Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Phase: NA
Conditions: Degenerative Spondylolisthesis, Pseudoarthrosis
Sponsor: Zimmer Biomet

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL: 
Post Market Surveillance for the Dynesys® 
Spinal System, Assessing Safety and Fusion. 
 
 
  
 
 
 
 
 
 
 
CMU2010-10S 
Version 2.0 
December 5, 2011 
 
 
Sponsor: 
Zimmer Spine, Inc. 
7375 Bush Lake Road 
Edina, MN  55439 
 
 
 

 
 
 
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TABLE OF CONTENTS 
 
PROTOCOL SUMMARY 
4 
 
 
INTRODUCTION 
 
Purpose 
7 
Objectives 
7 
Study Design 
7 
 
 
DEVICE 
 
Overview of The Dynesys® Spinal System 
8 
 
 
SUBJECT SELECTION 
 
Inclusion Criteria 
9 
Exclusion Criteria 
9 
 
 
STUDY PROCEDURE AND DATA COLLECTION 
 
Table 1. Study Schematic 
10 
Pre-Operative Visit 
11 
Operative Summary 
11 
Post-Operative – 6 Month 
11 
Post-Operative – 12/24 Month 
12 
Post-Operative - Annual Visits 
12 
Interim/Unscheduled Visits 
12 
Adverse Events 
13 
Adverse Events Advisory Group 
14 
Explant Analysis 
15 
Patient Withdrawal 
15 
Data Collection 
16 
 
 
STATISTICAL ANALYSIS 
 
Analysis Population 
17 
Primary Analysis:  Fusion Status 
19 
Primary Analysis:  Safety Endpoints & Evaluation 
19 
Analysis of Additional Endpoints 
20 
Baseline & Operative Analysis 
21 
Missing Data 
21 
Study Hypothesis and Sample Size Determination using a Literature Control 
21 
 
 
TIMELINE 
 
Clinical Trial Agreement 
22 
Institutional Approvals 
23 
Project Execution 
23 
Project Deliverables 
23 
Monitor Schedule 
23 
Record Retention 
23 
Final Reports 
23 
Termination of Study 
23 
 
 
APPENDIX A:  EXPLANT ANALYSIS PROTOCOL 
 
APPENDIX B:  IMAGING PROTOCOL 
 

 
 
 
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APPENDIX C:  INSTRUCTIONS FOR USE 
 
APPENDIX D:  SURGICAL TECHNIQUE 
 
APPENDIX E:  INFORMED CONSENT 
 
APPENDIX F:  CASE REPORT FORMS 
 

 
 
 
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PROTOCOL SUMMARY 
 
Title 
Post Market Surveillance for the Dynesys® Spinal System, Assessing 
Safety and Fusion. 
Device 
The Dynesys® Spinal System 
Study Purpose 
To assess the safety profile and fusion rates following posterior lateral 
fusion with the Dynesys ® Spinal System as an adjunct to fusion 
compared to a literature control.   
Study Design 
This is a prospective, non-randomized study involving up to 168 subjects 
at up to 12 investigative centers.  Each subject will be an appropriate 
candidate for an instrumented, pedicle screw implantation and will meet 
the inclusion and exclusion criteria defined in Section III.  Patients will 
receive either (1) Dynesys/Dynesys Top Loading with autograft at the 
instrumented levels, as an adjunct to fusion, or (2) Zimmer DTO Implant 
with autograft at the instrumented levels, as an adjunct to fusion and will 
be compared to a literature control.   
 
Data will be collected pre-operatively, operatively and post-operatively at 
six, twelve and twenty-four months. Patients will be followed annually 
thereafter until the last patient has completed follow-up. This study will be 
conducted in compliance with the protocol, GCP and applicable 
regulatory requirements.   
Enrollment Size 
Up to 168 subjects at up to 12 investigative centers 
Patient Population Patients who are candidates for a PLF procedure and meet the 
inclusion/exclusion criteria are eligible for enrollment. 
Endpoints 
Determine the fusion rates at every treated level. 
 
For adverse events at every treated level: 
 
Determine the incidence rates. 
 
Determine the severities. 
 
Determine the time course. 
For subsequent surgical procedures at every treated level: 
 
Determine the types of surgical procedures that are required. 
 
Determine the incidence rates. 
 
Determine the time course. 
Based on explanted, retrieved devices: 
 
Determine the failure modes. 
 
Determine the causes of failure. 

 
 
 
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Inclusion Criteria 
 
1. 
Patients must be skeletally mature between the ages of 20-80 
2. 
Candidate for a posterior lateral fusion between T1-S1 with 
autograft 
3. 
Degenerative spondylolisthesis with evidence of neurologic 
impairment, or  failed previous fusion (pseudarthrosis) 
4. 
Symptoms of leg and/or back pain 
5. 
Non-responsive to conservative/non-surgical treatment for at least 
three (3) months 
6. 
Must be willing and able to comply with study requirements; 
including complete necessary study paperwork and return for 
required follow-up visits. 
 
Exclusion Criteria 
1. 
Active systemic or local infection 
2. 
Obesity  
3. 
Use of interbody device 
4. 
Pregnancy  
5. 
Mental illness 
6. 
Incarceration 
7. 
Alcohol or drug abuse 
8. 
Severe osteoporosis or osteopenia 
9. 
Use in the cervical spine 
10. 
Sensitivities/allergy to metals, polymers, polyethylene, 
polycarbonate urethane and polyethylene terephthalate 
11. 
Soft tissue deficit not allowing sound closure 
12. 
Any medical or physical condition that would preclude the 
potential benefit of spinal implant surgery 
13. 
Congenital abnormalities, tumors or other conditions that would 
prevent secure component fixation that has the potential to 
decrease the useful life of the device 
14. 
Active malignancy or other significant medical comorbidities 
15. 
Any medical or mental condition which would put the patient at 
high risk due to the severity of surgery 
16. 
Inadequate pedicles of the thoracic, lumbar and sacral vertebrae 
17. 
Patient unwilling or unable to follow postoperative instructions 
Pre-Op Visit 
(  4 weeks) 
 
 
Informed Consent 
 
Patient Entrance Checklist 
 
Patient History 
 
Patient Assessment 
 
Oswestry Disability Index (ODI) 
 
Clinician Evaluation 
 
Dexa Scan:  (females, over age 50) 
 
Radiographs 

 
 
 
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Radiographic Assessment 
 
Protocol Deviation (as needed) 
 
Patient Discontinuation (as needed) 
Operative 
Summary 
 
Operative/Discharge Evaluation 
 
Adverse Event (as needed) 
 
Protocol Deviation (as needed) 
 
Patient Discontinuation (as needed) 
6 Month  
Post-Op Visit 
(  4 weeks) 
 
 
Surgeon Assessment 
 
Oswestry Disability Index (ODI)  
 
Clinician Evaluation 
 
Patient Assessment 
 
Radiographs 
 
Radiographic Assessment 
 
Protocol Deviation (as needed) 
 
Adverse Events (as  needed) 
 
Patient Discontinuation/Termination (as needed) 
12 Month  
Post-Op Visit 
(  8 weeks) 
 
Patient Assessment 
 
Oswestry Disability Index (ODI) 
 
Clinician Evaluation 
 
Radiographs 
 
Radiographic Assessment  
 
Adverse Event (as needed) 
 
Protocol Deviation (as needed) 
 
Patient Discontinuation (as needed) 
24 Month  
Post-Op Visit 
(  8 weeks) 
 
Patient Assessment 
 
Oswestry Disability Index (ODI) 
 
Clinician Evaluation 
 
Radiographs 
 
Radiographic Assessment  
 
Adverse Event (as needed) 
 
Protocol Deviation (as needed) 
 
Patient Discontinuation (as needed) 
Annual  
Post-Op Visit 
(  8 weeks) 
 
Patient Assessment 
 
Oswestry Disability Index (ODI) 
 
Clinician Evaluation 
 
Radiographs 
 
Radiographic Assessment  
 
Adverse Event (as needed) 
 
Protocol Deviation (as needed) 
 
Patient Discontinuation (as needed) 

 
 
 
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Interim / 
Unscheduled  
Visit 
 
 
Adverse Event 
Study Principle 
Investigator 
 
 
I.  
INTRODUCTION 
 
A. Purpose 
To assess the safety profile and fusion rates following posterior lateral fusion with the Dynesys ® 
Spinal System as an adjunct to fusion compared to a literature control.   
 
B. Objectives 
Determine the fusion rates at every treated level. 
 
For adverse events at every treated level: 
 
Determine the incidence rates. 
 
Determine the severities. 
 
Determine the time course. 
For subsequent surgical procedures at every treated level: 
 
Determine the types of surgical procedures that are required. 
 
Determine the incidence rates. 
 
Determine the time course. 
Based on explanted, retrieved devices: 
 
Determine the failure modes. 
 
Determine the causes of failure. 
 
C. Study Design 
This is a prospective, non-randomized study involving up to 168 subjects at up to 12 investigative 
centers.  Each subject will be an appropriate candidate for an instrumented, pedicle screw 
implantation and will meet the inclusion and exclusion criteria defined in Section III.  Patients will 
receive either (1) Dynesys/Dynesys Top Loading with autograft at the instrumented levels, as an 
adjunct to fusion, or (2) Zimmer DTO Implant with autograft at the instrumented levels, as an 
adjunct to fusion and will be compared to a literature control.   
 
Data will be collected pre-operatively, operatively and post-operatively at six, twelve and twenty-four 
months. Patients will be followed annually thereafter until the last patient has completed follow-up. 
This study will be conducted in compliance with the protocol, GCP and applicable regulatory 
requirements.   
 

 
 
 
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Clinical investigators for this study will include individuals who meet all study requirements as 
indicated in the Clinical Trial Agreement and outlined in this protocol.  Selection criteria for 
participation include: 
 
Good standing in his/her specialty 
 
Adequate time, motivation, facilities, and availability of dedicated and qualified staff for 
proper conduct of the trial 
 
Experienced in performing instrumented posterolateral fusion (PLF) procedures using 
pedicle screw fixation systems and/or Dynesys 
 
Agrees to comply with all requirements of the clinical protocol 
 
Agrees to follow the clinical protocol in accordance with all regulatory agency and 
Institutional Review Board (IRB) requests and requirements 
 
Agrees to comply with the responsibilities of a clinical investigator 
 
Adequate subject population and the potential to meet study requirements to enroll a 
minimum of two subjects per month 
 
Willingness to establish and/or continue a working relationship with Zimmer Spine, Inc 
 
Agrees to periodic center monitoring/auditing by sponsor clinical monitors and to 
inspection by regulatory authority representatives 
 
Agrees to provide sufficient and accurate financial disclosure 
 
Agrees to participate in investigator meetings 
 
II. 
DEVICE 
 
A. Overview of the Dynesys® Spinal System 
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal 
System is intended to provide immobilization and stabilization of spinal segments as an adjunct to 
fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, 
lumbar, and sacral spine; degenerative spondylolisthesis with objective evidence of neurological 
impairment, and failed previous fusion (pseudarthrosis).   
 
In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated 
for use in patients: 
 
Who are receiving fusions with autogenous graft only; 
 
Who are having the device fixed or attached to the lumbar or sacral spine; 
 
Who are having the device removed after the development of a solid fusion mass. 
 
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous 
levels, they must be used with the Zimmer DTO Implant, rod-cord combination implant, and the U & 
I Corporation OPTIMA ZS Transition Screw.  The indications for use for each level is as specified 
for each system. 
 
Dynesys is comprised of a variety of pedicle screw sizes, tensioning cords and longitudinal spacers 
that are uniquely fitted for each individual case. 
 
 
 

 
 
 
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III. 
SUBJECT SELECTION 
 
 
Patients participating in this study will be recruited from each investigator’s standard patient population.  
All patients who meet the inclusion/exclusion criteria will be consecutively enrolled.     
 
A. Inclusion Criteria 
Patients must meet all of the following criteria to be enrolled into the study: 
1. 
Patients must be skeletally mature between the ages of 20-80 
2. 
Candidate for a posterior lateral fusion between T1-S1 with autograft 
3. 
Degenerative spondylolisthesis with evidence of neurologic impairment, or failed 
previous fusion (pseudarthrosis) 
4. 
Symptoms of leg and/or back pain 
5. 
Non-responsive to conservative/non-surgical treatment for at least three (3) months 
6. 
Must be willing and able to comply with study requirements; including complete 
necessary study paperwork and return for required follow-up visits. 
 
B. Exclusion Criteria 
Patients who meet any of the following criteria should not be enrolled into the study: 
1. 
Active systemic or local infection 
2. 
Obesity  
3. 
Use of interbody device 
4. 
Pregnancy  
5. 
Mental illness 
6. 
Incarceration 
7. 
Alcohol or drug abuse 
8. 
Severe osteoporosis or osteopenia 
9. 
Use in the cervical spine 
10. 
Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and 
polyethylene terephthalate 
11. 
Soft tissue deficit not allowing sound closure 
12. 
Any medical or physical condition that would preclude the potential benefit of spinal 
implant surgery 
13. 
Congenital abnormalities, tumors or other conditions that would prevent secure 
component fixation that has the potential to decrease the useful life of the device 
14. 
Active malignancy or other significant medical comorbidities 
15. 
Any medical or mental condition which would put the patient at high risk due to the 
severity of surgery 
16. 
Inadequate pedicles of the thoracic, lumbar and sacral vertebrae 
17. 
Patient unwilling or unable to follow postoperative instructions 
 
 

 
 
 
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IV. 
STUDY PROCEDURES AND DATA COLLECTION 
 
Table 1:  Study Schematics 
 
Pre-Op 
Surgery 
6M 
12M 
24M 
Annual 
Interim / Unscheduled 
Visits 
 
-4 weeks 
 
±4 weeks 
±8 weeks 
±8 weeks  
±8 weeks 
 
Informed Consent 
X 
 
 
 
 
 
 
Patient Entrance Checklist 
X 
 
 
 
 
 
 
Patient History 
X 
 
 
 
 
 
 
Operative / Discharge Evaluation 
 
X 
 
 
 
 
 
Patient Assessment 
X 
 
X 
X 
X 
X 
 
Oswestry Disability Index (ODI) 
X 
 
X 
X 
X 
X 
 
Clinician Evaluation 
X 
 
X 
X 
X 
X 
 
Dexa Scan  
(females, 50+) 
X 
 
 
 
 
 
 
Radiographs 
(AP, NL, Flexion, Extension) 
X 
 
X 
X 
X 
X 
 
Radiographic Assessment 
X 
 
X 
X 
X 
X 
 
Adverse Event 
as needed 
X 
Explanted Device Form 
as needed 
Protocol Deviation 
as needed 
Patient Discontinuation 
as needed 

 
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A. Pre-Operative Visit (- 4 weeks) 
Patients who meet the pre-operative criteria will be enrolled in the study by signing a Zimmer Spine, 
Inc., IRB approved informed consent form prior to participating in any study activities. 
 
The following procedures and assessments will be performed prior to surgery and the results will be 
recorded on the patient case report forms (CRF): 
 
Informed Consent:  must be signed prior to any study specific procedures 
 
Patient Entrance Checklist:  gender, date of birth, height, weight, inclusion and exclusion 
criteria for study involvement 
 
Patient History:   worker’s compensation injury, primary indication, diagnostic tests, 
surgical spine history, conservative treatments and concomitant pathologies 
 
Patient Assessment: pain level  
 
Oswestry Disability Index (ODI):  functional assessment 
 
Clinician Evaluation: neurological assessment (sensory and motor testing, reflex testing 
and straight leg raising), medication usage, employment status and tobacco use.  
 
Dexa Scan:  complete if the subject is a female, over age 50 and has not or does not 
have the scan results readily available 
 
Radiographs:  A/P, N/L, flexion, extension 
 
Radiographic Assessment:  Establish baseline assessment.  
 
Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
B. Operative Summary 
The following procedures and assessments will be performed at surgery.   
 
Operative/Discharge Evaluation:  dates of admission, surgery and discharge, operative 
level, estimated blood loss, duration of surgery, discharge medications, device implant 
specifics, reason for device choice, autograft harvest and placement and neurological 
assessment 
 
Adverse Event (as needed):  record events, device relationship, date of complication, 
severity, outcome and treatment details 
 
Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
C. Post-Operative – 6 month (+/- 4 weeks) 
The following procedures and assessments will be performed following surgery. 
 
Patient Assessment: pain level and satisfaction 
 
Oswestry Disability Index (ODI):  functional assessment 
 
Clinician Evaluation: neurological assessment (sensory and motor testing, reflex testing 
and straight leg raising), medication usage, employment status, tobacco use and 
surgical results 
 
Radiographs:  A/P, N/L, flexion, extension 
 
Radiographic Assessment:  overall and unilateral fusion success (translation motion 
<3mm, angulation motion <5° and bridging bone) will be assessed by site radiologist and 
an independent reviewer  
 
Adverse Event (as needed):  record events, device relationship, date of complication, 
severity, outcome and treatment details 

 
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Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
D. Post-Operative – 12, 24 month (+/- 8 weeks) 
The following procedures and assessments will be performed following surgery. 
 
Patient Assessment: pain level and satisfaction  
 
Oswestry Disability Index (ODI):  functional assessment 
 
Clinician Evaluation: neurological assessment (sensory and motor testing, reflex testing 
and straight leg raising), medication usage, employment status, tobacco use and 
surgical results 
 
Radiographs:  A/P, N/L, flexion, extension 
 
Radiographic Assessment:  overall and unilateral fusion success (translation motion 
<3mm, angulation motion <5° and bridging bone) will be assessed by site radiologist and  
an independent reviewer  
 
Adverse Event (as needed):  record events, device relationship, date of complication, 
severity, outcome and treatment details 
 
Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
E. Post-Operative – Annual Visits after 24 month until all patients have completed the study (+/- 
8 weeks) 
The following procedures and assessments will be performed following surgery. 
 
Patient Assessment: pain level and satisfaction  
 
Oswestry Disability Index (ODI):  functional assessment 
 
Clinician Evaluation: neurological assessment (sensory and motor testing, reflex testing 
and straight leg raising), medication usage, employment status, tobacco use and 
surgical results 
 
Radiographs:  A/P, N/L, flexion, extension 
 
Radiographic Assessment:  overall and unilateral fusion success (translation motion 
<3mm, angulation motion <5° and bridging bone) will be assessed by site radiologist and  
an independent reviewer  
 
Adverse Event:  record events, device relationship, date of complication, severity, 
outcome and treatment details 
 
Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
F. Interim or Unscheduled Visits 
 
Adverse Event:  record events, device relationship, date of complication, severity, 
outcome and treatment details 
 
Explanted Device Form (as needed): date and reason for explant 
 
Protocol Deviation (as needed):  deviation and reason 
 
Patient Discontinuation (as needed):  reason for discontinuation and date  
 
 
 
 

 
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G. Adverse Events (AE) 
An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the 
use of an investigational product, whether or not related to the investigational product, taking into 
consideration the patient history, surgical history, histological analysis as well as explants 
evaluation.  Events may be complications, observations (including radiographic), change in patient 
condition or related/unrelated death.  A change indicating worsening as reported on an assessment 
is an adverse event. 
 
