症の疑いがある場合。 

 移植部位に血行性散布の原因となる遠部感染病巣がある場合。 

 プロテーゼの不安定化、プロテーゼの固定失敗、または術後の看護における合併症などの
容認できない危険をもたらす精神的または神経筋肉的な障害がある場合。 

 ボーンストックに疾病や感染症があったり、前回の移植のために適切にプロテーゼに支
持、固定できない場合。 

 骨格が未熟な場合。 

 側副靱帯の完全性と機能の喪失により続発した膝関節に重度の不安定性がある場合。 

 肥満症のある場合。体重過多または肥満の患者はプロテーゼに負荷をかけることがあり、
プロテーゼの固定失敗またはプロテーゼの故障につながることがあります。 
術前注意

 外科医は、患者に、再建術の限度と、適切に固定され治癒されるまでインプラントに完全に
体重をかけないため保護が必要であることの2点について指導する必要があります。置換
関節に影響する過度の活動および外傷は、プロテーゼインプラントの緩み、破損、摩耗によ
り再建術の失敗に関係しています。コンポーネントが緩むと、摩耗粒子の発生増加や骨へ
の損傷が生じ、修正手術の成功がさらに困難となります。

 外科医は、活動を制限し、置換関節を不適切な応力から保護し、さらに術後のケアや治療
について医師の指示に従うよう、注意を促す必要があります。

 外科医は、器具の耐用寿命の有限性および術後におけるインプラントの保護の必要性を
含め、潜在的な副作用について患者に警告すべきす。この器具が正常で健康な関節の柔
軟性、強度、信頼性、または耐久性を再現するものでないこと、また過度の活動や外傷の結
果インプラントが壊れたり損傷したりすることを外科医は患者に警告すべきです。
!QIN4419 REV A.indd   92
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r. A ECN Release Date: Apr 30, 2013 1:15:55 PM
Print Date: Dec 12, 2013 21:25:41 GMT



 人工膝関節コンポーネントの適切な選択、設置、および固定は、インプラントの耐用年数に
影響する重要な要因です。すべてのプロテーゼ移植について言えることですが、これらの
コンポーネントは生物学的、生体力学的、および外来性のさまざまな要因に影響され、耐
用年数が制限されます。したがって、耐用年数を最大限にするためにこの製品の適用、禁
忌、術前注意、および警告に厳格に従うことが重要です。 
使用と移植

 サイズの決定、試験的な整復、可動域の評価を行うために、推奨された試験的コンポーネ
ントを必ず使用してください。 そうすることで実際のインプラントおよび滅菌包装の完全
性を維持することができます。 

 コンポーネントサイズとスタイルの術前予測に役立つようX線撮影テンプレートが利用で
きます。 

 破片によるインプラントの関節面の磨耗が加速するリスクを減らすために、移植部位から
骨欠片、骨セメント片、および金属破片を除去するよう注意してください。 

 Howmedica Osteonics Corp.のSurgical Protocols （手術プロトコル）に、処置に関する詳
細が記載されています。 

 特定の製品適合性については製品ラベルをご覧ください。一般に下記の事項が当てはまり
ます。
±
PS大腿骨はPS脛骨ベアリングのみと併用してください。
±
CR大腿骨はCR脛骨ベアリングのみと併用してください。
±
PSまたはCRの大腿骨はCS脛骨ベアリングのみと併用してください。
患者のための情報

 外科医は、患者に、再建術の限度と、適切に固定され治癒されるまでインプラントに完全に
体重をかけないため保護が必要であることの2点について指導する必要があります。置換
関節に影響する過度の活動および外傷は、プロテーゼインプラントの緩み、破損、摩耗によ
り再建術の失敗に関係しています。コンポーネントが緩むと、摩耗粒子の発生増加や骨へ
の損傷が生じ、修正手術の成功がさらに困難となります。

 外科医は、活動を制限し、置換関節を不適切な応力から保護し、さらに術後のケアや治療
について医師の指示に従うよう、患者の注意を促す必要があります。

 外科医は、手術の危険性および可能な副作用について患者に警告してください。この器具
が正常で健康な関節と同じではないこと、過度の活動や外傷の結果インプラントが壊れた
り損傷したりすること、さらにこの器具には有限な使用寿命があり将来置換えの必要があ
ることを、患者に警告しなければなりません。

 日常生活において一過性菌血症が発生することがあります。歯科処置、内視鏡検査、および
その他の小手術も一過性菌血症と関連付けられています。移植部位における感染を防ぐ
には、そのような手順前後に抗生物質による予防法の使用が望ましいことがあります。
警告