A serious adverse event (SAE) is any event that is fatal, life-threatening, disabling, or which results 
in hospitalization. 
 
A unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health or 
safety, or any life-threatening problem or death caused by, or associated with, a device if that effect, 
problem or death was not previously identified in nature, severity or degree of incidence, or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
 
The investigator will complete the Adverse Events case report form to capture: 
 
Date and time of onset of the event 
 
Type of complication 
 
Severity 
o 
Mild:  The AE is noticeable to the subject, but does not interfere with routine 
activity.  The AE typically does not require symptomatic therapy, rest or device 
removal. 
o 
Moderate:  The AE interferes with routine activity but responds well to 
symptomatic therapy or rest.  The AE does not require device removal. 
o 
Severe: The AE significantly limits the subject’s ability to perform routine 
activities despite symptomatic therapy.  The AE requires medical or surgical 
treatment or results in hospitalization.  In addition, the AE may require removal of 
the study device.   
 
 
Relationship to the device 
o 
Not related: An AE for which sufficient information exists to indicate that there is 
no causal connection between the event and the device/procedure.  The AE is 
due to and readily explained by the subject’s underlying disease state or is due to 
concomitant medication or therapy not related to the use of the device or the 
procedure.   
o 
Possibly related: There is a reasonable possibility that the AE may have been 
primarily caused by the device/procedure and follows a known or expected 
response pattern.  Alternative etiology is equally or more likely compared to the 
potential relationship to the use of the device/procedure.   
o 
Probably related:  There is a reasonable probability that the AE may have been 
primarily caused by the device/procedure and follows a known or expected 
response pattern. 
o 
Definitely related:  The AE has a strong casual relationship to the 
device/procedure and follows a known response pattern.  The event cannot be 

 
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reasonably explained by known characteristics of the subject’s clinical state or 
other therapies.   
 
 
Treatment includes a detailed narrative of how this adverse event was treated and the 
outcome. 
 
The outcome of the event will be defined as resolved, ongoing, study withdrawal, device revision, 
removal, reoperation, supplemental fixation and death.  Additional surgeries will include details in 
the treatment narrative. 
 
 
Revision:  a procedure that adjusts or in any way modifies or removes part of the 
original implant configuration, with or without replacement of a component.  A revision 
may also include adjusting the position of the original configuration. 
 
Removal:  a procedure where the entire original system configuration is removed 
with/without replacement.*  
 
Reoperation:  any surgical procedure at the involved level(s) that does not involve 
removal, modification or addition of any components to the system. 
 
Supplemental Fixation:  a procedure in which additional instrumentation not under 
study in the protocol is implanted at the spine level(s) under study. 
 
* Elective removals following fusion are not considered adverse events; however, they will still be reported. 
 
All adverse events observed during the course of this study, regardless of severity or relationship to 
the investigational device will be recorded on the Adverse Event case report form.  All events 
should be followed until resolved or until a chronic, stable state is achieved.   
 
All serious adverse events and unanticipated adverse device effects or events of unexpected 
severity must be reported to Zimmer Spine within 24 hours of the time the investigator learns of the 
event or effect.  Zimmer Spine will notify the reviewing IRBs within 10 days of the time of learning of 
the event.   
 
H. Adverse Events Advisory Group 
 
Independent spine surgeons (neuro or orthopedic) will be selected from a subset of 13 member (10 
US and 3 OUS) Zimmer Spine Clinical Affairs Advisory Group (CAAG), who are not study 
investigators, to determine adverse event severity and device relationship.   
 
The CAAG surgeons serve two-year terms and function to provide expert advice to the Clinical 
Affairs department with respect to protocol development, unmet clinical needs, clinical benefits of 
devices, quantification and measurement of clinical evaluations, pathology, diagnosis and indication 
and review of explant cases during clinical trials.  The surgeons have a strong core competency in 
the conduct and logistics of clinical trials.  This group allows Zimmer Spine the ability to a quickly 
and responsibly respond to any questions regarding clinical use of our devices, review of data from 
clinical trials and response to other research collaborators with respect to study conduct.  The 
members of this panel can be trained on the protocol, most importantly, with respect to the blind 
adjudication of adverse events determining severity and relatedness.  The depth of the panel allows 

 
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Zimmer Spine to easily convene three members for adjudication and receive expert assistance in 
review of any adverse events that may ultimately be “unanticipated” or “serious.” 
 
The adjudication process will occur at least annually during the study.  Reviewers will be blinded to 
the site.  Two independent surgeons will review all available appropriate data (including CRFs, AE 
forms, hospital operative reports, lab reports, films, discharge reports, etc.) and determine:   
 
whether the event is related to the device, device procedure, general surgery; or none of 
the above  
 
AE severity (mild, moderate, severe) 
 
whether the event constitutes a SAE or UADE.    
 
In instances of non-concordance between the two surgeons, a third surgeon will provide the final 
determination. The surgeons will provide their review, adjudication and reporting independent of the 
trial. 
 
All reviewing surgeons’ determinations regarding the AEs are final and supersede preliminary 
judgments made by each clinical investigator. 
 
The sponsor has the responsibility for coordinating the adjudication process.  All correspondence, 
reports, minutes and other documentation as applicable will be supplied to the FDA as part of the 
regular progress reports. 
 
The sponsor will notify regulatory authorities (FDA, IRB, etc) and the clinical study investigators of 
any SAE/UADEs in accordance with regulations. 
 
I.   Explant Analysis 
All hardware segments, complete constructs or components must be returned to Zimmer Spine for 
analysis by the site using the explant kits provided at the initiation training.  Instructions and all 
necessary materials for returning the hardware will be included in the explant kit.  Investigators and 
external Zimmer representatives will be trained on the importance and process of returning explants 
for analysis.      
 
Every attempt will be made to evaluate the explanted devices using the Analysis of Dynesys 
Explants Protocol (Appendix A).  A secondary analysis to determine the association (if any) 
between demographics, clinical data, device failure and characteristics will also be completed.   
 
J. Patient Withdrawal 
A patient is enrolled in the study by signing a Zimmer Spine, Inc., IRB approved informed consent.  
No personal health information will be collected from the patient prior to obtaining a signed informed 
consent.   
 
Patients who are determined to be ineligible prior to surgery will be considered screen failures and 
will not require additional follow-up visits.  The reason(s) for ineligibility will be documented on the 
Patient Discontinuation case report form. 
 

 
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Patients who complete the Pre-Operative visit, but do not receive treatment with the study device 
will be considered discontinued.  The Patient Discontinuation case report form will indicate 
proposed surgery not performed.   
 
Patients have a right to withdraw permission (revoke informed consent authorization).  Patients who 
withdraw consent will have no further private health information collected.  Once authorization is 
revoked, patients may no longer participate in the research activities, but standard medical care will 
not be affected. Revoking authorization only affects information obtained after the request has been 
received, but not information obtained prior to that time.  Patient withdrawal will be documented on 
the Patient Discontinuation case report form.  
 
Remuneration will be provided to all subjects who complete scheduled follow-up office assessments 
at 24 months and annual follow-up visits thereafter as required. The subjects’ financial 
compensation package will be outlined in the Informed Consent Form and approved by the 
Institutional Review Board (IRB) prior to the start of the study.   
 
Every attempt will be made to contact patients who are non-compliant or lost to follow-up.  Three 
contact attempts by certified letters will be documented.  Patients who are lost to follow-up will be 
documented on the Patient Discontinuation case report form.   
 
To compensate for a potential 20% attrition rate, additional subjects have been added to the sample 
size.  The number of enrolled and completed subjects will be closely monitored, and if needed 
patients will be added to assure the study endpoints can be achieved.   
 
K. Data Collection 
The purpose of the case report form is to reconstruct the study.  Information should always be 
documented in the source document first, and then transferred to the case report form, either paper 
or electronic.  As an exception, the Oswestry Disability Index (ODI) and Patient Assessment forms 
are considered source documents.  It is recommended that patient questionnaires be completed 
prior to the patient meeting with any clinical staff to minimize the bias in the study or in accordance 
with site specific standard operating procedures.   
 
Patient confidentiality will be protected at all times and patient identifiers will be used.  
 
Case report forms must be completed in black ink.  To correct an entry, strike a single line through 
the error and mark the correct response.  Date and initial the correction.  Do not use liquid paper or 
correction tape. 
 
Case report forms should be submitted via an electronic data capture system within 15 days of 
evaluation.  Radiographs should be sent via Fed Ex to Zimmer Spine, Clinical Affairs, 5251 W 73rd 
Street, Edina, MN  55439 within two weeks of evaluation.   
 
 
 
 
 
 

 
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V. STATISTICAL ANALYSIS 
 
A. Analysis Population 
The population for analysis will include all subjects who have completed eligibility screening, signed 
an informed consent, and have met inclusion and exclusion requirements. 
 
A poolability analysis will be done to ensure that the two Dynesys devices (Dynesys/Dynesys Top 
Loading with autograft at the instrumented levels and Zimmer DTO Implant with autograft at the 
instrumented levels) have similar outcomes.  The summary statistics resulting from the primary 
safety and fusion endpoints, for each subgroup, will be explored to assess possible differences in 
results based on the subgroup.  Additionally, poolability will be assessed by comparing the sub 
group population characteristics for key baseline, demographic and clinical characteristics as well 
as for primary diagnoses.  If there are no differences in this comparison, the subgroups will be 
pooled for the purpose of analysis. 
 
Similarly, a poolability analysis will be done to ensure that there are no differences in outcomes 
between the different level procedures (1-level, 2-level, 3-level).  The summary statistics resulting 
from the primary safety and fusion endpoints, for each subgroup, will be explored to assess 
possible differences in results between the subgroups.  Additionally, poolability will be assessed by 
comparing the sub group population characteristics for key baseline, demographic and clinical  
 
characteristics as well as for primary diagnoses.  If there are no differences in these comparisons, 
the subgroups will be pooled for the purpose of analysis. 
 
A meta-analysis was done using the same methodology as was used for the primary endpoint, 
fusion rate.  When sufficient data were available for baseline characteristics, point estimates and 
95% confidence intervals were generated for use to assess comparability of baseline data in the 
historical literature to the experimental data.  The data were extracted from the same literature that 
was used to obtain an estimate for the primary endpoint of fusion rate.  The first table below 
represents the detail available for use in comparison of the treatment group to the literature control 
data for the baseline characteristics and the second table contains the point estimates of interest for 
the baseline characteristics from the literature.  Comparability will be inferred if the rates of males or 
smoking status in the experimental group are contained in the respective 95% confidence intervals 
established using the literature control rates.  Comparability for age will be inferred if the point 
estimate for mean age in the experimental group is contained in the range presented for the 
historical control.  Additionally, a frequency distribution of pre-operative diagnoses, from both the 
experimental group and what is available in the literature control group will be done to ensure 
comparability between the data from each. 
 
 

 
Page 18 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic Endpoints 
N 
Age 
Gender 
(% Male) 
Smoking 
Status (%) 
BMI 
Acharya 2008 
22 
55 
36.4% 
 
 
Chen 2005* 
74 
61.6 
20.3% 
 
 
Cheng 2009 
66 
48 
52.9% 
0.221 
 
Christensen 2002 
63 
46 
41.3% 
0.65 
 
Christensen 2002 
71 
45.5 
37.0% 
 
 
Dimar 2006 
45 
52.7 
44.4% 
0.222 
 
Fernandez-Fairen_1 2007 
41 
61.42 
35.7% 
 
 
Glassman 2008 
52 
69.9 
32.7% 
0.173 
28.1 +/-6.1 
Lee 2009 
182 
59 
33.5% 
 
 
Moller 2000 
37 
39 
43.2% 
0.57 
 
Thalgott_1 1997 
21 
55 
 
0.429 
 
Thalgott_2 1997 
21 
45 
 
0.523 
 
Wang 1998 
94 
67.03 
17.0% 
 
 
  
Point Estimates  
Demographic Endpoints 
  
  
  
  
Age 
Mean 
STD 
MIN 
MAX 
Weighted Average 
55.9706 
NA 
40.72783 
75.31652 
   
Random Effects 
Rate 
SE 
LCL 
UCL 
Gender (Male) 
35.78% 
3.14% 
28.78% 
42.77% 
Smoking Status 
39.11% 
7.13% 
21.64% 
56.57% 
  
  
BMI - not enough information 
  
  
  
  

 
Page 19 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
To assure that baseline characteristics of the history control data are similar to those found in the 
experimental data, the demographic characteristics from the study data will be reviewed to confirm 
that the characteristics of age, gender, smoking status, and preoperative diagnosis in the test data 
are similar to the data that existed for the historical control data.  The rate of males and rate of 
smokers will be checked against the 95% confidence interval found in the point estimate table.  The 
distribution of preoperative diagnoses will be tested for no difference between the historical control 
and the test group.  The average age will checked to assure that it is in the range from 41 to 75.  If 
any differences are noted, patients with extreme data will be removed until the rates and means of 
the test population do reside within the bounds determined by the meta-analysis.  If needed, more 
patients will be enrolled in the test group to assure that the sample size is sufficient for inferential 
testing. 
 
 
B. Primary Analysis: Fusion Status 
Fusion success will be defined as evidence of bridging bone and angulation of <5° and translation 
of <3mm at treated levels at 24 months.  Radiographic assessment will determine for each patient a 
fusion status, either fused or not fused.  The primary endpoint is fusion status at Month 24.  Efficacy 
will be confirmed by the achievement of fusion in the experimental group when compared to the 
rate established in a literature control.  Normand (1999) provided the direction for the meta-
analysis1.  The details of that analysis included creating population mean and variance estimates 
using a weight of the inverse of the variance.  (See pp. 335-336 for complete description of the 
algorithm)  A point estimate of 80.6% with a standard error of 2.6% was established.  The 95% 
confidence interval for this point estimate is (75.0%, 86.3%).   
 
If Month 24 fusion status cannot be determined, but fusion was determined to have occurred earlier, 
the Month 24 status will be considered fused. Otherwise, subjects without earlier fusion who are 
missing Month 24 values will be excluded from primary analysis. 
 
For the purpose of a sensitivity analyses, all subjects excluded as described above for a missing 
Month 24 fusion status will be defined as not fused.  
 
C. Primary Analysis:  Safety Endpoints and Evaluation 
Subjects will be clinically evaluated for adverse experiences and functional outcomes over the 
course of 24 months.   
 
Detailed and descriptive analyses will be provided for all adverse events, including specific 
treatment required and outcomes for all secondary surgeries at the index and adjacent levels, any 
deaths, and all potential device related adverse events.  Adverse event incidence rates, severities 
and time course will be determined.  For subsequent surgical procedures, at every treated level, the 
type of surgical procedure required the incidence rate and time course will be determined and 
reported. 
 
                                                 
1 Normand, S. T. (1999). Tutorial in biostatistics meta-analysis: Formulating, evaluating, combining, and reporting. Statist. Med. (18), 321-359. 
 

 
Page 20 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
All of the safety endpoints will be summarized descriptively at all available assessments.  
Summaries will be chosen as appropriate for the scale and distribution of the measures being 
analyzed.  For categorical variables, summaries will consist of counts and percentages to describe 
the distribution of the endpoint.  For continuous variables, descriptive summaries will consist of N, 
Mean, Median, Standard Deviation, Minimum and Maximum.  Similarly, exact incidence and rates 
of AEs and subsequent surgical procedures will be calculated for the experimental group and 
whenever possible for the control group.  
 
Assessing adverse events (AEs) using only the literature control data is not sufficient, because of 
the heterogeneity of reporting across the manuscripts.  Thus, we propose using the observed data 
from the recent Dynesys IDE clinical study (historical).  The AEs collected in this study (historical) is 
expected to have a similar profile as those in the present study (experimental).  A test for non-
inferiority will be performed using both incidence and rates, for each AE category, in both the 
historical control and experimental group.  Non-inferiority will be inferred if the lower limit of the 95% 
confidence interval around the treatment difference between the 2 groups is greater than δ = -10%, 
using the hypotheses below where pe is the incidence or rate in the experimental group and pd is 
the incidence or rate in the historical study group.  
 
H0: pe – pd <  - 0.10 
H1: pe – pd >  - 0.10 
 
In addition, for each category of AE in the experimental group, a non-inferiority analysis will be 
performed assessing how the incidence and rates in the experimental group compare to the AEs as 
described in each of the contributing articles that were used for the meta-analysis. The incident rate 
that occurs in the experimental data will be computed with a 95% confidence interval.  Any AEs that 
occurred in any of the literature control studies will be compared to those ranges to ensure that the 
incidence or rate found in the experimental group does not exceed the incidence or rate in the 
literature data.  Non-inferiority will be inferred if the assessment of AEs under both analyses meets 
the specified criteria for non-inferiority. 
 
Any explanted devices will be retrieved and evaluated for determination of failure modes and 
causes.  Any correlation between the subject’s demographic data and device failure will be 
determined. 
 
 
D. Analysis of Additional Endpoints 
Fusion status, at all time intervals other than the 24 month, as well as any other collected endpoints 
will be analyzed to assess the overall safety of the patient population in this investigation.   
 
The following post-operative outcomes will be summarized: 
 
Neurologic Assessment 
 
Medication Usage 
 
Employment Status 
 
Pain Assessment 
 
Satisfaction Assessment 
 
Oswestry Disability Index (ODI)  
 

 
Page 21 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
These and any additional endpoints will be summarized descriptively at all available assessments, 
both as originally collected and with a change from baseline calculation including the number of 
subjects who improved, the number who deteriorated and the number who stayed the same from 
baseline.  Summaries will be chosen as appropriate for the scale and distribution of the measures 
being analyzed.  For categorical variables, summaries will consist of counts and percentages to 
describe the distribution of the endpoint.  For continuous variables, descriptive summaries will 
consist of N, Mean, Median, Standard Deviation, Minimum, and Maximum.   
 
To compare the AEs that are collected in the experimental group to the literature data, in all interim 
clinical summaries, as well as the final clinical summary, a tabular comparison of incidence 
observed for all literature reported AEs or secondary surgeries to those prospectively captured will 
be presented in a format similar to the table below: 
 
Adverse Event 
Article 
#1 
Article 
#2 
etc 
522i 
Result 
Screw Fracture 
 
 
 
 
Pseudarthrosis 
 
 
 
 
Secondary Surgery 
 
 
 
 
Revision 
 
 
 
 
Removal 
and 
Refusion 
 
 
 
 
 
E. Baseline and Operative Analysis 
Baseline summaries will be chosen to be appropriate for the scale and distribution of the measures 
being analyzed.  Statistical methods will be the same as described above for the non primary 
endpoint analyses. 
 
F. Missing data 
 
Except for the primary analysis, if a value, at any assessment is not available for analysis, it will be 
 
excluded from summaries. 
 
G. Study Hypothesis and Sample Size Determination using a Literature Control 
 
Study Hypothesis 
 
The hypothesis is Dynesys fusion rate is non-inferior to the historical literature sample data 
estimated fusion rate of 80.6%.  This hypothesis will be assessed by testing that the difference 
between the experimental rate (pe) and the historical control rate (pc) is not worse than 10%.  The 
non-inferiority test will be inferred if the lower limit of the 95% confidence interval around the 
treatment difference between 2 groups is greater than δ = -10%. 
 
H0: pe - pc <  - 0.10 
H1: pe - pc >  - 0.10 
 
Sample Size 
Sample size for the Dynesys Post-Market Surveillance Study was estimated using SAS, Proc 
Power with a testing level alpha (Type I) error level of 0.05, 80 percent statistical power, a 
meaningful difference of 10%, and a success rate for lumbar fusion from the literature historical 

 
Page 22 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
control group of 80.6% (0.806). For this set of criteria, the sample size was 134, without adjustment 
for attrition.  With a 20% attrition sample added, this would result in a sample size of 168. 
   
Sample size estimates are presented in Table 2. 
 
Table 2:  Proposed Sample Sizes  
Primary 
Endpoint 
Difference  
Predicted 
Success 
 
Type I Error 
Power 
N Patients 
Radiographic 
Success (Fusion) 
10% 
80.6% 
0.05 
80% 
168 
 
 
VI. 
TIMELINE 
 
A. Clinical Trial Agreement  
No portion of this protocol will be implemented until both copies of the Clinical Trial Agreement 
havebeen completed by both parties. 
 
 
Table 3:  Study Timeline 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Timeline 
Sponsor Expectation 
Expected date of Study Initiation 
March 2012 
Expected date of first IRB Approval(s) 
January 2012 
Expected monthly number of sites 
obtaining IRB approval 
1 
Expected subject enrollment initiation 
March 2012 
Expected average number of subjects to 
be enrolled/month 
7 
Expected Date of Subject Enrollment 
Completion 
March 2014 
Expected date of Subject follow-up 
Completion  
March 2016 
Reports 
Interim Postmarket Surveillance Study 
Report 
Every 6 months through 2 years, 
annually thereafter 
Expected date for the Final Postmarket 
Surveillance Study Report 
June 2016 

 
Page 23 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
B. Institutional Approvals 
No portion of this protocol will be implemented until approval is granted by the institutional review 
board.  No personal health information or other data will be transmitted to Zimmer Spine without 
consent from the patient.  
 
C. Project Execution 
This project will begin at the time of contract agreement execution.  IRB approval will be obtained 
within 2 months.  Enrollment will start following IRB approval and site initiation.  The first patient will 
be enrolled within 2 months after IRB approval.  Enrollment will take place for 24 months.  Follow-
up of all patients will be complete within 26 months (24 months +/- 2 month visit window) following 
the last surgery.   
 
D. Project Deliverables 
The site must provide Zimmer Spine with a copy of the report submitted to the IRB for annual 
renewal and the approval status within two weeks of receipt.  The report must include the number of 
patients enrolled and the treated levels.   
 
E. Monitor Schedule 
This study will be monitored a minimum of one time every 12 months by Zimmer Spine Clinical 
Affairs personnel per the Zimmer Spine monitoring procedure. The purpose of these visits is to 
review the patient charts, to verify the data submission process, and to clarify any discrepancies.  
With increased enrollment or center challenges, monitoring may occur more than once a year. 
 
F. Record Retention 
 
The investigator will maintain the records of the study including all correspondence, the study 
protocol with any/all amendments, all correspondence with and approval from the IRB, the budget 
agreement, the research agreement, individual patient records, and signed informed consent forms.  
Patient files and other source data must be kept for a period of not less than 2 years after the date 
on which this investigation is terminated or completed.   
 
G. Final Reports 
A final report produced by the lead principal investigator will be written in a format acceptable for a 
peer reviewed journal. 
 
H. Termination of Study 
The study may be terminated per the terms of the Clinical Trial Agreement at any time. 
 

 
Page 24 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix A:   
EXPLANT ANALYSIS PROTOCOL 

 
Page 25 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix B:  
IMAGING PROTOCOL 

 
Page 26 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix C:  
INSTRUCTIONS FOR USE 
 
The Instructions for Use as provided in the January 21, 2010, response to FDA will be used and are not 
repeated here. 

 
Page 27 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix D:  
SURGICAL TECHNIQUE 
 
The Surgical Techniques as provided in the January 21, 2010, response to FDA will be used and are not 
repeated here. 

 
Page 28 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix E:  
INFORMED CONSENT 

 
Page 29 of 29 
CMU 2010-10S 
V2.0 December 5, 2011 
 
 
Appendix F:  
CASE REPORT FORMS 
 

Zimmer 
Research Protocol 
ANALYSIS OF RETRIEVED DYNESYS 
EXPLANTS 
Page 1 of 9 
September 201 1 
Abstract: 
This document describes the various methods for retrieval analysis of 
explanted DYNESYS 1 DTO spinal implant systems, including PCU 
spacers, PET cords, titanium alloyed pedicle and set screws, and DTO 
implants, which are manufactured at Zimmer GmbH, Winterthur, 
Switzerland. 
Personnel: 
Petra Köttig, Retrieval analysis 
Location: 
Zimmer GmbH, Winterthur, Switzerland 
~ u t k r  
- Petra Köttig 
Werner Schneider 
Markus Windler 
Sr. Engineer I1 Retrievals Research 
Principal Engineer Polymers Research 
Materials Research Director 
C 
Jochen Reinmuth 
Marco Zimmermann 
Elsa Linke 
rincipal Engineer Spine Development 
Regulatory Affairs Manager 
Sr. Regulatory Affairs Specialist 
John Dawson 
Global Research Director 
Keywords: 
Petrieval, DYNESYS, DTO implant, FTIR analysis, GPC analysis 
C O N F I D E N T I A L  
AAU Q.01.1072e 
This document contains proprietary and confidential information owned by Zimmer, 
distributed without taking appropriate action to protect its contents according to 
Protocol Number: ZRP-Wl-1856-10-Rev 
1 

Zimmer 
Research Protocol 
ANALYSIS OF RETRIEVED DYNESYS 
EXPLANTS 
Page 1 of 9 
September 201 1 
Abstract: 
This document describes the various methods for retrieval analysis of 
explanted DYNESYS 1 DTO spinal implant systems, including PCU 
spacers, PET cords, titanium alloyed pedicle and Set screws, and DTO 
implants, which are inanufactured at Zimmer GmbH, Wintei.thus, 
Switzerland. 
Personnel: 
Petra Köttig, Retrieijal analysis 
Location: 
Zil?iiller GmbH, Wjnferfhzlr, Sti)itzerland 
Author - Petra Kattig 
Werner Schneider 
Markits Windler 
Sr. Engineer I1 Retrievals Research 
Principal Engineer Polynlers Researcli 
Materials Research Director 
Jochen Reinmiith 
Marco Zimniemann 
Principal Engineer Spine Develop~nent 
Regulatory Affairs Manager 
Elsa Linke 
Sr. Regulatory Affairs Specialist 
John Dawson 
Global Research Director 
Kewvords: 
Retrieval, DYNESYS, DTO implant, FTIR analysis, GPC analysis 
C O N F I D E N T I A L  
This document contains proprietary and confidential information owned by Zimmer, Inc. and should not be 
distrlbuted without taking appropriate actlon to protect its contents accordlng to Zimmer procedures. 
AAU Q.01.1072e 
Protocol Number: ZRP-WI-I 856-1 0-Rev I 

ZRP_WI_1856_10_Rev 1 
Page 2 of 9 
1 INTRODUCTION 
The Dynesys® dynamic stabilization system is a pedicle screw system that has been in clinical use 
for about 16 years. It consists of titanium alloy pedicle screws, coated and un-coated with 
hydroxyapatite, set screws, polycarbonate urethane (PCU) spacers and polyethylene terephthalate 
(PET) cord. The Zimmer DTO Implant, consisting of a titanium alloy rod and PET cord, was 
introduced in 2007 to allow connection of the Dynesys dynamic system to the Optima rigid pedicle 
screw system.  
The Dynesys components consist of the following materials: 
• Pedicle screw made of Titanium alloy (PROTASUL-100) according to ISO 5832-11  
• Set screw made of Titanium alloy (PROTASUL-100) according to ISO 5832-11 
• Spacers made of Sulene® PCU (Polycarbonate-urethane). 
• Cord made of Sulene® PET (Polyethylene-terephthalate) 
• DTO Implant made of of Titanium alloy (PROTASUL-100) according to ISO 5832-11 and 
Sulene® PET (Polyethylene-terephthalate) 
One of the markets in which Dynesys is sold is the United States.  The US medical device 
regulatory body, FDA, has ordered that a post-market surveillance study be conducted on all 
Dynesys device configurations for the US cleared indication as an adjunct to fusion.  As part of 
this post market surveillance study FDA has mandated an analysis of all Dynesys explants 
received worldwide to identify possible failure modes, the clinical circumstances in which failure 
is occurring, and associated patient demographics. 
2 OBJECTIVE 
The goal of this study is to perform retrieval analysis [1-3] on all explants received at Zimmer, 
including the identification of structural failures in failed components.  Structural failures are 
classified as fractured pedicle screws, set screws or Titanium rods, rupture of PET cords, or 
fracture and cracking of PCU spacers that lead to malfunction or non-function of the components 
or the system. 
3 HANDLING of RETRIEVALS 
Revision surgery: A patient outside the US needs to give his/her written consent that he/she 
agrees that the explants will be used for investigation which might include adverse modification or 
destructive testing of the explants [8]. If the patient agrees to the investigation of his/her explants 
the rights of ownership and storage of the retrievals will be handed over to Zimmer GmbH.  
From US patients no written patient consent for explant analysis is required even if the 
investigation might include adverse modification or destructive testing. 
All removed Dynesys parts must be fully traceable back to the instrumented levels and side of 
vertebra. All retrieved implants of a received system must be sent back to Zimmer. 
Cleaning, disinfection, sterilization: Immediately after removal the explanted Dynesys parts 
must be carefully cleaned by rinsing under cold (<20ºC) tap water (no brushing). The components 
should be free of attached soft tissue after cleaning. The components must not be treated with any 
cleaning agent; an investigation may not be possible if a cleaning agent is used. It is possible to 

ZRP_WI_1856_10_Rev 1 
Page 3 of 9 
autoclave the screws. The PCU spacers, the PET cords and DTO implant must not be autoclaved; 
if they are autoclaved an investigation is not possible. 
Storage and shipment condition: All components should be dried in air with no additional heat. 
The components should be packaged individually in plastic bags and labeled with patient’s 
identifier and instrumented levels e. g. patient initials or ID, L5, right.  
General information: The following information is needed to do a full retrieval assessment at 
Zimmer GmbH: 
Patient: initials or patient ID, gender, birthday, body mass index or height and weight 
Clinical: implantation date, revision date, reason for revision, treated segments, name of surgeon, 
name and address of hospital/clinic, surgical notes, x-rays 
Product information: REF number and LOT number from the spacers and cords. This information 
is only available from the implantation of the device (patient chart stickers) and not on the device 
itself. Without this information no conclusions may be drawn about the impact of manufacturing 
on the explants. 
Note: The quality of the retrieval analysis depends on the quality of data we receive from the 
hospital and from the quality of the explanted Dynesys parts. Wrong handling of the retrieved 
components or missing information can influence the quality of the analysis; under certain 
conditions the investigation can not be performed. For retrievals coming from patients outside the 
US a written consent of the patient has to be at hand to conduct adverse modification or 
destructive testing of the explants. Without written patient consent only visual inspection can be 
performed. 
4 MATERIALS and METHODS 
4.1 Material 
All retrievals received at Zimmer. 
4.2 Methods 
4.2.1 General 
The following methods will be used for the specific investigation of the single parts of the Dynesys 
system. 
Component 
Used investigation methods 
Pedicle screw 
Visual inspection  
Low power light microscope 
Scanning Electron Microscopy (SEM) (if 
necessary and / or of interest) 
Set screw 
Visual inspection  
Low power light microscope 
SEM (if necessary and / or of interest) 

ZRP_WI_1856_10_Rev 1 
Page 4 of 9 
Spacer 
Visual inspection  
Low power light microscope 
SEM (if necessary and / or of interest) 
Attenuated Total Reflection Fourier Transform 
Infrared Spectroscopy (ATR-FTIR) 
Gel Permeation Chromatography (GPC) 
Cord 
Visual inspection  
Low power light microscope 
SEM (if necessary and / or of interest) 
ATR-FTIR 
GPC 
DTO Implant  
Visual inspection 
Low power light microscope 
SEM (if necessary and / or of interest) 
ATR-FTIR for the cord only 
GPC for the cord only 
4.2.2 Sample preparation 
Pedicle and set screws will be disinfected by the following steps:  
• soaking at room temperature in a 4% disinfective solution (Deconex 53 plus, Borer Chemie 
AG, Zuchwil Switzerland) for 30 minutes ± 5 minutes 
• rinsing with cold (<20ºC) tap water 
• soaking in industrial ethyl alcohol (96%) for one hour ± 10 minutes.  
• rinsing with cold (<20ºC) tap water 
• autoclaving at 134°C for 18 min 
 
Spacers, cords and DTO implants will be disinfected by the following steps: 
• soaking at room temperature in a 4% disinfective solution (Deconex 53 plus, Borer Chemie 
AG, Zuchwil Switzerland) for 30 minutes ± 5 minutes 
• rinsing with cold (<20ºC) tap water 
These steps will be repeated three times. 
4.2.3 Visual inspection 
Visual Inspection 
All explanted components will be visually inspected by the naked eye. Areas of interests are: 
contact areas, fractured surfaces, wear/tear, surface cracks, discoloration, deformation, or other 
interested phenomena. Photographical documentation of the components will be performed if it 
helps for clarification or documentation. 

ZRP_WI_1856_10_Rev 1 
Page 5 of 9 
Low Power Light Microscope 
This method allows documentation of areas of interest on the components up to 40X. 
SEM 
The method of the SEM allows two functions: (1) imaging of areas of interest with high 
magnification and (2) semi-quantitative analysis of elemental composition of areas of interest.  
SEM enables a profound analysis of fractures, wear, and cracks. 
(1) Imaging of surface: High-powered electron beam that produces an image with secondary 
electrons (SE) or back-scattered electrons (BSE). Polymer materials must be sputter coated before 
with a thin layer of carbon or gold. This method will be used if the magnifications of 40X provided 
by the low power light microscope is not sufficient perform a full analysis of areas of interest. 
(2) Elemental analysis: The technique is energy dispersive X-ray analysis (EDX) to identify 
elemental composition of small areas. Polymer materials must be sputter coated before with a thin 
layer of carbon or gold. 
4.2.4 ATR-FTIR Analyses of PET Cords 
Fracture, rupture and cracking of polymeric components originates at the molecular level due to the 
chemical changes that result from the chemical reactions between polymeric components and the 
environment of the human body.  ATR-FTIR Analyses will produce spectra readings that reveal the 
chemical structures of the polymer.  If there are changes in the chemical structures this may be indicative of 
changes and breakage of molecular bonds.   PET cord samples will be placed on an ATR cell, and the 
spectra will be recorded using an FTIR with a scan range of 400-4000 cm-1 and a scan resolution of 4 cm-1. 
FTIR spectra will be taken from a minimum of two different locations at the PET cord: (1) on the outer 
woven cord surface, and (2) on the center fibers of cord.  
To evaluate the differences in all the spectra and to assess the absence of residual tissue, the spectra will be 
normalized to the band of a chemically stable aromatic group (725 cm-1) and compared to the spectra of a 
non-implanted reference PET cord. Control (reference) specimens will be current-production parts.  
To evaluate the possible chemical change of the PET cord due to hydrolytic degradation, the carboxyl 
index, i.e., the absorbance ratio of the carboxylic acid (1640 cm-1) to the carbonyl group (1713 cm-1), will be 
calculated. To minimize the interference from the protein bands of residual tissues, only the spectra that 
have weak or no protein bands at 1520-1540 and 1650 cm-1 will be recorded.  
4.2.5 ATR-FTIR Analyses of PCU Spacers 
Fracture, rupture and cracking of polymeric components originates at the molecular level due to the 
chemical changes that result from the chemical reactions between polymeric components and the 
environment of the human body.  ATR-FTIR Analyses will produce spectra readings that reveal the 
chemical structures of the polymer.  If there are changes in the chemical structures this may be indicative of 
changes and breakage of molecular bonds.   PCU spacer samples will be placed on an ATR cell, and the 
spectra will be recorded using a FTIR with a scan range of 400-4000 cm-1 and a scan resolution of 4 cm-1. 
The ATR-FTIR spectra of PCU spacers will be specifically collected from at least three sample locations: 
(1) on the spacer surface, (2) 100 µm below the surface and (3) in the bulk of spacer. Because the surface 
chemistry of polyurethanes may vary in the air environment, spectra of the bulk spacer samples will be 
recorded immediately after cutting them.  
All spectra will be normalized to the chemically stable aromatic group (510 cm-1). Subsequently, the spectra 
will be compared to a representative non-implanted reference PCU spacer. Control (reference) specimens 
will be current-production parts.  