 損傷があったり、取り扱いを誤ったインプラントは処分してください。 
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

 損傷がないように見えても、絶対にインプラントは再使用しないでください。 

 インパクターパッドを植え込まないでください。インパクターパッドは脛骨嵌入手順中のみ
に使用するためのものです。嵌入手順後は直ちに取り出し廃棄してください。 

 研磨済みベアリング部分は固い表面や摩耗性表面とは接触させないでください。 

 組立て前に、必ずベアリング部分をきれいにし、微粒子がついていないようにしてください。 

 インプラントを変形したり折曲げたりすると耐疲労強度が減少し、負荷がかかった際に故
障の原因となる場合があります。 

 インサート上の金属製保持ワイヤはアセンブリの固定に重要なので、いじったり取り外し
たりしないでください。金属製保持ワイヤが損傷していたり誤った取り扱いがなされたりし
た場合は、脛骨ベアリングインサートを廃棄してください。このアセンブリをみだりにいじる
と保持機構が正常に機能しなくなる可能性があります。 

 鋭利な整形外科器具を取り扱う際には外科用手袋に穴が開かないように注意してください。 

 特記している場合を除き、Howmedica Osteonics Corp.は他社の人工全膝関節コンポー
ネントをHowmedica Osteonicsの人工膝関節コンポーネントと併用することは是非とも避
けるようにお願いしています。そのような併用の結果発生する混合コンポーネントのイン
プラントの性能に関してHowmedica Osteonics Corp.は一切責任を負いません。

 Howmedica Osteonics Corp.は、ネジ頭とネジ台座の構造に違いがあるため、他社の骨ネ
ジをHowmedica Osteonicsの人工全膝関節コンポーネントと併用することは是非とも避
けるようにお願いしています。 

 人工全膝関節コンポーネントを故意に除去するには、切断バーおよび薄型で幅の狭い骨
切りのみを注意して使用し、慎重に引っぱっると摘出できます。 

 プラスチック製脛骨インサートを金属製ベースプレートに組み込んだ後で故意に取り外そ
うとするとプラスチック製インサートは壊れます。インサートを取り外す際、脛骨ベースプ
レートの表面に傷を付けないように気を付けてください。 

 無菌バリアに欠陥のあるものはすべて供給業者に返品してください。再度滅菌しないでく
ださい。 
副作用

 膝関節全置換コンポーネントの耐用寿命の予測は困難ですが、永久ではありません。これ
らのコンポーネントは可動性の回復および痛みの減少のために体内に設置される異物で
できています。しかし、これらのコンポーネントに影響を与え、体内で評価できない生物学
的、機械的、および生理化学的な要因のために、コンポーネントが通常の健康な骨にかか
る活動と負荷に無限に耐えるものと期待することはできません。外科医は患者に器具の耐
用寿命に対して非現実的な期待を持つべきではないことを助言すべきです。

 不適切な患者の活動、外傷、またはその他の生体力学的配慮事項により人工の大腿骨、脛
骨、または膝蓋骨のプロテーゼの転位が起こる場合があります。 

 人工膝関節コンポーネントの緩みが生じることがあります。初期における不適切な固定、
潜在的な感染、早期のプロテーゼ負荷、コンポーネントの不良配列、または外傷から早期
の機械的緩みが生じることがあります。外傷、感染、骨溶解を含む生物学的合併症、または
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機械的な問題から後期の緩みが生じることがあり、その結果骨の浸食、痛みが生じることが
あります。 

 わずかな割合ですが、脛骨、大腿骨、膝蓋骨のコンポーネントを含む膝関節コンポーネン
トの疲労破損が起こることがあります。膝関節コンポーネントの破損は、その下の骨の支
持が不十分であるか、またはコンポーネントの固定が不良であるために発生することがあ
ります。 

 末梢神経障害、神経損傷、血行障害、および異所性骨形成の弱体化が発生することがあり
ます。 

 深刻な合併症はどんな人工関節全置換手術にも生じる可能性があります。これらの合併
症には、尿生殖器障害、胃腸障害、血栓を含む血管障害、塞栓を含む気管支肺障害、心筋梗
塞、または死亡などがありますが、これらだけには限定されません。 