ZRP_WI_1856_10_Rev 1 
Page 6 of 9 
The percentage differences in peak height of the retrieval samples to the reference PCU sample will be 
quantified using the following peaks: (1) NH (~3340   cm-1) and (2) hydrogen-bonded C=O (~1701 cm-1) of 
urethane hard segment, (3) free C=O (~1740 cm-1) and (4) C-O-C (~1248 cm-1) of carbonate soft segment, 
and (5) the broad band at 3200-3500 cm-1 (measured at ~3280 cm-1) corresponding to the increase in NH 
and OH of degraded urethane and carbonate or to absorbed biofluid.  
4.2.6 GPC Analyses of PET Cords 
Gel Permeation Chromatography will produce spectra identifying the molecular weight and distribution of 
the PET polymer.  Molecular changes may be indicative of bond breakages.  The PET cord samples (on the 
outer woven cord surface, and on the center fibers of cord) will be completely dissolved in 
hexafluoroisopropanol (3 g/L) with 0.05M potassium-trifluoroacetate. The chromatography is done in a 
PSS-PFG 7 μm column or comparable. Poly(methyl-methacrylate) standards will be used for calibration.  
The weight average molecular weight (Mw), number average molecular weight (Mn), and the polydispersity 
indices (PDI, the ratio of Mw to Mn) will be calculated. The results will be compared to a representative 
non-implanted reference PET cord. Control (reference) specimens will be current-production parts. 
4.2.7 GPC Analyses of PCU Spacers 
Gel Permeation Chromatography will produce spectra identifying the molecular weight and distribution of 
the PCU Spacer polymer.  Molecular changes may be indicative of bond breakages.  The PCU samples (on 
the spacer surface of 0-100 µm below the surface, and in the bulk of spacer) are dissolved in 
dimethylacetamide (3 g/L) with 0.1% of LiBr at 80°C. The chromatography is done in a PSS-GRAM 10 μm 
column or comparable. Polystyrene standards will be used for calibration.  
The weight average molecular weight (Mw), number average molecular weight (Mn), and the polydispersity 
indices (PDI, the ratio of Mw to Mn) will be calculated. The results will be compared to a representative 
non-implanted reference PCU spacer. Control (reference) specimens will be current-production parts. 
4.3 Test method and sample size rationale 
Component 
Used investigation methods 
Sample selection including rationale 
Pedicle screw Visual inspection  
All 
Low power light microscope 
All 
SEM (if necessary and / or of interest) 
Fracture surfaces 
Set screw 
Visual inspection  
All 
Low power light microscope 
All 
SEM (if necessary and / or of interest) 
Special phenomena (e.g., cracks) 
Spacer 
Visual inspection  
All (discoloration, deformation, surface) 
Low power light microscope 
All 
SEM (if necessary and / or of interest) 
Contact areas, worn areas, surface cracks 
ATR-FTIR 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4-6]. 
One contact area, one non-contact area 
and if available a worn area of one 

ZRP_WI_1856_10_Rev 1 
Page 7 of 9 
representative sample. 
It is assumed that all spacers of a system 
are subjected to the same body 
environment (same body fluid, body 
temperature etc.) resulting in the same 
material behavior for all spacers. 
GPC 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4-6]. 
One non-contact area of one 
representative sample. 
It is assumed that all spacers of a system 
are subjected to the same body 
environment resulting in the same bio-
stability behavior for all spacers. 
Cord 
Visual inspection  
All (surface, worn areas) 
Low power light microscope 
All 
SEM (if necessary and / or of interest) 
Contact areas, worn areas, cord ruptures 
ATR-FTIR 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4, 5, 7]. 
One contact area, one non-contact area 
and if available a worn area of one 
representative sample. 
It is assumed that all cords of a system 
are subjected to the same body 
environment resulting in the same 
material behavior for all cords. 
GPC 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4, 5, 7]. 
One non-contact area of one 
representative sample. 
It is assumed that all cords of a system 
are subjected to the same body 
environment resulting in the same bio-
stability behavior for all cords. 
DTO implant 
Visual inspection 
All (contact areas, worn areas, fracture 
surfaces) 

ZRP_WI_1856_10_Rev 1 
Page 8 of 9 
Low power light microscope 
All 
SEM (if necessary and / or of interest) 
Contact areas, worn areas, cord ruptures 
or rod fractures 
ATR-FTIR for the cord only 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4, 5, 7]. 
One contact area, one non-contact area 
and if available a worn area of one 
representative sample. 
It is assumed that all cords of a system 
are subjected to the same body 
environment resulting in the same 
material behavior for all cords. 
GPC for the cord only 
Analysis only performed on samples ≥ 12 
months because no significant changes 
were identified up to 19 months in-vivo 
[4, 5, 7]. 
One non-contact area of one 
representative sample. 
It is assumed that all cords of a system 
are subjected to the same body 
environment resulting in the same 
biostability behavior for all cords. 
4.4 Acceptance Criteria 
Since this protocol applies to a retrieval analysis and not to testing there are no acceptance criteria. 
Only the current condition of the received retrievals, including the identification of structural 
failures, will be documented. 
5 REPORTING 
A Zimmer Research Report (ZRR) will be created to document the retrieval analysis of every 
received case. 
 
A copy of the ZRR(s) will be sent to the Zimmer Spine Clinical Affairs Section 522 Clinical Study 
Manager for analysis and inclusion in the Dynesys Section 522 Post-Market Surveillance Study 
final report documenting device failure, patient demographics, and clinical circumstance. Any 
trends or correlations between device failure, patient demographics, and clinical circumstances will 
be documented in the Section 522 final study report. 
 
A summary report of the received cases will be written after 12, 24, and 36 months. This report 
should summarize all the findings and results from the retrieval analysis, including identification 
of structural failures. The report should also include a section to propose modification of the test 

ZRP_WI_1856_10_Rev 1 
Page 9 of 9 
protocol for the retrieval analysis if necessary. This may include additional test(s), to omit existing 
tests, or to perform tests only after a certain time in-vivo.  
6 REFERENCES 
[1] 
ISO 12891-1 (2011) Retrieval and analysis of surgical implants -- Part 1:  
 
Retrieval and handling 
[2] 
ISO 12891-2 (2000) Retrieval and analysis of surgical implants -- Part 2:  
 
Analysis of retrieved metallic surgical implants 
[3] 
ISO 12891-3 (2000) Retrieval and analysis of surgical implants -- Part 3:  
 
Analysis of retrieved polymeric surgical implants 
[4] 
ZRR_WI_0737_07 Analysis of Dynesys Pedicle Screw, Spacer, and Cord  
Retrievals from a U.S. IDE Study 
[5] 
Trommsdorff U., Köttig P. Analysis of retrievals of the Dynesys dynamic stabilization 
system for the spine, EuroSpine 2005, 7th Annual Meeting of the Spine Society of 
Europe, Vol. 14, Suppl. 1, Sep. 2005, SP 33 
[6] 
Petrini, P., Tanzi M. C., Zurbrügg, D Structural characterisation of retrieved PCU 
spacers used in a spinal implant system, 7th World Biomaterials Congress, 2004, p 1858 
[7] 
Trommsdorff U., Zurbrügg D., Schneider W. Biostability of Poly(Ethylene-
Terephthalate) cords used in a spinal implant system, 7th World Biomaterials Congress, 
2004, p 1864 
[8] 
lnformed Consent for the use of retrieved implants 
7 APPENDICES 
8 REVISION HISTORY 
In Revision 1 of this protocol the following changes were made: 
 
• 
On the cover page a signatory for Regulatory Affairs had to be updated. 
• 
On the cover page a signatory for Research had to be updated. 
• 
On page 2 under chapter 3 Handling of Retrievals section Revision surgery it was added 
that patient consent is only necessary for patients outside the US. 
• 
On page 3 under chapter 3 Handling of Retrievals section Note it was added that patient 
consent is only necessary for patients outside the US. 
• 
On page 9 under chapter 6 References in reference [1] the version of the ISO was updated 
and in reference [8] the word spinal was deleted. 
 

 
 
 
 
 
 
 
 
 
IMAGING PROTOCOL: 
Post Market Surveillance for the Dynesys® Spinal 
System, Assessing Safety and Fusion. 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CMU2010-10S 
September 20, 2010 
 
 
 
 
Sponsor: 
Zimmer Spine, Inc. 
7375 Bush Lake Road 
 
Edina, MN  55439 
 
 
 
 
 
 
 

 
CMU2010-10S 
September 20, 2010 
Page 2 of 5 
 
 
I. 
STUDY PURPOSE 
To assess the safety profile and fusion rates following posterior lateral fusion with the Dynesys ® 
Spinal System as an adjunct to fusion compared to literature control.   
 
 
II. 
RADIOGRAPHIC IMAGING 
 
Subjects will undergo standard evaluations at specified pre- and post-operative time points. The 
radiographic imaging schedule is presented in Table 1 below.  Plain film imaging will include Neutral 
Lateral, Neutral AP and Flexion-Extension.   
 
Table 1:  Radiograph Schematics 
 
Pre-Op 
Surgery 
6M 
12M 
24M 
Annual 
 
-4 weeks 
 
±4 
weeks 
±8 
weeks 
±8 
weeks 
±8 
weeks 
Radiographs 
(AP, NL, Flexion, 
Extension) 
X 
 
X 
X 
X 
X 
Radiographic 
Assessment  
X 
 
X 
X 
X 
X 
 
 
A. Quality Assurance 
Unless limited by subject or equipment constraints, plain radiographs will be obtained with the 
subject in a standing position.  The subject will be instructed to move in the directed position to the 
maximum extent possible.  The radiology technician and study coordinator will ensure that the 
views exhibit minimal out-of-plane effects, that all relevant levels are visible and that the films are 
properly labeled.   
 
The films will be used to evaluate device condition and to detect the presence of device-related 
complications including retrolisthesis, spondylolisthesis, instability, degeneration, radiolocency, 
bridging bone and fusion status.  The radiographs will also be used to quantify certain radiographic 
parameters including translations, angular range of motion and bridging bone.   
 
Quantitative and qualitative radiographic assessments will be collected pre-operatively and at the 
follow-up intervals through 24 months and annually thereafter until the last patient has completed 
follow-up.    
 
 
III. 
DATA COLLECTION & TRANSMITTAL 
The investigational sites will produce the films identified in Table 1 and will send via Fed Ex to Zimmer 
Spine, Clinical Affairs, 5251 W 73rd Street, Edina, MN  55439 within 15 days of evaluation, as stated in 
the protocol.   
 
 
A. Image Collection 
Sites will label each film and film jacket and/or CD and disc envelope with the patient ID, visit ID 
(PreOp, 6M, 12M, 24M, annual), the visit date and the views (AP, NL, Flexion, Extension).   The 
label should be attached to the film in such a way that it does not obscure the anatomy.  If possible, 
the film label should be placed over the patient identifiers to mask this information.  It may be 
necessary to redact the patient identifiers by other means if the film label fails to achieve this 
purpose.  Additionally, be sure to identify the patient’s right and left side.  This is mandatory on AP 

 
CMU2010-10S 
September 20, 2010 
Page 3 of 5 
 
views. 
 
Images for specific subject visits should be stored on a single film or CD.  If possible, a single CD 
should contain only the images obtained during a single visit.  It is recommended that images be 
stored in DICOM format.   
 
B. Shipment 
 
All digital images and plain films shipped to Zimmer Spine must be accompanied with a memo 
stating the inventory of all images contained in the shipment.  Images will not be returned to the 
site, therefore ensure all copies are made prior to shipment.     
 
C. Data Management 
Upon receipt, Zimmer Spine Data Management will verify the content and labeling of the films, 
verify the visit dates to ensure that all films are dated chronologically by designation, verify the visit 
views to ensure that all views are correctly labeled and that there are no missing films, verify film 
receipt logs to ensure that each set of films is stored and accounted.   
 
Access to films and associated study data will be restricted to authorized personnel only.   
 
Data Management will send an inventory report, case report forms and radiographs to independent 
reviewers every six months for review.   
 
 
IV. 
REVIEWERS 
The first assessment will be completed at the site by a radiologist.  The second assessment of 
radiographic bridging and device condition will be performed by independent radiographic reviewers. 
The independent reviewers shall be a board-certified, fellowship-trained and practicing radiology with 
no financial interest in Zimmer Spine.  
 
The reviewers shall be fully trained on the schedule of radiographic assessments and the classification 
system for performing each assessment. The reviewers shall be trained on the radiographic features of 
the treatment, its design, the clinical indications for its use and the relevant inclusion/exclusion criteria. 
The independent reviewers will not have access to clinical outcomes data when conducting the 
assessments. 
 
All independent reviewers’ determinations regarding the bone bridging, fusion status and additional 
observations are final and supersede preliminary judgments made by each site investigator. 
 
 
V. 
DIAGRAM AND DESCRIPTION OF MEASUREMENTS 
The following descriptions summarize how the measurements will be performed.  Data will be collected 
on paper case report forms provided to the reviewers. 
 
A. Disc Angle 
Disc Angle is the angle formed between the endplates of adjacent vertebrae as shown in Figure 1.  
Disc Angle will be measured on neutral lateral radiographs to assess local segmental lordosis.  
Disc Angle will also be measured on flexion and extension radiographs to assess angular range of 
motion.  Disc Angle will be reported in units of degrees. 
 

 
CMU2010-10S 
September 20, 2010 
Page 4 of 5 
 
Figure 1:  Disc Angle Diagram 
 
B. Angular Motion  
Angular range of motion will be calculated from lateral flexion-extension radiographs in accordance 
with Figure 2.  As described above, Disc Angle is the angle between the endplates of adjacent 
vertebrae.  The change in Disc Angle from flexion to extension determines the angular range of 
motion.  Angular Motion will be reported in units of degrees. 
 
Figure 2:  Angular Motion Diagram 
 
 
C. Translational Motion 
Translational motion will be calculated from flexion-extension radiographs in accordance with Figure 
3.  Translational motion is defined as displacement of the posterior-inferior corner of the superior 
vertebra in a direction defined parallel to the superior endplate of the inferior vertebra.  Translational 
Motion will be reported in units of millimeters. 
 
Figure 3:  Translational Motion Diagram 
 
 
D. Bridging Bone 
Bony Bridging will be graded as “Absent, Present or Unclear’ in accordance with the definitions 
provided below.  Bridging will be defined as a continuous connection of mineralized tissue from the 
superior to the inferior vertebral body. 
 
Absent:  Absence of continuous bridging bone from endplate to endplate 
Present: Presence of continuous bridging bone from endplate to endplate 

 
CMU2010-10S 
September 20, 2010 
Page 5 of 5 
 
Unclear:  No determination or absence or presence of continuous bone bridging can be made 
based on the provided radiographs 
 
There is no scientific consensus concerning the minimum threshold of bridging required to classify a 
level as solidly bridged.  Therefore, discretion will be left to the radiologist to determine whether 
sufficient bridging exists to render an affirmative assessment. 
 
E. Fusion Status 
Fusion Status will be graded as ‘Fused or Not Fused’.  Fusion Status will be derived from a logical 
analysis of the following factors: bony bridging, angular motion and translational motion. 
 
Not Fused:  No evidence of bridging bone between the involved vertebral endplates and ≥ 5º 
total angular motion and ≥3 mm translational motion 
Fused:  Evidence of bridging bone between the involved vertebral endplates and <5º total 
angular motion and <3 mm translational motion 
 
Fusion Status will be reported for each treated level.   
 
F. Other Radiographic Observations 
Additional incidental observations or noteworthy findings will be documented at the radiologist’s 
discretion and may include observations of screw/device loosening, lucency, malplacement or 
broken.  Additional observations of spondylolithesis, retrolistesis, degeneration, fracture and 
arthrodesis will be identified.  Clarifying remarks regarding the assessments will also be provided, 
including the location/type of failure/condition. 
 
 
 

 
Dynesys® Spinal System and the 
Zimmer® DTO Implant  
Instructions for Use 
 
Important information for the operating surgeon 
 
 
 
 
Zimmer GmbH 
P.O. Box 
CH-8404 Winterthur, Switzerland 
Telephone +41/ (0)52 262 60 70 
Fax 
+41/ (0)52 262 01 39 
www.zimmer.com 
Manufacturer: 
Zimmer GmbH 
Sulzer-Allee 8 
CH-8404 Winterthur, Switzerland 
 
Distributed in the USA by: 
Zimmer Spine, Inc. 
7375 Bush Lake Road 
Minneapolis, MN 55439-2027, USA 
Telephone 
(800) 655-2614 
 
(952) 832-5600 
Fax 
(952) 832-5620 
Art. No. D011 500 217 - e - Ed. 10/09 
1.0 Description 
When used as a pedicle screw fixation system, the Dynesys Spinal System is intended to provide immobilization 
and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic 
instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective 
evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).  The Dynesys Spinal System is 
comprised of a variety of pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for 
each individual case. The pedicle screws are manufactured from medical grade titanium alloy conforming to ISO 
5832-11. They are provided with or without hydroxyapatite coating conforming to ISO 13779-2. The tensioning 
cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured 
from Sulene-PCU (polycarbonate-urethane).  
The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of 
the fastening pin. The U & I Corporation Optima ZS Transition Screw is a transition pedicle screw that is part of the 
Optima ZS Spinal System. The Zimmer DTO Implant is used as an interface device when the Dynesys Spinal System 
and the Optima ZS Spinal System are implanted at adjacent levels. The tensioning cords are manufactured from 
Sulene-PET. The rod and pin are manufactured from Ti-6Al-4V conforming to IS0 5832-3. For information on the 
intended use, device description and materials for the Optima ZS Spinal System and the Optima ZS Transition Screw 
refer to the U & I Corporation's Instructions for Use for the Optima ZS Spinal System. 
Before using the Dynesys Spinal System alone or in combination with the Zimmer DTO Implant the 
operating surgeon should study carefully the following recommendations, warnings and instructions, as 
well as the product-specific information.  
Any complications or other effects that may occur for reasons such as incorrect indications or surgical 
technique, unsuitable choice of material or treatment, inappropriate use or handling of the instruments, 
sepsis, etc., fall within the responsibility of the operating surgeon; the manufacturer, the importers or the 
suppliers of Zimmer products cannot be held liable for same. 
Zimmer products should be implanted only by operating surgeons who are familiar with the general problems of 
spinal surgery and who are able to master the product-specific surgical technique.  
Implants are always components of a system. They should only be combined with other components belonging to 
the same system or as defined in the surgical technique, and may be implanted only using original instruments also 
belonging to the same system unless otherwise indicated. 
• Occasional exceptions to the above rules are pointed out in the description of the surgical technique or in the 
product description. 
• Zimmer Companies implants and implant parts should never be combined with parts from other companies, 
unless otherwise indicated in the Instructions for Use and/or the Surgical Technique Manual. General use 
EN_D011 500 217 Ed. 10/09 
Page 1 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 

 
operating room instruments and/or other instruments described in the surgical technique are permitted for use. 
In addition, when using the Zimmer DTO Implant it is permitted to combine the Dynesys Spinal System with the 
Optima ZS Spinal System. Each system must be implanted using the appropriate instruments and surgical 
technique as defined in the respective Surgical Technique Manuals. The instruments for the different systems 
must not be commingled or used interchangeably. 
• Spinal implants must not be machined or altered in any way, unless instructed to do so in the surgical technique. 
• Implants or implant-parts that are contaminated, not sterile, damaged, scratched or have been improperly 
handled or altered without authorization may not be implanted under any circumstances. 
2.0 Indications, Contraindications and Potential Adverse Events. 
• An implant should only be considered if all other therapeutic possibilities have been carefully considered and 
found unsuitable or inappropriate. 
• Any implant is subject to unavoidable wear and aging. In the course of time, an implant initially implanted in a 
stable manner can loosen or its functionality can become impaired. Wear, aging, loosening and so on can lead 
to the need for re-operation. 
• The selection of patients depends to a great extent on the age of the patient, his/her general state of health, the 
condition of the existing bone, previous operations and anticipated further surgery. Normally speaking, prosthetic 
replacements are only indicated for patients whose skeleton is fully developed. 
• For the indications, contra-indications and potential adverse events of the Optima ZS Spinal System refer to the 
Instructions for Use for that system. 
2.1 Indications  
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to 
provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following 
acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:  degenerative spondylolisthesis 
with objective evidence of neurologic impairment, and failed previous fusion (pseudarthrosis).  
In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:  
• 
Who are receiving fusions with autogenous graft only; 
• 
Who are having the device fixed or attached to the lumbar or sacral spine; 
• 
Who are having the device removed after the development of a solid fusion mass. 
 
When the Dynesys Spinal System and the Optima ZS Spinal System are used on contiguous levels, they must be 
used with the Zimmer DTO Implant, rod-cord combination implant, and the U & I Corporation Optima ZS Transition 
Screw.  The intended use for each level is as specified for each system. 
2.2 Contraindications 
Contraindications of the Dynesys Spinal System and the Zimmer DTO Implant are similar to other commercially 
available posterior spinal fixation systems. Contraindications include but are not limited to the following: 
• 
Use in the cervical spine; 
• 
Active systemic or local infection; 
• 
Obesity; 
• 
Pregnancy; 
• 
Mental illness; 
• 
Severe osteoporosis or osteopenia; 
• 
Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate; 
• 
Alcohol or drug abuse; 
• 
Patient unwilling or unable to follow postoperative instructions; 
• 
Soft tissue deficit not allowing sound closure; 
• 
Any medical or physical condition that would preclude the potential benefit of spinal implant surgery; 
• 
Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has 
the potential to decrease the useful life of the device; 
• 
Any medical or mental condition which would exclude the patient at high risk from surgery of this severity; 
• 
For pedicle screw cases, inadequate pedicles of the thoracic, lumbar, and sacral vertebrae. 
EN_D011 500 217 Ed. 10/09 
Page 2 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 

 
2.3 Complications and Possible Adverse Events 
Prior to surgery, patients should be made aware of the following possible adverse effects in addition to the potential 
for additional surgery to correct these effects: 
• 
Loosening, disassembly, bending or breakage of components; 
• 
Tissue sensitivity to implant material; 
• 
Potential for skin breakdown and/or wound complications; 
• 
Non-union or delayed union; 
• 
Infection; 
• 
Nerve damage, including loss of neurologic function, dural tears, paralysis, paresthesia, and cerebral spinal 
fluid leakage; 
• 
Fracture of vertebrae; 
• 
Foreign body reaction (allergic) to components or debris; 
• 
Loss of fixation; 
• 
Vascular or visceral injury; 
• 
Change of normal spinal curvature; 
• 
Gastrointestinal, urological and/or reproductive system compromise; 
• 
Pain or discomfort; 
• 
Bursitis; 
• 
Decrease in bone density due to stress shielding; 
• 
Loss of bone or fracture of bone above or below the level of surgery; 
• 
High removal torques may be encountered with the use of the hydroxyapatite coated screw; 
• 
Bone graft donor site pain, fracture, and/or delayed wound healing; 
• 
Restriction of activities; 
• 
Lack of effective treatment of symptoms for which surgery was intended; 
• 
Death. 
3.0 Warnings 
The safety and effectiveness of the Dynesys Spinal System and the Zimmer DTO Implant have not been 
established for spinal indications beyond those stated in the Indications section. 
The safety and effectiveness of this device has not been established for the intended use of spinal 
stabilization without fusion.  This device is only intended to be used when fusion with bone graft is being 
performed at all instrumented levels. 
 
For a complete list of Warnings and Precautions for the Optima ZS Spinal System, including the Optima ZS 
Transition Screw, refer to the Instructions for Use for that system. 
3.1 Precautions 
Only experienced spinal surgeons with specific training in the use of the Dynesys Spinal System, the Zimmer DTO 
Implant and the Optima ZS Spinal system should perform the implantation of these systems.  This is due to the 
technically demanding procedure presenting a risk of serious injury to the patient.  These systems should only be 
used with instrumentation specifically designed for each system.  Refer to the respective surgical techniques to 
determine which instruments should be used for each step of the surgical procedure. 
Unless the Zimmer DTO Implant is being used, components of spinal fixation systems other than Zimmer Companies 
should not be used with the components of the Dynesys Spinal System. Only the Optima ZS Spinal System, including 
the Optima ZS Transition Screw, may be used in combination with the Zimmer DTO Implant. 
No component of the Dynesys Spinal System and the Zimmer DTO Implant should be reused or re-sterilized.   
The Dynesys Spinal System and the Zimmer DTO Implant are intended to be used with bone graft, which is 
required to provide additional spinal support.  A successful result is not always achieved in every surgical case.   
The patients should be made aware that a successful result, as defined by reduced pain, increased function and 
the establishment of solid fusion, is not always achieved in every surgical case.  Proper patient selection will greatly 
affect the results.  Patients who smoke have been shown to have an increased incidence of non-union.  These 
EN_D011 500 217 Ed. 10/09 
Page 3 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 

 
patients should be informed of this increased risk and counselled to discontinue tobacco use prior to and 
immediately after surgery.  Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spinal 
fusion.  Patients with poor muscle tone and bone quality, and/or nerve paralysis are also poor candidates for spinal 
fusion.  The use of autogenous bone graft has been shown to provide superior results compared to the use of 
allograft bone graft material. 
In addition to the above specified warnings and precautions, general surgical risks should be explained to the 
patient prior to surgery. 
3.2 Preoperative 
• 
Only patients that meet the criteria described in Indications section and that do not have any conditions included 
in the Contraindications section of this package insert should be selected for surgery. 
• 
Implants of this system must be handled and stored to avoid damage.  Implants should be protected from 
damage including scratches, nicks and corrosive environments. 
• 
The surgeon should be instructed on the proper use of instruments and implants. 
• 
The doctor must explain the risks of a spinal implant to the patient, including the possible impact of the factors 
mentioned under Section 2.3 on the success of the operation and the possible side effects. The patient should 
also be informed as to what steps he/she can take in order to reduce the possible effects of these factors. 
 
Note: The Dynesys Spinal System, the Zimmer DTO Implant and the Optima ZS Spinal System Surgical Technique 
Manuals should be followed carefully.  Important information on the proper usage of implants and instrument are 
included. 
3.3 Intraoperative 
• The surgeon must follow the instructions provided in the surgical technique manual for the Dynesys Spinal 
System, the Zimmer DTO Implant and / or the Optima ZS Spinal System. Extreme caution must be used around 
the spinal cord and nerve root, especially during insertion of screws. 
• A correct choice of the implant is extremely important. The appropriate type and size of an implant for the 
individual patient must be selected, taking anatomical and biomechanical factors into account. 
• Aseptic handling is to be observed during the implantation.  Implants removed from a patient should never be re-
sterilized or reused. 
• The Zimmer DTO Implant requires specific assembly; refer to the respective Surgical Technique Manual for the 
assembly instructions.   
• When using the Zimmer DTO Implant, surgeon must be cautious about verifying that no component of the 
implant has become loose in the packaging, if the Zimmer DTO Implant components have become loose in the 
packaging please return the implant to Zimmer. 
• Verify that the Zimmer DTO Implant is fully assembled prior to implantation. 
• Remove any protective devices prior to implantation (i.e. protective caps or bags). 
• The Zimmer DTO is supplied pre-bent and must not be further contoured. 
EN_D011 500 217 Ed. 10/09 
Page 4 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 

 
3.4 Postoperative 
• Implant removal should be considered after fusion has occurred.  The risk and benefit of a second surgical 
procedure must be evaluated carefully.  The surgeon is expected to supply postoperative care and management 
instructions to the patient.  The patient should be advised that non-compliance with post-operative instructions 
could lead to poor results, including implant failure. 
• The patient must be adequately instructed regarding the risks and limitations of this implant system.  Additional 
surgeries may be required if fusion does not occur and implant failure occurs. 
• Patient must be instructed on the physical limitations that are required to avoid placing excessive stress on the 
implant causing implant failure or delays in recovery. 
• The patient must be informed that the risks of multiple complications do exist. 
• Components of this system are only intended to support the spine during the period required to achieve solid 
spinal fusion. 
• Regular X-ray checks are recommended in order to detect any changes in the position of the implant and signs 
of loosening or breakage of components. 
• The patient should be urged to inform his doctor immediately of any unusual changes to the operated area. 
• An implant-bearer’s card should also be made out for the patient 
 
3.5 MRI Compatibility 
• The patient must be told that implants can affect the results of computer tomography (CT) or magnetic 
resonance imaging (MRI) scans. 
• The DEVICE has not been evaluated for safety and compatibility in the MR environment. 
• The DEVICE has not been tested for heating or migration in the MR environment. 
 
4.0 Sterilization 
The Dynesys Spinal System and the Zimmer DTO Implants are Gamma-sterilized. Before the implant is used, the 
expiration date for sterility, indicated in the bar code or on the package label must be noted and the protective 
packing and the sterile packing must be checked for damage. Implants are provided ready to use, therefore, 
cleaning is not required. Implants must not be re-cleaned, re-sterilized or industrially processed for re-use 
after the surgery. Re-sterilization of synthetic materials/components can cause deterioration of the material. 
 
Refer to the Optima ZS Spinal System Instructions for Use for instructions on the cleaning and sterilization of the 
Optima ZS Spinal System and the Optima ZS Transition Screw. 
 
Warning:  Do not sterilize the Optima ZS Transition Screw tray with the Zimmer DTO Instrument Tray.  The 
effectiveness of these two trays together has not been established.  Refer their respective sterilization instructions. 
 
5.0 Storage and Handling 
• Implants must be stored in their original packaging, unopened. 
• Before implants are removed from their packaging, the protective wrapping must be examined for possible 
damage as this could jeopardize their sterility. If an expiration date for sterility of the product is indicated, this 
must be observed. If the packaging is damaged or the sterility expiration date has been reached, the implants 
must not be used and must be returned to the manufacturer. 
• Protective caps or other protective devices must not be removed until immediately before use. 
• Implants are extremely sensitive to damage. Even small scratches or marks left by impacts on the surfaces will 
cause excessive wear or breakage and can give rise to complications. Extremely careful handling is therefore 
strongly recommended. 
• Any additional instructions (e.g. adhesive instruction labels on the packaging) are to be followed. 
 
Refer to the Optima ZS Spinal System Instructions for Use for instructions for proper storage and handling of the 
Optima ZS Spinal System and the Optima ZS Transition Screw. 
6.0 Caution 
EN_D011 500 217 Ed. 10/09 
Page 5 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 

 
EN_D011 500 217 Ed. 10/09 
Page 6 of 6 
© Zimmer GmbH, 2009 
SAP Document 90204 Rev. 01 
 
United States (Federal) law restricts these devices to sale by or on the order of a physician. 
7.0 Additional Information 
If further information is required, please contact Zimmer Spine, Inc. 
8.0 Pictograms 
 
 
Symbol for «Follow the Instructions for Use» 
 
 
Symbol for «Not to be re-used» 
 
 
Symbol for «To be used by…» (Year, Month) 
 
 
Symbol for «By Prescription Only» 
 
 
Symbol for «Manufacture Date» 
 
 
Symbol for «Manufacturer» 
not sterile   
Symbol for «Contents packed without sterilization» 
STERILE R   
Symbol for «Sterile» and «Sterilization by radiation» 
9.0 Trademarks 
Optima™ ZS is a trademark of U&I Corporation.  
All other names, trademarks, service marks and logos referred to within this package insert are the property of Zimmer Inc. and/or 
their respective subsidiaries. 
 

Dynesys
® 
Top-Loading
System
The Dynamic Stabilization System
Surgical Technique

2
Dynesys® Top-Loading Surgical Technique
The Dynamic  
Stabilization System
Please refer to the Dynesys® 
Top-Loading Spinal System package 
insert for the Instructions for Use/
indications, device description, 
contraindications, precautions, 
warnings and potential risks 
associated with the Dynesys TL 
System.
Dynesys Instruments
• Implant Trial
• Bone Awl
• Cannulated Bone Awl
• Cannulated Pedicle Probe
• Depth Sleeve
• Pedicle Sound
• Cannulated Bone Taps
• T-Handle
• Pedicle Screw Driver
• Ratcheting Handles
• Pedicle Distance Gauge
• Spacer Cutter
• Spacer Cutter Handle
• Guide Pin
• Guide Pin Wrench
• 0° Glide
• 7° Glide
• Spacer Holder
• Spacer Pusher
• 7° Cord Guide
• Set Screw Driver
• Set Screw Torque Indicating Handle
• Cord Tensioner

3
Dynesys® Top-Loading Surgical Technique
The Dynesys TL Spinal System is composed of 
pedicle screws, universal spacers and cords.
Pedicle Screws:  The screws anchor the 
Dynesys TL System into the spine.
Universal Spacers:  The spacers are used 
to hold the segments in a more natural 
anatomical position and to control the spine in 
extension. 
Cords:  The cord controls forward
flexion movements.
Pedicle Screw:
PROTASUL
®-100 (Titanium alloy)
Universal Spacers: 
SULENE
® PCU  
(Polycarbonate-urethane)
Pedicle Screws
Twenty screw sizes are available:
	
5.2 mm	
6.0 mm	
6.4 mm	
7.2 mm	
8.0 mm
	
Diameter	
Diameter	
Diameter	
Diameter	
Diameter
 5.2 x 35 mm 
6.0 x 35 mm 
6.4 x 35 mm 
7.2 x 35 mm 
8.0 x 35 mm
 
 
6.0 x 40 mm 
6.4 x 40 mm 
7.2 x 40 mm 
8.0 x 40 mm
 
 
6.0 x 45 mm 
6.4 x 45 mm 
7.2 x 45 mm 
8.0 x 45 mm
 
 
6.0 x 50 mm 
6.4 x 50 mm 
7.2 x 50 mm 
8.0 x 50 mm
 
 
 
6.4 x 55 mm 
7.2 x 55 mm 
8.0 x 55 mm
Note: A screw with a diameter greater than 6.0 mm is recommended for good anchorage in the 
sacrum.
Note: 8.0 mm screws should be used for revisions only.
Use the largest diameter and longest length screw possible according to the 
patient's anatomy. Consider the individual patient's case when selecting a 
screw.
Cord: 
SULENE
® PET  
(Polyethylene-terephthalate)

4
Dynesys® Top-Loading Surgical Technique
Patient Positioning
Prone or Knee-Chest positions are 
acceptable provided that care is taken 
to preserve the natural lordosis of the 
lumbar spine. Avoid any pressure on 
the abdominal cavity that might result 
in excessive bleeding.
The use of fluoroscopy for placement of 
the screws is strongly recommended.
Other valid computer-aided surgical 
navigation techniques may also be 
used.
Incision
Two Options:
Midline Approach:
Make a lumbar median incision over 
the spinous processes of the vertebrae.
Make the incision one segment longer 
(proximal and distal) than the planned 
operative level(s).
Move the musculature aside from the 
spinous process.
Paraspinal Approach:
The Paraspinal Intermuscular Approach 
is the preferred minimally invasive 
technique to be used (without bone 
decompression indication).
Incision Choices:
Use a midline incision over the spinous 
processes of the vertebrae.
OR
Make two cuts 3.5 cm lateral from the 
spinous processes of the vertebrae.
Open the dorsal fascia.
Split up the muscles (L1-L3 between 
Multifidus and Longissimus L4-S1 
between Illiocostalis and Longissimus).
Midline Approach 
Paraspinal Approach 

5
Dynesys® Top-Loading Surgical Technique
Preparation Before  
the Placement of the Pedicle Screws
Place the screws lateral to the facet joints.
Correct screw placement is absolutely 
necessary for optimal functioning of the 
system and for long term anchorage of the 
screws.
Use the Implant Trial to determine the correct 
position of the screws.
Note: The facet joints must remain intact.
Note: If there is not enough room for the spacer, you 
can remove bone from the lateral aspect of the articular 
process, preserving the capsule.
Option 1:
Pedicle Preparation and Screw 
Placement with K-wires
Pedicle Preparation with K-wires
The Dynesys TL System is designed for use 
with 1.6 mm K-wires with blunt ends.
Place K-wire into the vertebral body.
Caution: X-ray use is recommended when using 
K-wires and cannulated instrumentation to ensure 
proper positioning within the pedicle and vertebral 
body.
Note: Inspect the Cannulated Bone Awl, Cannulated 
Pedicle Probe, Cannulated Taps, and Pedicle Screw Driver 
prior to use to ensure the cannula is not occluded.
Place the Cannulated Bone Awl over the K-wire 
and open the pedicle with the Cannulated 
Bone Awl.
Note: The Cannulated Bone Awl is intended for use 
over a K-wire only.
Remove the Cannulated Bone Awl leaving the 
K-wire in desired position.
Implant Trial usage
Proper  Cannulated 
Awl placement
Proper lateral screw 
placement


6
Dynesys® Top-Loading Surgical Technique
Place the Cannulated Pedicle Probe over the 
K-wire and advance to create the channel for 
the screw.
The marks on the Cannulated Pedicle Probe 
help determine the appropriate screw lengths 
(35, 40, 45, 50 or 55 mm).
Note: Do not open the pedicle deeper than length of the 
intended screw (maximum screw length is 55 mm). Screw 
length depends on patient morphology.
Note: X-ray use is recommended.
Remove the Cannulated Pedicle Probe leaving 
the K-wire in desired position.	
Pedicle Tapping with K-wires
Note: Dynesys TL screws do not require tapping. Use of a 
Cannulated Bone Tap is optional.
Select appropriate sized Cannulated Bone Tap.
Place over K-wire, advance to pedicle entrance 
point and tap to the appropriate depth. 
Caution: 
• Always select the Bone Tap diameter that 
corresponds to the pedicle screw size to be 
implanted. 
• Inspect cannulated Bone Taps prior to use to 
ensure the cannula is not occluded.
• Do not tap beyond the length of the pedicle 
screw to be implanted. 
• X-ray use is recommended when using Bone 
Taps.
Remove Cannulated Bone Tap leaving K-wire in 
desired position.
The marks on the 
Cannulated Pedicle 
Probe will help 
determine the 
appropriate screw 
lengths (35, 40, 45, 50 
or 55 mm).
OPTIONAL:   
Depth Sleeve
If you have difficulty 
seeing the marks 
on the tip of the 
Cannulated Pedicle 
Probe, use the Depth 
Sleeve and the 
corresponding marks 
on the proximal end of 
the shaft.

7
Dynesys® Top-Loading Surgical Technique
Placement of the Pedicle Screws 
with K-wires
Set Up of the Pedicle Screw
Engage the Pedicle Screw Driver with the 
desired Ratcheting Handle.
Insert the screw onto the Pedicle Screw 
Driver. 
Ensure the Pedicle Screw Driver tangs are 
fully seated into the corresponding screw 
slots.
Caution: Avoid contact between glove and screw 
threads to ensure aseptic conditions.
Advance thumbwheel, turning clockwise to 
secure the screw to the Pedicle Screw Driver.
Caution: Do not over tighten.
Placement of the Pedicle Screws
Place desired screw and Pedicle Screw Driver 
over K-wire. 
Advance into the pedicle until the screw 
head or the polished portion of the screw is 
in contact with the bone.
Caution:
• Inspect the Pedicle Screw Driver and Ratcheting 
Handle prior to use to ensure the cannula is not 
occluded.
• Ensure the K-wire is properly positioned in the 
cannulated portion of the Pedicle Screw Driver 
when advancing the screw.
Caution: Upon insertion of the screw, do not 
reverse the screw to back it up.
Position the screws to allow for passage of 
the cord.
Caution: A torque and/or bending load that is too 
high can fracture the pedicle.
Note orientation of the Pedicle Screw 
Driver and the pedicle screw head.
<10 mm

8
Dynesys® Top-Loading Surgical Technique
Turn the thumbwheel counterclockwise to 
release the pedicle screw from the Pedicle 
Screw Driver.
Remove the Pedicle Screw Driver. 
After the first screw has been placed, use the 
Implant Trial to approximate the final position 
and orientation of the second screw head, and 
to ensure adequate room for the spacer.
Place all screws.  
Check the screw placement with fluoroscopy, 
x-ray or other valid computer-aided surgical 
navigation techniques.
You may either remove K-wires or leave in 
place to facilitate placement of the Guide Pin 
and construct assembly instruments.   
Proceed to the “Universal Spacer” section. 
Option 2:
Pedicle Preparation and Screw 
Placement without K-wires
Pedicle Preparation without K-wires
Open the pedicle with the Bone Awl.