 ポリエチレン製コンポーネントの摩耗が生じたことがあり、文献によるとこれは骨の再吸
収、緩み、および感染と関係があると報告されています。 

 関節置換後の金属過敏反応が報告されています。 

 副作用のために再手術、修正、関与した関節の関節固定術、手足の切断などが必要になる
ことがあります。 

 軟組織の不均衡および/または弛緩はコンポーネントのマルアライメントに関係しており、
その結果インプラントの早期磨耗および/または故障につながる可能性があります。 

 すべてのインプラントについて該当することですが、セメント、金属、超高分子量ポリエチ
レン（UHMWPE）や、セラミックの微粒子に対する異物反応の結果として、無症候性、局所
進行性骨吸収（骨溶解）がプロテーゼコンポーネント周囲に発生することがあります。微粒
子は、おもに粘着、剥離、および疲労の摩耗機構によるコンポーネント同士、およびコンポ
ーネントと骨の間の相互作用により発生します。また、他との摩耗によっても発生します。
骨溶解により、プロテーゼコンポーネントの緩みを含め、プロテーゼコンポーネントの除去
および置換が必要となるような合併症が将来起こることがあります。 

 長期間において通常に使用していると、金属製およびポリエチレン製のコンポーネントか
ら微小な粒子が出ることが知られています｡この破片の大半は(滑膜内に含まれる)関連す
る関節内に残るか、または周囲の瘢痕組織によって閉じ込められますが、ミクロ粒子がそ
の関節から身体の異なる部位に移動する可能性があります。現在、これらのコンポーネン
トから生じ得る破片およびミクロ粒子について解明されていない疑問があります。ミクロ
粒子の破片が全身に播種(移動)し、場合によってはリンパ節および他の部位に蓄積する場
合があることが示されています。これらの粒子が原因となる医学的に有意な合併症は今ま
で報告されていませんが、体内での移動や蓄積については文献で報告されてきました｡こ
れらの器具を使用する患者についての追跡調査期間が十分でなく、これらの器具を現在
若年患者に使用しており、より長期にわたり体内に留まるという事実を考慮すると、これら
の粒子による長期的な影響があったとしても、現時点ではその影響は不明であることを指
摘する必要があります。理論上想定されている長期的影響には下記のものがあります。 
±
癌: 現在、金属製およびポリエチレン製の破片と癌との関係についての科学的証拠
はありません。しかし、その可能性を除外することはできません。 
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
±
リンパ節症および他の組織や臓器内での蓄積: (近位と遠位の)リンパ節内で磨耗に
よる破片が蓄積したといういくつかの報告があります。これらの蓄積が原因となる医
学的合併症または疾患過程は報告されていませんが、診断を円滑にし、疑わしい病
巣や癌病巣などとの混同をさけるため、そのような蓄積が存在することを認識する
必要があります。 
±
全身性疾患: 破片移動と未特定ではありますが全身的な影響との関連があるのでは
ないかという推測が一部にあります。将来のある時点で一部の長期的影響が立証さ
れる可能性がありますが、破片移動と全身性疾患との関連を示す科学的データがほ
とんどないため、これらの器具の利点が、理論上推測された長期的影響についての
潜在的危険性よりも明らかに勝ると思われます。 
磁気共鳴画像診断装置(MRI)との相互作用
Triathlon膝関節システムは、磁気共鳴(MR)の存在する環境内での安全性および適合性につい
て評価されていません。Triathlon膝関節システムは、磁気共鳴の存在する環境内での加熱およ
び移動について試験されていません。 
滅菌

 この全膝関節コンポーネントはガンマ放射線または過酸化水素ガスプラズマで滅菌され
ています。滅菌方法については包装ラベルをご覧ください。 

 開封前に無菌バリアに欠陥がないかすべての滅菌製品の包装を点検してください。そのよ
うな欠陥がある場合、製品は非滅菌と考える必要があります。コンポーネントの使用前に
滅菌包装を一切開封しなくてもよいように、特別の試験的プロテーゼが利用できます。 