9
Dynesys® Top-Loading Surgical Technique
Use the Cannulated Pedicle Probe to create 
the channel for the screw.
The marks on the Cannulated Pedicle Probe 
help determine the appropriate screw lengths 
(35, 40, 45, 50 or 55 mm). 
Note: Do not open the pedicle deeper than length of the 
intended screw (maximum length is 55 mm). Screw length 
depends on patient morphology.
Note: We do not recommend using a curved pedicle probe, 
which may widen the bone channel. 
Note: X-ray use is recommended. 
Check with the Pedicle Sound whether the 
pedicle wall is intact.
Pedicle Tapping
Note: Dynesys TL screws do not require tapping. Use of a 
Cannulated Bone Tap is optional.
Select appropriate sized Cannulated Bone Tap.
Advance to pedicle entrance point and tap to 
the appropriate depth.
Caution:
• Always select the Bone Tap diameter that 
corresponds to the pedicle screw size to be 
implanted.
• Inspect cannulated Bone Taps prior to use to 
ensure the cannula is not occluded.
• Do not tap beyond the length of the pedicle screw 
to be implanted.
• X-ray is recommended when using Bone Taps.
Remove the Cannulated Bone Tap.
OPTIONAL:   
Depth Sleeve
If you have difficulty 
seeing the marks on 
the tip of the Cannulate 
Pedicle Probe, use the 
Depth Sleeve and the 
corresponding marks 
on the proximal end of 
the shaft.

10
Dynesys® Top-Loading Surgical Technique
Placement of the Pedicle Screws 
without K-wires
Set Up of the Pedicle Screw
Engage the Pedicle Screw Driver with the desired 
Ratcheting Handle.
Insert the screw onto the Pedicle Screw Driver.
Ensure the Pedicle Screw Driver tangs are fully 
seated into the corresponding screw slots.
Caution: Avoid contact between glove and screw 
threads to ensure aseptic conditions.
Advance the thumbwheel, turning clockwise to 
secure the screw to the Pedicle Screw Driver. 
 
Caution: Do not over tighten.
Placement of the Pedicle Screws
Insert the screws.  It is important to place the 
screws lateral to the facets.
Advance the screw until the head or the polished 
portion of the screw is in contact with the bone. 
Caution:  Upon insertion of the screw, do not reverse 
the screw to back it up.
Position the screws to allow for passage of the 
cord.
Caution:  A torque and/or bending load that is too 
high can fracture the pedicle. 
Turn the thumbwheel counterclockwise to 
release the screw from the Pedicle Screw Driver.  
Remove the Pedicle Screw Driver.
Note orientation of the Pedicle Screw 
Driver and the pedicle screw head.
<10 mm

11
Dynesys® Top-Loading Surgical Technique
After the first screw has been placed, use the 
Implant Trial to approximate the final position 
and orientation of the second screw head, and 
to ensure adequate room for the spacer.
Place all screws.  
Check the screw placement with fluoroscopy, 
x-ray or other valid computer-aided surgical 
navigation techniques.
Universal Spacer
Measuring Spacer Length
Verify that the Drag Indicator on the Pedicle 
Distance Gauge is in the start position.
Place the Pedicle Distance Gauge between the 
screw heads at the bottom of the screw slots 
and measure the appropriate spacer length. 
Note: The Pedicle Distance Gauge allows measurement 
with or without the cord in place. 
Drag Indicator 
start position

12
Dynesys® Top-Loading Surgical Technique
Assess the movement in the facets in 
distraction and compression.
Measure the distance (spacer length) with a 
slight distraction force.
Possible guidelines: Distract to create parallel 
endplates or distract to create neutral 
facet joint position.
Caution: Do not induce kyphosis or scoliosis.
Note:  Fluoroscopy usage is highly recommended while 
measuring the spacer length.
Considering patient position, determine the 
desired spacer length for each side with light 
distraction or compression.
Record the measured spacer length for all 
levels. Spacer length measurement must be 
done on both sides before the cord and spacer 
are implanted.
Note:  Reset the Drag Indicator after each measurement. 
Failure to reset may lead to incorrect spacer measurement.
Cutting the Universal Spacer to Size
Use the Spacer Cutter to cut the spacer.
The spacer can only be cut once and is used 
only on one vertebral segment side. 
Spacer lengths can be cut from 6 mm to 45 
mm.
The Cutter Blade must be replaced if the 
cutting edge has deteriorated (nicks on the cut 
surface of the spacer).  Refer to Appendix A for 
instructions.
Remove the Lever from the tray.  Put the Lever 
into the Blade Holder.  Open the Cover while 
pressing the Unlock Button.

13
Dynesys® Top-Loading Surgical Technique
To open the channel for the spacer, press the 
Fast Shift Button and move the Adjustable 
Screw as far to the right as it will go.
 
Place the spacer groove into the slot provided 
on the Adjustable Screw.
Hold down the Fast Shift Button and push 
the Adjustable Screw to the left for the initial 
adjustment.
Note: The Blade Holder must be in the backward (open) 
position to adjust the Spacer.
Turn the Adjustable Screw to set the final 
desired length.
Alignment of the markers shows the actual size 
being cut. 
Close the Cover while pressing the Unlock 
Button.
Hold the Spacer Cutter with one hand and pull 
the Lever forward with the other hand until it 
stops.
Open the Cover while pressing the Unlock 
Button.

14
Dynesys® Top-Loading Surgical Technique
Discard the cut off portion of the spacer.
Remove the sized spacer.  Spacer length may 
be verified on the scale located on the top of 
the Spacer Cutter.
Note: Implant the spacer portion with the groove.
You may order an optional Spacer Organizer 
(P/N 07.01174.001) to organize cut spacers by 
placing them on a peg that corresponds to the 
correct level and side.
Cord
The cord is available in two sizes: 100 mm and 
200 mm.
Note: Use the 100 mm length for one level. Use the 200 mm 
length for two levels.
The cord is made up of three segments: the 
Introduction Zone, the Working Zone and the 
Functional Zone.
Note: The Introduction Zone is the thin part of the cord and 
should be positioned on the most cephalad side of the 
implant construct (100 mm length only).
Note: The Working Zone is wrapped in green thread and is 
intended to facilitate cord tensioning.
Note: With the Cord Tensioning Instrument, only work in the 
Working Zone.
Note: The Functional Zone is the part implanted into the 
patient.
Do not work with the Cord Tensioning 
Instrument in the Functional Zone.
The 100 mm cord has one Introduction Zone, 
one Working Zone and one Functional Zone.
The 200 mm cord has two Introduction Zones 
(one on each end), two Working Zones (next 
to the Introduction Zones) and one Functional 
Zone (in the middle of the cord).
Note: Handle the cord carefully to ensure aseptic conditions
100 mm Cord
200 mm Cord

15
Dynesys® Top-Loading Surgical Technique
Dynesys Glide Instrumentation:
Primary Level
The Dynesys Glide instruments are available in 
two angulations (0° and 7°) to accommodate 
various corresponding angles of screw conver-
gence.  
Dock 7° Dynesys Glide instrument to cephalad 
screw.
  
Dock 0° or 7° Dynesys Glide instrument to 
most caudal screw. 
Note: When the appropriate angled Dynesys Glide instru-
ments have been docked to the pedicle screws the two 
instruments should be parallel or slightly divergent.

16
Dynesys® Top-Loading Surgical Technique
Optional Guide Pin
The Guide Pin may be used to dock Glide 
instruments as required.  One end of the 
Guide Pin is terminated with threads to fix the 
Guide Pin to the screw.  The opposite end of 
the Guide Pin is terminated with a blunt end 
that provides a floating engagement with the 
screw. 
Note: If using the threaded end of the Guide Pin, do not 
over tighten. 
Use the Guide Pin Wrench to remove the Guide 
Pin from the screw. 
Note: It may be necessary to compensate for tissue pres-
sure when removing the Guide Pin.
Reduction of the Cord and Spacer
Attach the appropriately sized spacer to distal 
end of the Spacer Holder and advance sleeve 
to lock spacer into place.
Thread a 100 or 200 mm cord through spacer 
and position with the spacer in the Functional 
Zone.
Ensure a minimum of 20 mm of Functional 
Zone extends beyond the spacer on the caudal 
side.
When using the 100 mm cord the Introduction 
and Working Zone should be positioned 
cephalad.  
Note: Handle the cord carefully to ensure aseptic 
conditions.


Introduction and 
Working Zone 
cephalad

17
Dynesys® Top-Loading Surgical Technique
Place the spacer and cord between the 
Dynesys Glide instruments with the cord posi-
tioned into the Dynesys Glide instrument slots. 
Using the Spacer Holder, carefully advance the 
spacer towards the pedicle screws until fully 
seated.
You may use a mallet to gently tap against the 
Spacer Holder handle if desired. 
Note: While advancing the spacer, a slight distractive force 
may be applied with the Glide instrument handle.
Caution: A torque and/or bending load that is too 
high can fracture the pedicle.
Disengage and remove the Spacer Holder. 
Ensure the cord is placed properly into the 
Dynesys Glide instrument slots.   
Repeat contralateral side as desired. 

18
Dynesys® Top-Loading Surgical Technique
Placing and Tightening 1st Set Screw
0° Dynesys Glide Instrument
Reposition the cord as required ensuring 10 
mm extends beyond the most caudal screw. 
Assemble the Set Screw Driver to the Set 
Screw Torque Indicating Handle. 
The Set Screw Driver has a screw retaining 
feature and will hold the set screw securely 
when the set screw is properly placed.   
Insert the set screw onto the Set Screw Driver 
tip and inspect to ensure the screw is fully 
seated and secure.
Caution: Do not use bone wax to fix screw to Set 
Screw Driver.
Advance set screw through the 0° Dynesys 
Glide instrument into the pedicle screw. 
Note: Proper alignment is necessary to ensure set screw is 
properly engaged. Never force the set screw. Thread strip-
ping may result.

19
Dynesys® Top-Loading Surgical Technique
Place one hand on the 0° Dynesys Glide instru-
ment handle to provide anti-torque. 
Tighten set screw to final torque. 
Proper torque has been reached when the two 
arrows on the Torque Indicating Handle 
intersect.
Caution: Do not over or under tighten set screw.
Remove Set Screw Driver assembly and 0° 
Dynesys Glide instrument .
Note: It may be necessary to compensate for tissue pres-
sure when removing the 0° Dynesys Glide instrument.
7° Dynesys Glide Instrument
Reposition the cord as required ensuring 10 
mm extends beyond the most caudal screw. 
Place the 7° Cord Guide into the 7° Dynesys 
Glide instrument and advance until locked in 
place. 
Note: It may be necessary to temporarily remove the 
cephalad Dynesys Glide instrument to provide adequate 
clearance for the 7° Cord Guide.

20
Dynesys® Top-Loading Surgical Technique
Assemble the Set Screw Driver to the Set 
Screw Torque Indicating Handle. 
The Set Screw Driver has a screw retaining 
feature and will hold the set screw securely 
when the set screw is properly placed.   
Insert the set screw onto the Set Screw Driver 
tip and inspect to ensure the screw is fully 
seated and secure.
Caution: Do not use bone wax to fix screw to Set 
Screw Driver.
 
Advance set screw through the 7° Cord Guide 
into the pedicle screw. 
Note: Proper alignment is necessary to ensure set screw is 
properly engaged. Never force the set screw. Thread strip-
ping may result.
Place one hand on the 7° Dynesys Glide 
instrument handle to provide anti-torque. 
Tighten set screw to final torque.  Proper 
torque has been reached when the two arrows 
on the Torque Indicating Handle intersect.
Caution: Do not over or under tighten set screw.
Remove Set Screw Driver assembly and caudal 
7° Dynesys Glide instrument.
Note: It may be necessary to compensate for tissue pres-
sure when removing the 7° Dynesys Glide instrument.

21
Dynesys® Top-Loading Surgical Technique
Tension and Final Tighten Set Screw
Place the 7° Cord Guide into the 7° Dynesys 
Glide instrument and advance until locked in 
place.
Ensure cord is captured properly in the Cord 
Guide distal end. 
Place cord Working Zone through the Cord 
Guide slot. 
Insert the set screw onto the Set Screw Driver 
tip and inspect to ensure the screw is fully 
seated and secure.
Caution: Do not use bone wax to fix screw to Set 
Screw Driver.
Distal end of Cord 
Guide rests on cord

22
Dynesys® Top-Loading Surgical Technique
Feed cord through Cord Tensioner and place 
onto the 7° Cord Guide docking location.  
Advance set screw through the 7° Cord Guide 
into initial position on pedicle screw. Do not 
tighten screw at this time.
Squeeze tensioner handles to appropriate 
tension as indicated on the tensioner.  While 
maintaining cord tension, advance and tighten 
set screw to final torque. 
Proper torque has been reached when the two 
arrows on the Torque Indicating Handle inter-
sect.
Note: Proper alignment is necessary to ensure set screw is 
properly engaged. Never force the set screw. Thread strip-
ping may result.
Note: When properly docked the Cord Tensioner will 
provide anti-torque.
Caution: Do not over or under tighten set screw.
Cord Tensioner 
provides anti-torque in 
notch of Cord Guide

23
Dynesys® Top-Loading Surgical Technique
Remove Set Screw Driver assembly.
Remove Cord Tensioner.
Remove the assembled 7° Dynesys Glide 
instrument and Cord Guide.
Repeat Contralateral Side
Adjacent Segment
Refer to the next section of this document to 
implant and tension additional segment. 
When the entire construct is complete and the 
system is fully tensioned, cut the cords leav-
ing 10 mm of cord out of the screw heads and 
remove cut ends. 
Note: Only implant the Functional Zone of the cord.
Caution: Implantation of the Working or 
Introduction Zones in the patient could lead to cord 
failure.
Dynesys Glide Instrumentation:
Adjacent Level
Optional Guide Pin
The Guide Pin may be used to dock Glide instru-
ments as required.
One end of the Guide Pin is terminated with 
threads to fix the Guide Pin to the screw. 
The opposite end of the Guide Pin is terminated 
with a blunt end that provides a floating engage-
ment with the screw. 
Note: If using the threaded end of the Guide Pin, do not over 
tighten. 
Use the Guide Pin Wrench to remove the Guide 
Pin from the screw. 
Note: It may be necessary to compensate for tissue pressure 
when removing the Guide Pin.

24
Dynesys® Top-Loading Surgical Technique
Place and Reduce Spacer
Dock the 7° Dynesys Glide instrument to the 
cephalad screw. 
Use Guide Pin to dock instruments as required.
Thread cord through the appropriately sized 
spacer and place the spacer against caudal 
screw head. 
Ensure the cord is placed properly into the 7° 
Dynesys Glide instrument slot.   
Place the Spacer Pusher into the 7° Dynesys 
Glide instrument and advance until positioned 
in contact with spacer.
Advance the Spacer Pusher until spacer is in 
final position.
You may use a mallet to gently tap against the 
Spacer Holder handle if desired.
Note: Handle the cord carefully to ensure aseptic conditions.
Note: A slight distractive force may be applied with the 7° 
Glide instrument handle if necessary while advancing.
Caution:  A torque and/or bending load that is too 
high can fracture the pedicle.   
Remove the Spacer Pusher.
Reducing a Spacer Less than 12 mm in 
Length
Advance the Spacer Pusher until spacer is 
fully seated or the Spacer Pusher cannot be 
advanced further.
Caution: Carefully advance the Spacer Pusher when 
implanting a spacer less than 12 mm in length to 
avoid damaginging the pedicle screw.
Remove the Spacer Pusher.  Engage the distal 
end of the Spacer Holder and advance sleeve to 
lock spacer into place.  Using the Spacer Holder, 
carefully advance the spacer until fully seated.  
Disengage and remove the Spacer Holder.

25
Dynesys® Top-Loading Surgical Technique
Tension and Final Tighten Set Screw
Place the 7° Cord Guide into the 7° Dynesys 
Glide instrument and advance until locked in 
place.
Ensure cord is captured properly in the Cord 
Guide distal end. 
Place cord Working Zone through the Cord Guide 
slot. 
Insert the set screw onto the Set Screw Driver tip 
and inspect to ensure the screw is fully seated 
and secure.
Caution: Do not use bone wax to fix screw to Set 
Screw Driver.
Feed the cord through Cord Tensioner and place 
onto the 7° Cord Guide docking location.  
Advance the set screw through the 7° Cord 
Guide into initial position on pedicle screw. Do 
not tighten screw at this time.
Distal end of Cord 
Guide rests on cord

26
Dynesys® Top-Loading Surgical Technique
Squeeze the tensioner handles to appropriate 
tension as indicated on the tensioner. 
While maintaining cord tension, tighten the set 
screw to final torque. 
Proper torque has been reached when the two 
arrows on the Torque Indicating Handle inter-
sect.
Note: Proper alignment is necessary to ensure set screw is 
properly engaged. Never force the set screw. Thread strip-
ping may result.
Note: When properly docked the Cord tensioner will provide 
anti-torque.
Caution: Do not over or under tighten set screw.
Remove Set Screw Driver assembly.
Remove Cord Tensioner.
Remove the assembled 7° Dynesys Glide instru-
ment and Cord Guide.
Repeat Contralateral Side and Adjacent Segment 
as Desired.
When the system is fully tensioned, cut the 
cords leaving 10 mm of Functional Zone out of 
the screw heads and remove cut ends. 
Note: Only implant the Functional Zone of the cord.
Caution: Implantation of the Working or Introduction 
Zones in the patient could lead to cord failure.
Cord Tensioner provides 
anti-torque in notch of 
Cord Guide

27
Dynesys® Top-Loading Surgical Technique
Postoperative Treatment
It is the responsibility of the surgeon to assess 
the adequate postoperative treatment depend-
ing on the patient’s condition.
• Analgesics.
• Possible antibiotic prophylaxis against 
	  infection.
• Possible prophylaxis against 
	  thromboembolism.
• Early physiotherapy.
• Limited activity is recommended for 
	  approximately six weeks.
• A non-rigid brace should be considered during 
	  the period of limited activity.
• A gradual resumption of activities can begin
	  after approximately six weeks.
Hardware Removal/Revision 
Instructions
Note: It may be necessary to use general surgical instrumen-
tation to remove the implants.
Set Screw Removal
Engage the 0° Dynesys Glide instrument with 
the pedicle screw head of the set screw to be 
removed. Fully seat the Torque Indicating Handle 
and Set Screw Driver into the set screw. While 
providing anti-torque with the 0° Dynesys Glide 
instrument, turn the Set Screw Driver counter-
clockwise until the set screw is removed. Repeat 
for all set screws to be removed.

28
Dynesys® Top-Loading Surgical Technique
Spacer and Cord Removal
Slide the Spacer Holder sleeve into the open 
position and place onto the spacer to be 
removed. Carefully slide the Spacer Holder 
sleeve into the closed position and withdraw 
the spacer and cord. A slight rocking motion 
may be necessary to facilitate removal. Repeat 
for all spacers to be removed. Repeat on the 
contralateral side as desired.   
Pedicle Screw Removal 
Assemble the Ratcheting T-Handle and Pedicle 
Screw Driver and place onto the screw head 
using the marks located on the Pedicle Screw 
Driver to ensure proper orientation. Turn the 
Pedicle Screw Driver retainer nut clockwise and 
secure the screw to the Pedicle Screw Driver. 
Once the screw is fully engaged on the 
driver, carefully turn the Pedicle Screw Driver 
counterclockwise until the screw is removed. 
Repeat for all pedicle screws to be removed.   
Carefully examine the operative site and count 
implants to ensure all hardware has been 
removed.
APPENDIX A
Changing the Cutter Blade
Rotate the Blade Holder clockwise into the 
forward (cut) position.
Loosen the Screw on the Blade Holder using the 
Wrench Feature of the Spacer Cutter Lever.
Turn the Blade counterclockwise and pull it 
down, removing it from the Spacer Cutter. 
Take the new Replacement Blade and insert it 
into the Spacer Cutter as far as it will go.
Rotate the Replacement Blade clockwise as far 
as it will go.
Verify that the hole of the blade is properly 
aligned with the screw.
Tighten the screw with the Wrench Feature of 
the Spacer Cutter Lever.
Note: Do not over tighten the Blade Cutter Screw.

Contact your Zimmer Spine representative or visit us at www.zimmerspine.com
www.zimmerspine.com
L1393 Rev.C   ©2007 Zimmer Spine, Inc.   (851S-1001-00)
Zimmer Spine, Inc.
7375 Bush Lake Road 
Minneapolis, MN 55439-2027
U.S.A. 
Telephone 952.832.5600 
or 800.655.2614
Fax 952.832.5620 
The Dynesys Spinal System and Zimmer DTO 
Implant are manufactured by:
Zimmer GmbH	
Sulzer Allee/ P.O. Box
CH-8404 Winterthur
Switzerland
Tel:  41 (0)52 262 60 70
Fax: 41 (0)52 262 01 39

Because different stages of spinal degeneration  
require a different solution.
Zimmer® DTO™  
Implant and  
OPTIMA™ ZS  
Transition Screw 
with LIS Instruments
Surgical Technique

2
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Surgical Technique
Zimmer DTO and OPTIMA ZS 
Transition Screw
with LIS Instruments
Table of Contents
Foreword	
3
General Information	
3
Zimmer DTO Implant	
4
OPTIMA ZS Transition Screw	
5
Zimmer DTO Instruments	
5
Patient Positioning	
6
Approach	
6
Dynesys Screw Pedicle Preparation	
7
Dynesys Screw Placement	
8
OPTIMA ZS Transition Screw Placement	
9
OPTIMA ZS Screw Placement	
10
DTO Implant Selection	
10
DTO Implant Final Preparation before Insertion	
11
DTO Implant Assembly	
15
Compression/ Distraction	
17
Final Set Screw Tightening	
18
Dynesys Assembly	
21
Final Construct 	
23
Hardware Removal/Revision Instructions	
24
Postoperative Treatment 	
25
Cleaning Instructions	
25
Appendix 1	
26
Appendix 2	
27
Warnings and Precautions	
28

3
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Foreword
•	 This document describes the  
surgical technique to implant  
the Zimmer® DTO™ Implant and  
the OPTIMA™ ZS Transition Screw  
in combination with the Dynesys® 
and OPTIMA ZS Spinal Systems. 
•	 For implant selection and the 
complete respective surgical 
techniques of the Dynesys and 
OPTIMA ZS systems, please refer to:
–	Dynesys LIS Less Invasive Surgery, 
L1301
–	OPTIMA ZS Spinal Fixation System, 
L1264 
•	 When the Dynesys and OPTIMA ZS 
systems are used on contiguous 
levels, they must be used with 
the Zimmer DTO implant, rod-cord 
combination implant, and the 
OPTIMA ZS transition screw. The 
indication for use for each level is 
as specified for each system.
General information
•	 The Dynesys LIS instruments 
should only be used with the 
Dynesys Spinal System. OPTIMA 
ZS instruments should only be 
used with OPTIMA ZS screws. The 
Zimmer DTO implant and OPTIMA 
ZS transition screw should be used 
with DTO instruments, Dynesys 
LIS and OPTIMA ZS instruments 
according to the instructions for 
use described in this brochure. 
•	 For further information regarding 
indications, warnings, precautions, 
adverse events and other 
important medical information, 
please read the respective 
instruction leaflets for the systems.
 

4
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
DTO Implant 
The DTO implant and OPTIMA ZS 
transition screw are designed to 
allow the Dynesys and OPTIMA 
ZS systems to be implanted at 
contiguous levels of the lumbar 
spine.
The DTO implant is made of a 
combined 100 mm PET (Polyethylene-
Terephthalate) Dynesys cord and a 
titanium alloy 6 mm rod. The rod is 
pre-bent.
The DTO implant is delivered partially 
pre-assembled (cord inserted in the 
rod and maintained in position by 
means of a small needle). 
The assembly must be finalized  
intra-operatively by pressing the pre-
assembled pin with the DTO Hand 
Press.
The Dynesys cord must be carefully 
handled in order to maintain aseptic 
conditions during the assembly.
The DTO implant is available in four 
rod lengths: 
• 40 mm
• 50 mm
• 60 mm
• 80 mm
The DTO implant is delivered sterile.
 
 
The Dynesys system is placed 
cranially from the OPTIMA ZS system. 
The DTO implant is intended only for 
index surgery.
Zimmer DTO Implant
 OPTIMA ZS 
Transition Screw
DTO Implant

5
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
OPTIMA ZS Transition  
Screw
The polyaxial OPTIMA ZS transition 
screw is specially designed to be  
used with the DTO implant.
Available sizes:
	
6.0 mm	
7.0 mm  
	
Diameter	
Diameter
	 6.0 x 35 mm	
7.0 x 35 mm 
	 6.0 x 40 mm	
7.0 x 40 mm 
	 6.0 x 45 mm	
7.0 x 45 mm 
	 6.0 x 50 mm	
7.0 x 50 mm 
 
The OPTIMA ZS transition screw is 
delivered nonsterile.
Caution: The DTO implant can only be 
used in connection with the OPTIMA ZS 
transition screw. 
Zimmer DTO Instruments
Four DTO instruments are available:
DTO Hand Press
DTO Anti Torque
DTO Protective Adapter 
(for the DTO Compressor)
DTO Compressor
The specific instruments for Dynesys LIS and OPTIMA ZS systems are 
described in their respective surgical techniques.

6
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Patient Positioning
Prone or Knee-Chest positions are 
acceptable, provided that care 
is taken to preserve the natural 
lordosis in the lumbar spine as well 
as to avoid any pressure on the 
abdominal cavity that might result 
in excessive bleeding.
The use of fluoroscopy or X-ray 
(AP and lateral view) is strongly 
recommended for placement of the 
screws.
Other valid computer-aided surgical 
navigational techniques may also  
be used.
Approach
The spine is approached through  
a standard posterior midline 
incision or a paraspinal approach. 
Muscles are retracted until the facet 
joints are visible. 
Caution: Do not damage the posterior 
ligaments or the facet joint capsules.
Preparation Before the 
Placement of the Pedicle 
Screws
Place the screws lateral to the facet 
joints.
Correct screw placement is 
absolutely necessary for optimal 
functioning of the system and for 
long term anchorage of the screws.
Note: The facet joints must remain 
intact.
Note: If there is not enough room for the 
spacer, you can remove bone from the 
lateral aspect of the articular process, 
preserving the capsule. 
Use the Spacer Template to 
determine the correct position of 
the screws.
Open the pedicle with the Awl.
Spacer Template 
usage
Proper Awl 
placement

7
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Dynesys Screw
Pedicle Preparation 
The assembly is started at the most 
cranial level with the placement of 
the Dynesys pedicle screws. 
Using the Dynesys Awl and the  
Pedicle Probe, prepare the pedicle  
for insertion of the screw. 
The marks on the Pedicle Probe 
help determine the appropriate 
screw lengths (35, 40, 45, 50 or 55 
mm).
Note: Do not open the pedicle deeper than 
length of the intended screw (maximum 
screw length is 55 mm). Screw length 
depends on patient morphology.
Note: We do not recommend using a curved 
Pedicle Probe, which may widen the bone 
channel.
Note: X-ray use is recommended.
Check the integrity of the pedicle  
wall with the Pedicle Sound.
Note: Dynesys screws do not require tapping. 
Use of the Dynesys Bone Tap System is 
optional.
Caution: X-ray use is recommended when 
using Bone Taps. Always select the Bone Tap 
diameter that corresponds to the pedicle 
screw size to be implanted. Do not tap 
beyond the length of the pedicle screw to 
be implanted. Inspect cannulated Bone Taps 
prior to use to ensure the cannula is not 
occluded.
Proper Awl placement
The marks on the Pedicle 
Probe will help determine 
the appropriate screw 
lengths (35, 40, 45, 50,  
or 55 mm).
OPTIONAL:   
Depth Sleeve
If you have difficulty 
seeing the marks on 
the tip of the Pedicle 
Probe, use the Depth 
Sleeve and the 
corresponding marks 
on the proximal end of  
the shaft.

8
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
OPTIMA ZS Screw
Pedicle Preparation
Using the OPTIMA ZS Awl and Probe, 
prepare the pedicles of the vertebrae 
below the Dynesys screw for 
insertion of the OPTIMA ZS transition 
screw and OPTIMA ZS screw(s).
Screw insertion should follow the 
angle of the pedicle canal. 


Correct lateral placement  
of all the screws
Dynesys Screw Placement
Place Dynesys screws as described in 
the following sections of the Dynesys 
LIS Surgical Technique Manual, 
L1301:
• Pedicle Screws
• Set Up of the Guide Pin and Pedicle 
Screw
• Placement of the Guide Pins and 
Pedicle Screws
Proper lateral screw 
placement
<10 mm

9
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Use of Guide Pins
OPTIMA ZS Transition 
Screw Placement
The OPTIMA ZS transition screw is 
placed lateral to the facet joint (see 
Pedicle Screw Preparation). 
Select the appropriate size OPTIMA ZS 
transition screw. 
Using the OPTIMA ZS Small Poly  
Screw Driver, insert the OPTIMA ZS  
transition screw. 
Note: Insert the OPTIMA ZS transition screw as 
deep as possible.
Insert the OPTIMA ZS transition screw 
into the desired pedicle. 
Note: Ensure that the Driver is fully  
engaged with the screw prior to inserting. The 
tip of the screw will not toggle when  
the driver is fully engaged. 
Caution: While implanting the  
OPTIMA ZS transition screw, do not 
damage the facet joint capsule. 
Note: In order to facilitate the assembly  
of the screws, the optional Dynesys Guide Pin 
can be removed. 
Straight or Curved 
Testers are graduated 
to help determine 
hole depth
Guide Pins may be placed to identify 
the appropriate screw trajectory 
(OPTIMA ZS screws and OPTIMA ZS 
transition screw only) via a lateral 
X-Ray view.
Check the integrity of the pedicle wall 
with the OPTIMA ZS Tester.

10
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
OPTIMA ZS Screw Placement
Place the OPTIMA ZS screws as 
described in the following sections 
of the OPTIMA ZS Surgical Technique, 
L1264:
• Pedicle Preparation
• Polyaxial Screw Insertion
Note: Select only OPTIMA ZS polyaxial screws 
for a proper alignment with the OPTIMA ZS 
transition polyaxial screw.
Note: Check that the standard OPTIMA ZS 
screw is placed lateral to the facet joint like the 
cranial Dynesys screws.
Repeat the same procedure for all 
pedicle screws on the contra-lateral 
side.
DTO Implant Selection
Once screws have been placed, 
determine the appropriate rod  
length of the DTO implant. 
The rod should extend approximately  
5 mm beyond the most distal edge  
of the inferior screw polybody.
Dynesys 
Pedicle screw
OPTIMA ZS 
Transition 
screw
OPTIMA ZS  
screw
Pin to be  
pressed
Small needle
Protective bag

11
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
DTO Implant –  
Final Preparation  
Before Insertion
Caution: Use new gloves when  
handling the DTO implant and  
Hand Press. 
Carefully remove the DTO implant  
from its sterile packaging (Refer to 
Appendix 2).
The DTO implant is delivered partially 
pre-assembled. A small needle 
ensures that the cord maintains its 
position in the rod. 
Caution: The DTO implant cord must  
be handled carefully during assembly to 
maintain aseptic conditions.  
It is delivered in a protective bag  
to maintain aseptic conditions prior  
to assembly.
In order to complete the assembly 
of the implant, the pin must be 
fully pressed using the Hand Press. 
Final insertion ensures sufficient 
connection strength between the 
cord and the rod. 
Keep the cord in its protective bag  
during handling. 
Caution: Do not implant the DTO without 
fully pressing the pin.
Open the Hand Press.
Note: The Blue handle is placed on the top. 
Note: Refer to Appendix 1 for more information 
regarding the Hand Press.

12
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Place the DTO implant into the Hand 
Press and position according to the 
‘cord’ and ‘rod’ markings on the 
instrument.
Once the DTO implant is correctly 
placed in the Hand Press, close the 
Hand Press.
Note: The Hand Press can only be closed in 
one direction.
Ensure the Power Screw is at its 
highest position prior to closing the 
Hand Press. The Hand Press cannot 
be closed if the Power Screw is 
partially advanced.
Caution: Do not use excessive force to 
close the instrument; otherwise, it may 
be damaged.

13
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Turn the handle of the Hand Press  
in a clockwise direction until there  
is no further rotation. 
Ensure the line on the ram is past the 
line on the Hand Press body.
Start Position
End Position

Ram

14
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Release the Power Screw by turning  
the handle counterclockwise until  
the Hand Press opens.
Carefully remove the DTO implant  
from the Hand Press.
Note: Hold the cord by its protective bag 
to ensure aseptic handling.
Caution: Visually check that the pin  
has been fully inserted/pressed into the 
DTO implant prior to implantation.
Check that the pin surface is flush  
with the DTO implant.
If the pin is not fully inserted, repeat  
the preparation with the Hand Press.
Caution: Remove the protective bag 
before continuing the assembly. 



15
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
DTO Implant Assembly
The DTO rod is delivered pre-bent.
Caution: Rod is supplied pre-bent and 
must not be further contoured.
First place the connecting part of 
the DTO implant into the OPTIMA ZS 
transition screw. 
Caution: The OPTIMA ZS Persuader 
cannot be used with the OPTIMA ZS 
transition screw.
In the cranio-caudal direction, 
placement of the DTO implant is  
guided by the two flanges on each  
side of the connecting part. 
Caution: Carefully handle the cord  
during the assembly in order to ensure 
aseptic conditions.
Caution: The surface containing the  
pin of the connecting part must be facing 
upwards from the exposure. 
The DTO rod is placed in the OPTIMA 
ZS screw head using the Rod Holder. 
The Rod Pusher may be used to 
seat the DTO rod while inserting set 
screws with the Set Screw Inserter.

16
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Note: Use a set screw from the OPTIMA ZS Set 
for the OPTIMA ZS transition screw. 
Caution: Only use a small set screw  
for the OPTIMA ZS transition screw. 
Insert the set screw of the OPTIMA ZS 
transition screw using the OPTIMA ZS 
Set Screw Driver Guide. 
Note: The DTO implant must be adequately 
seated prior to set screw insertion. 
The set screw starts easily when 
properly aligned. If incorrectly 
aligned, the set screw will exhibit 
noticeable resistance during the 
initial threading. If this occurs, back 
the set screw completely off the 
screw and check that it is properly 
seated on the Set Screw Driver 
Guide. 
Advance the set screw as far as 
possible, but: 
• Do not attempt to final tighten 
	 the system using the Set Screw 
 Driver Guide. 
• 	Over-tightening of the set screw  
	 could damage the OPTIMA ZS  
	 transition screw thread.
Repeat the same procedure for the 
OPTIMA ZS screws. 
Small Set Screw
Large Set Screw



17
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Caution: Select the appropriate set screw 
for the OPTIMA ZS screw. Two set screws 
are available.
Select and place the DTO implant  
for the contra-lateral side. 
Insert the set screws. 
Compression / Distraction
Provisionally tighten the set screw 
on the side of the segment being 
translated, while leaving the set 
screw on the contra-lateral side 
loose.
Perform compression or distraction 
against the provisionally tightened 
assembly. 
In case of a compression, a special  
DTO Compressor with Protective 
Adapters has been designed to  
protect the polished surface of the  
DTO implant. 
Caution: Only use the DTO Compressor 
for compression.
Caution: Excessive compression force 
can result in damage of anatomical 
structures or compromise the implant/
bone interface. 
Caution: Do not use any Compressor  
on the Dynesys screw.
Caution: Complete any compression/
distraction before the implanting of the 
Dynesys spacer. 
• 	5.0 mm, 6.0 mm and  
7.0 mm polyaxial screws 
utilize the Small Set Screw
• 	7.5 mm and 8.0 mm 
polyaxial screws utilize the 
Large Set Screw
Small Set Screw
Large Set Screw

18
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Final Set Screw Tightening
After achieving the desired amount  
of correction, perform final tightening 
of the set screw.
Place the DTO Anti-Torque on the 
OPTIMA ZS transition screw and use  
the OPTIMA ZS Axial Torque Wrench  
to tighten the set screw(s).
Caution: The DTO Anti-Torque is intended 
for use on the OPTIMA ZS transition 
screw only.
Tighten the set screw until the line 
and arrow on the Torque Wrench 
Handle (106 in-lbs./12 Nm) align. 
Initial torque
position
Final torque position
(106 in-lbs.)

19
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Position the OPTIMA ZS Anti-Torque  
over the polybody of the OPTIMA ZS 
screws to be tightened.
Insert the Axial Torque Wrench  
through the cannulated Anti-Torque 
Device into the set screw.
Tighten the set screw until the line 
and arrow on the Torque Wrench 
Handle (106 in-lbs./12 Nm) align.
Repeat the process until the 
remaining set screws are tightened.
Alternative Technique for OPTIMA  
ZS Screws:
Assemble the 4 mm OPTIMA ZS Hex 
Driver and the Torque Limiting 
T-handle.
Insert the 4 mm Hex Driver through  
the cannulated Anti-Torque into the 
OPTIMA ZS set screw.
Caution: Only use this optional 
instrument with the OPTIMA ZS  
screws and not with the OPTIMA ZS  
transition screw.