 コンポーネントを汚染しないように注意してください。汚染した場合は、この製品を処分す
る必要があります。 

 包装が開封されているが、製品を使用していない場合、コンポーネントは再度滅菌するこ
とはできないので、処分するか供給業者に返品する必要があります。

 ラベルに記載の有効期限後は滅菌包装の妥当性について検証されていませんので､この
日付後は器具を使用してはなりません。

 再度の移植でかけられる物理的力によって器具の物理的完全性、特徴、表面加工などが損
なわれる可能性があるので、単回使用器具は移植後、再度移植できません。また、洗浄・ 
再滅菌手順の妥当性が確認されていないため、再使用器具の滅菌性は保証できません。
注意: 
米国連邦法により本器具の販売または注文は医師によるもののみに限定されてい
ます。 
警告: 
「セメント固定専用」と記載されたコンポーネントは、骨セメントのみを併用して移植
するようになっています。
Stryker Corporation、その部門、または他の法人関係事業体は、Howmedica、Osteonics、 
Stryker、 Triathlonの商標の所有、使用、または申請を行っています。その他すべての商標はそ
れらの各所有者または所持人の商標です。
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CEマーク適合状況および法的製造業者については製品ラベルをご覧ください。CEマークは、製
品ラベルにも表示されている場合に限り有効です。
下表はHowmedica Osteonics Corp. 製品ラベルで使用されている略語リストです。
用語
略語
用語
略語
アルファコード
$/3+&'(
ネック
1.
角度
$1*
オフセット
2))67
度
'(*RU
外径
2'
直径
',$
右
57  
特に深い
;'3
ネジ穴
6&5+/6
特大
;/*(
側
6'(
極小
;60
サイズ
6=(
ヘッド
+'
小
60
高さ
+7
標準
67'
内径
,'
テーパー
735
インサート
,165
厚さ
7+.16
大
/*(
タイプ
7<3
左
  /)7
付き
:
長さ
/17+
なし
:2
中
0('
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Appendix H 
 
Patient Retention Program 

 
 
 
 
 
A prospective, post-market, multi-center study of the outcomes of the 
Triathlon Tritanium Knee System 
 
Patient Retention Program 
 
Program Details 
 
The intent of this program is to provide birthday, holiday, and study surgery anniversary letters to the subjects who are part 
of the study. These letters will be provided to the site by Stryker Orthopaedics, they will thank the subject for his/her study 
participation and serve as a reminder to come in for the relevant follow-up visits. 
 
Additionally, Stryker Orthopaedics is in the process of implementing a Patient Rewards Program as part of the Patient 
Retention Program. The details of this program will be made available when they have been finalized.   
 
Participation in the Patient Retention Program is optional for each study site, and dependent on IRB approval at each site. 
 
 
Orthopaedics 

[Institution Address] 
[City, State, Zip] 
[Phone] 
 
 
 
 
 
[Instutition Letterhead] 
 
 
 
[Today’s Date] 
 
[Subject Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
 
 
Dear [Subject Name], 
 
Congratulations!  
 
Now that you have completed your [X] year visit in the study, you have earned your $[X] 
reward. Please find this reward enclosed. Thank you again for your continued 
participation in the Stryker Triathlon Tritanium Knee Outcomes Study and I look forward 
to seeing you at your future follow-up visits. 
 
 
Sincerely,  
  
 
 
[Study Coordinator Name] 
[Institution Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
[Email} 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

[Institution Address] 
[City, State, Zip] 
[Phone] 
 
 
 
 
 
[Instutition Letterhead] 
 
 
 
[Today’s Date] 
 
[Subject Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
 
 
Dear [Subject Name], 
 
Congratulations!  
 
[Date] is the [X]-year anniversary of your [Left/Right] total knee replacement. Thank you 
for your continued participation in the Stryker Triathlon Tritanium Knee Outcomes Study, 
and I look forward to seeing you for your next follow-up visit. 
 
Sincerely,  
  
 
 
[Study Coordinator Name] 
[Institution Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
[Email} 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

[Institution Address] 
[City, State, Zip] 
[Phone] 
 
 
 
 
 
[Instutition Letterhead] 
 
 
 
[Today’s Date] 
 
[Subject Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
 
 
Dear [Subject Name], 
 
Happy Birthday! Thank you for your participation in the Stryker Triathlon Tritanium Knee 
Outcomes Study. I look forward to seeing you in the office for your future follow-up visits! 
 
Sincerely,  
  
 
 
[Study Coordinator Name] 
[Institution Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
[Email} 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

[Institution Address] 
[City, State, Zip] 
[Phone] 
 
 
 
 
 
[Instutition Letterhead] 
 
 
 
[Today’s Date] 
 
[Subject Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
 
 
Dear [Subject Name], 
 
Happy Holidays! Thank you for your participation in the Stryker Triathlon Tritanium Knee 
Outcomes Study. I look forward to seeing you in the office for your future follow-up visits! 
 
Sincerely,  
  
 
 
[Study Coordinator Name] 
[Institution Name] 
[Street Address] 
[City, State, Zip] 
[Phone] 
[Email} 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix I 
 
Component Listing 

 
Cohort 1 (cementless) Study Device Component Listing: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 1 (cementless) Compatible Ancillary Component Listing: 
Catalog Number 
Triathlon Tritanium Tibial Baseplate 
5536-B-100 
5536-B-200 
5536-B-300 
5536-B-400 
5536-B-500 
5536-B-600 
5536-B-700 
5536-B-800 
Triathlon Tritanium Asymmetric Patella 
5552-L-299 
5552-L-320 
5552-L-350 
5552-L-381 
5552-L-401 
Triathlon Tritanium Symmetric Patella 
5556-L-319 
5556-L-339 
5556-L-360 
5556-L-391 
Catalog Number 
Triathlon PS Beaded Femur with PA 
5516-F-101 
5516-F-102 
5516-F-201 
5516-F-202 
5516-F-301 
5516-F-302 
5516-F-401 
5516-F-402 
5516-F-501 
5516-F-502 
5516-F-601 
5516-F-602 
5516-F-701 
5516-F-702 
5516-F-801 
5516-F-802 
Triathlon CR Beaded Femur with PA 
5517-F-101 
5517-F-102 
5517-F-201 
5517-F-202 
5517-F-301 
5517-F-302 
5517-F-401 
5517-F-402 
5517-F-501 
5517-F-502 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5517-F-601 
5517-F-602 
5517-F-701 
5517-F-702 
5517-F-801 
5517-F-802 
Triathlon CR Conventional Polyethylene Tibial Inserts* 
5530-P-X09** 
5530-P-X11** 
5530-P-X13** 
5530-P-X16** 
5530-P-X19** 
Triathlon CR X3 Tibial Inserts* 
5530-G-X09** 
5530-G-X11** 
5530-G-X13** 
5530-G-X16** 
5530-G-X19** 
Triathlon CS Conventional Polyethylene Tibial Inserts* 
5531-P-X09** 
5531-P-X11** 
5531-P-X13** 
5531-P-X16** 
5531-P-X19** 
5531-P-X22** 
5531-P-X25** 
Triathlon CS X3 Tibial Inserts* 
5531-G-X09** 
5531-G-X11** 
5531-G-X13** 
5531-G-X16** 
5531-G-X19** 
5531-G-X22** 
5531-G-X25** 
Triathlon PS Conventional Polyethylene Tibial Inserts* 
5532-P-X09** 
5532-P-X11** 
5532-P-X13** 
5532-P-X16** 
5532-P-X19** 
5532-P-X22** 
5532-P-X25** 
Triathlon PS X3 Tibial Inserts* 
5532-G-X09** 
5532-G-X11** 
5532-G-X13** 
5532-G-X16** 
5532-G-X19** 
5532-G-X22** 
5532-G-X25** 

 
Cohort 2 (cemented) Control Device Component Listing: 
Catalog Number 
Triathlon Cemented Tibial Baseplate 
5520-B-100 
5520-B-200 
5520-B-300 
5520-B-400 
5520-B-500 
5520-B-600 
5520-B-700 
5520-B-800 
Triathlon Symmetric  Conventional Polyethylene Patella 
5550-L-278 
5550-L-298 
5550-L-319 
5550-L-339 
5550-L-360 
5550-L-391 
Triathlon Asymmetric  Conventional Polyethylene Patella 
5551-L-299 
5551-L-320 
5551-L-350 
5551-L-381 
5551-L-401 
Triathlon Symmetric  X3 Patella 
5550-G-278 
5550-G-298 
5550-G-319 
5550-G-339 
5550-G-360 
Triathlon Asymmetric  X3 Patella 
5551-G-299 
5551-G-320 
5551-G-350 
5551-G-381 
5551-G-401 
Triathlon CR Cemented Femur 
5510-F-101 
5510-F-102 
5510-F-201 
5510-F-202 
5510-F-301 
5510-F-302 
5510-F-401 
5510-F-402 
5510-F-501 
5510-F-502 
5510-F-601 
5510-F-602 
5510-F-701 
5510-F-702 
5510-F-801 
5510-F-802 
Triathlon PS Cemented Femur 
5515-F-101 

 
 
 
 
 
 
 
 
 
 
*Both cohorts utilize the same tibial inserts. 
**(X = 1,2,3,4,5,6,7 and 8) 
 
 
 
 
 
 
 
5515-F-102 
5515-F-201 
5515-F-202 
5515-F-301 
5515-F-302 
5515-F-401 
5515-F-402 
5515-F-501 
5515-F-502 
5515-F-601 
5515-F-602 
5515-F-701 
5515-F-702 
5515-F-801 
5515-F-802