20
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Tighten the set screw until the Torque 
Limiting T-handle breaks over/clicks  
at 106 in-lbs./12 Nm.
Note: The Axial Torque Wrench or 4 mm  
Hex Driver and Torque Limiting T-Handle  
used in conjunction with the Anti-Torque  
are the only instruments acceptable for  
final set screw tightening.
Caution: Do not place the transverse link 
against the connecting part of the DTO 
implant.
Optional: Transverse links may be  
used to connect rod segments.
For more information, please review 
the OPTIMA ZS Spinal System surgical 
technique.
Adjustable transverse links 
are color-coded according  
to length. 

21
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Top View of Pedicle Distance 
Gauge
1
2
4
5
3
1. Start Position
2. Drag Indicator for length  
of Universal Spacer
3. Distraction Indicator
4. Ball end
5. Forked end
Dynesys Assembly 
Re-insert the optional Dynesys Guide 
Pins on the Dynesys screws heads to 
assist in docking instrumentation.
Using the Dynesys Pedicle Distance 
Gauge with a forked edge, measure 
the spacer length between the 
Dynesys pedicle screw and the 
OPTIMA ZS transition screw.
Verify that the Drag Indicator is in the 
start position.
Assess the movement in the facets 
in distraction and compression. 
Measure the distance (spacer length) 
with a slight distraction force. 
Note: The Pedicle Distance Gauge with  
a forked end must be used, and is included in 
the DTO instrument tray.
Caution: Do not induce kyphosis  
or scoliosis.
Record the measured spacer length 
for the levels.
Cut the Dynesys spacer with the 
Dynesys Spacer Cutter according 
to the previously determined 
measurement.
Thread the appropriately sized spacer 
onto the DTO cord and place against 
the OPTIMA ZS transition screw head.
Using a clamp, insert the DTO  
cord through the Dynesys pedicle  
screw head.
Note: The end of the introduction zone of the 
cord can be bent to facilitate the introduction 
of the cord into the screw head.
Note: Avoid twisting and looping of the cord.

22
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Complete the Dynesys construct 
assembly and cord tensioning 
according to the Dynesys LIS Surgical 
Technique, L1301:
• Construct Assembly

23
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Final Construct
After segment by segment work,  
a two-level assembly is completed.
Decorticate the posterior elements 
as necessary. Place bone graft to 
achieve the desired fusion.

24
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Hardware Removal/
Revision Instructions
Set Screw Removal 
Position the appropriate Anti-Torque 
Device over the pedicle screw body 
of the set screw to be removed. 
Insert the matching Torque Wrench 
through the Anti-Torque Device and 
into the set screw. Turn the Torque 
Wrench counterclockwise until the 
set screw is loose but not completely 
disengaged. Remove the Torque 
Wrench and Anti-Torque Device. 
Carefully remove the OPTIMA ZS set 
screws with the Set Screw Driver 
Guide and the Dynesys set screws 
with the Set Screw Starter. Repeat for 
all set screws.	
	
	
	
	  
DTO Implant Removal
Place the OPTIMA ZS Rod Holder 
onto the rod component of the DTO 
implant near the connecting portion 
and remove from the OPTIMA ZS 
pedicle and transition screws. Once 
the DTO Implant connecting portion 
has been removed from the OPTIMA 
ZS transition screw, carefully remove 
the DTO cord and Dynesys spacer 
assembly. It may be necessary to cut 
the cord adjacent to the spacer with 
a scalpel blade to facilitate removal. 
Remove all components of the DTO 
implant. Repeat on the contralateral 
side.
OPTIMA ZS Transition and Pedicle Screw 
Removal 
Insert the tip of the OPTIMA ZS Small 
Poly Screw Driver into the polybody, 
positioning the tangs of the attached 
T-Handled Screwdriver Sleeve into 
the slots on the screw body. Turn 
the Ratchet handle clockwise while 
holding the Screwdriver Sleeve. Once 
the pedicle screw is fully engaged 
on the driver, carefully turn the 
screwdriver counterclockwise until 
the OPTIMA ZS screw is removed. 
Repeat for all OPTIMA ZS transition 
and pedicle screws. 
Dynesys Pedicle Screw Removal 
Insert the Long Retainer into the 
Pedicle Screw Driver handle and 
turn clockwise to engage. Place 
the Pedicle Screw Driver onto the 
Dynesys screw head using the marks 
located on the Pedicle Screw Driver 
to ensure proper orientation. Turn the 
Long Retainer clockwise and secure 
the Dynesys screw to the Pedicle 
Screw Driver. 
Caution: Do not overtighten the Long 
Retainer. 
Once the pedicle screw is fully 
engaged on the driver, carefully turn 
the Screw Driver counterclockwise 
until the Dynesys screw is removed. 
Repeat for all Dynesys pedicle 
screws.   
Carefully examine the operative site 
to ensure all hardware has been 
removed.

25
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Postoperative Treatment
It is the responsibility of the surgeon 
to assess the adequate postoperative 
treatment depending on the patient’s 
condition.
Analgesics
Possible antibiotic prophylaxis 
against infection
Possible prophylaxis against 
thromboembolism
Early physiotherapy
Limited activity is recommended for 
approximately six weeks
A non-rigid brace should be 
considered during the period of 
limited activity
A gradual resumption of activities 
can begin after approximately 6 
weeks
Cleaning Instructions
For information on cleaning and 
sterilization refer to:
•	OPTIMA ZS Instruction for Use 
leaflet, IFU-SD01
•	Dynesys and DTO Instructions for 
	 Use leaflet, D011500217
	 Caution: Pedicle screws should not be 
put back in the tray for resterilization if 
they have been in contact with bodily 
fluids. They should be treated as a 
biohazard and disposed of accordingly.
Please consult the following 
documents for additional information 
on the instrumentation:
• Dynesys LIS Instruments 
	 Instructions for Use
	 07.00996.001
• Zimmer DTO Instruments Cleaning 	
	 Leaflet, 07.01352.001
• Instructions for Use for Surgical 
	 Instruments, D011500192
	 Warning: Do not sterilize the OPTIMA 
ZS transition screw tray with the 
Zimmer DTO instrument tray. The 
effectiveness of the sterilization of 
these two trays together has not been 
established. Refer to the sterilization 
instructions for each system in their 
respective Instructions for Use leaflets.

26
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Appendix 1
The Hand-Press 
Handle (top)
Power Screw Housing
Ball and Spring Plunger
Power Screw
Ram
Implant Housing
Handle (bottom)
Hinge Screw

27
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Appendix 2
Aseptic handling of the  
DTO Implant 
Remove the DTO implant from its 
innermost pouch but leave the cord  
in its protective bag to allow aseptic 
handling of the implant during  
the assembly. 
Caution: The protective bag must be  
removed before the final assembly  
of the implant inside the patient.

28
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
OPTIMA™ ZS Spinal System & OPTIMA™ ZS Transition 
Screw
Instructions for Use
Precaution:
The implantation of pedicle screw spinal systems should 
be performed only by experienced spinal surgeons with 
specific training in the use of this pedicle screw spinal 
system because this is a technically demanding procedure 
presenting a risk of serious injury to the patient.
Warning:
The safety and effectiveness of pedicle screw spinal 
systems have been established only for spinal condi-
tions with significant mechanical instability or deformity 
requiring fusion with instrumentation. These conditions 
are significant mechanical instability or deformity of the 
thoracic, lumbar and sacral spine secondary to degenera-
tive spondylolisthesis with objective evidence of neurologic 
impairment, fracture, dislocation, scoliosis, kyphosis, 
spinal tumor, and failed previous fusion, (pseudoarthrosis). 
The safety and effectiveness of these devices for any other 
condition is unknown. The safety and effectiveness of this 
device for the indication of spinal stabilization without 
fusion have not been established.
Important Note:
The users of the OPTIMA™ ZS Spinal System acknowledge 
that they have read and agreed to the conditions in this 
insert, which are considered to be contractual. When using 
the Zimmer GmbH Zimmer® DTO™ Implant, the users of 
the OPTIMA™ ZS Spinal System should also study carefully 
Instruction for Use and Surgical Technique Manual of the 
Zimmer GmbH Dynesys® Spinal System as well as the 
product-specific information. In addition, it should be 
noted that the Dynesys® Spinal System and the Zimmer® 
DTO™ Implant are only indicated for use in the posterior 
lumbar spine. For additional details regarding the indica-
tions for use, precautions, warnings, contraindications and 
other product specific information for the Dynesys® Spinal 
System and the Zimmer® DTO™ Implant refer to the Instruc-
tions for Use for these devices.
Basic Structure:
The OPTIMA™ ZS Spinal System is an internal fixation device 
for spinal surgery comprising pedicle screws, connectors, 
rods, housings and transverse link assemblies. Various 
forms and sizes of these implants are available, so that 
adaptations can be made to take into account the pathol-
ogy and individual patient.
Material:
All components of the OPTIMA™ ZS Spinal System and the 
OPTIMA™ ZS Transition Screw are made of Ti6Al4V ELI, a 
titanium-based alloy which complies with ASTM F136.
Indications for Use:
The OPTIMA™ ZS Spinal System is a posterior pedicle 
screw fixation system indicated for the treatment of severe 
spondylolisthesis, (Grade 3 and 4), of the L5-S1 vertebra in 
skeletally-mature patients receiving fusion by autogenous 
bone graft having implants attached to the lumbar and 
sacral spine with removal of implants after the attainment 
of a solid fusion.
In addition, The OPTIMA™ ZS Spinal System is intended 
to provide immobilization and stabilization of spinal 
segments in skeletally-mature patients as an adjunct to 
fusion in the treatment of the following acute and chronic 
instabilities or deformities of the thoracic, lumbar and 
sacral spine:
• Degenerative spondylolisthesis with objective evidence of 
neurological impairment
• Fracture of the vertebral body
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (Pseudoarthrosis).
When the Zimmer GmbH Dynesys® Spinal System and the 
OPTIMA™ ZS Spinal System are used on contiguous levels, 
they must be used with the Zimmer GmbH Zimmer® DTO™ 
Implant, rod-cord combination implant, and the OPTIMA™ 
ZS Transition Screw. The indications for use for each level is 
as specified for each system.
Note: The OPTIMA™ ZS Spinal System’s Surgical Technique 
Manual should be followed carefully. Important informa-
tion on the proper usage of implants and instruments is 
included. When using the Zimmer® DTO™ Implant, the users 
of the OPTIMA™ ZS Spinal System should also study care-
fully Instruction for Use and Surgical Technique Manual of 
the Dynesys® Spinal System as well as the product-specific 
information.
Levels of Fixation:
Levels of fixation are for the thoracic, lumbar and sacral 
spine.
General Conditions of Use:
• The implants must be implanted only by surgeons having 
undergone the necessary training in spinal surgery. Their 
use in implantation must be decided upon in accordance 
with surgical and medical indications, the potential risks 
and limitations related to this type of surgery, the con-
traindications, side effects and precautions. The surgeon 
should also possess knowledge of the metallurgic and 
biological characteristics of the implants.
• The OPTIMA™ ZS Spinal System implants and implants 
parts should never be combined with parts from other 
companies, unless otherwise indicated in the Instruction 
for Use and/or Surgical Technique Manual. General use 
operating room instruments and/or other instruments 
described in the surgical technique are permitted for 
use. In addition, when using the Zimmer GmbH Zimmer® 
DTO™ Implant it is permitted to combine the Zimmer 
GmbH Dynesys® Spinal System with the OPTIMA™ ZS 
Spinal System. Each system must be implanted using 
the appropriate instruments and surgical technique as 
defined in the respective Surgical Technique Manuals. 
The instruments for the different systems must not be 
commingled or used interchangeably. If this should occur, 
U&i Corporation declines all responsibility.
• Under no circumstances may the implants be re-used 
after previous implantation or patient contact. Although 
the device may appear intact on removal, internal 
modification due to the stress and strains placed on it, 
or small defects may exist which may lead to fracture of 
the implant.
Contraindications:
• Any active or suspected latent infection in or about the 
spine.
• Any mental or neuromuscular disorder which would create 
an unacceptable risk of fixation failure or complications 
in post-operative care.
• Bone stock compromised by disease, infection or prior 
implantation which cannot provide adequate support and 
or fixation to the implant.
• Obesity, an overweight or obese patient can produce 
loads on the spinal system which can lead to failure of 
the fixation of the device or to failure of the device itself.
• Recent infection, fever or leukocytosis
• Bony abnormalities preventing safe screw fixation
• Open wounds
• Metal sensitivity, documented or suspected
• Bone absorption, osteopenia and/or osteoporosis
• Patients having inadequate tissue coverage over the 
operative site
• Pregnancy
• Excessive local inflammation
• Use in the cervical spine
• Alcohol or drug abuse
• Patient unwilling or unable to follow postoperative 
instructions
• Sensitivities/allergy to polymers, polyethylene, polycar-
bonate, urethane and polyethylene terephthalate when 
using the Zimmer GmbH Dynesys® Spinal System and the 
Zimmer® DTO™ Implant
• Other medical or surgical conditions which would pre-
clude the potential benefit of spinal implant surgery such 
as the presence of tumors, congenital abnormalities, 
elevation of sedimentation rate unexplained by other 
diseases, elevation of white blood cell count, (WBC) or 
marked left shift in the WBC differential count.
Side Effects:
• Late bone grafting or no visible fusion mass and pseud-
arthrosis
• Neurological complication, paralysis, soft tissue lesions, 
pain, wound complication, paresthesia and cerebral spi-
nal fluid leakage due to the surgical procedure, breakage 
deformation and or migration of the implant
• Pedicle failure while preparing and inserting the pedicle 
screw
• Superficial or deep-set infection and inflammatory 
phenomena
• Allergic reaction to the implant material
• Reduction in bone density due to different distribution of 
mechanical stresses
• Pain and abnormal sensations due to hardware bulkiness
• Neurological and spinal dura matter lesions from surgical 
trauma
• Bursitis
• Presence of micro-particles around the implants
• Growth of the fused vertebrae is altered
• Partial loss of the degree of correction achieved during 
surgery
• Modification of spinal curvature and stiffness of the 
vertebral column
• Loosening, disassembly, bending or breakage of 
components
• Non-union or delayed union
• Fracture of vertebrae
• Foreign body reaction (allergic) to components or debris
• Loss of fixation
• Vascular or visceral injury
• Gastrointestinal, urological and/or reproductive system 
compromise
• Loss of bone or fracture of bone above or below the level 
of surgery
• Bone graft donor site pain, fracture, and/or delayed 
wound healing
• Restriction of activities
• Lack of effective treatment of symptoms for which surgery 
was intended
• Death
• The above list of side effects is not exhaustive. These 
side effects can sometimes necessitate further surgical 
treatment.

29
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Precautions:
• The surgeon should consider the level of implantation, 
the weight of the patient, the patient’s activity level or 
general conditions and any other factor which may have 
an impact on the performance of the system based on 
published fatigue test results of the system.
• Patients who smoke have been shown to have an 
increased incidence of non-unions. Such patients should 
be advised of this fact and warned of the potential 
consequences.
• If the patient is involved in an occupation or activity which 
applies inordinate stress upon the implant (e.g., substan-
tial walking, running, lifting or muscle strain), resultant 
forces can cause failure of the device.
• In some cases, progression of degenerative disease may 
also be so advanced at the time of implantation that 
they may substantially decrease the expected useful life 
to the appliance. In such cases, orthopedic devices may 
be considered only as a delaying technique or to provide 
temporary relief.
• Before clinical use, the surgeon should thoroughly 
understand all aspects of the surgical procedure and 
limitations of the spinal fixation system. This device is 
recommended for use only by surgeons familiar with pre-
operative and surgical techniques, cautions and potential 
risks associated with such spinal surgery. Knowledge 
of surgical techniques, proper reduction, selection and 
placement of implants, and pre and post-operative 
patient management are considerations essential to a 
successful surgical outcome.
• Patients should be instructed in detail about the limita-
tions of the implants, including but not limited to the 
impact of excessive loading through patient weight or 
activity, and should be taught to govern their activities ac-
cordingly. The patient should understand that a metallic 
implant is not as strong as normal, healthy bone and will 
bend, loosen or fracture if excessive demands are placed 
on it. An active, debilitated or demented patient who 
cannot properly use weight supporting devices may be 
particularly at risk during postoperative rehabilitation.
• Appropriate selection, placement and fixation of the 
spinal system components are critical factors which 
affect implant service life. As in the case of all prosthetic 
implants, the durability of these components is affected 
by numerous biologic, biomechanics and other extrinsic 
factors, which limit service life. Accordingly, strict adher-
ence to the indications, contraindications, precautions, 
and warnings for this product is essential to potentially 
maximize service life. (Note: While proper implant selec-
tion can minimize risks, the size and shape of human 
bones present limitations on the size, shape and strength 
of the implants.)
• Care must be taken to protect the components from being 
marred, nicked or notched as a result of contact with 
metal or abrasive objects. Alterations will produce defects 
in surface finish and internal stresses which may become 
the focal point for eventual breakage of the implant. 
Warning:
• The safety and effectiveness of this device for the 
indication of spinal stabilization without fusion have 
not been established.
• The benefit of spinal fusion utilizing any pedicle screw 
fixation system has not been adequately established in 
patients with stable spine.
• Potential risks associated with the use of this system, 
which may require additional surgery, include device 
component fracture, loss of fixation, non-union, fracture 
of the vertebra, neurological injury and vascular or 
visceral injury.
• Discard all damaged or mishandled implants.
• Never reuse an implant after patient contact even though 
it may appear undamaged.
• Internal fixation devices cannot withstand activity and 
loads equal to those placed on normal healthy bone. 
Until maturation of the fusion mass is confirmed, do not 
subject this device to the stress of full weight bearing, or 
implant failure may result.
• Contouring or bending of a screw or hook may reduce its 
fatigue strength and cause failure under load. If spinal 
screws or hooks are bent or otherwise damaged during 
insertion or adjustment, they may not be implanted and 
must be replaced. Rods should only be contoured with 
the proper contouring instruments. Incorrectly contoured 
rods or rods which have been repeatedly or excessively 
contoured must not be implanted.
• The Zimmer GmbH Zimmer® DTO™ Implant rods are sup-
plied pre-bent and should not be further contoured.
• Mixing Metal: Some degree of corrosion occurs on all 
implanted metal and alloys. Contact of dissimilar metals, 
however, may accelerate this corrosion process. The 
presence of corrosion may accelerate fatigue fracture of 
implants and the amount of metal compounds released 
into the body system may also increase. Internal fixation 
devices such as rods, connectors, screws, hooks, etc., 
which come into contact with other metal objects must be 
made from like or compatible metals.
• Removal of an unloosened spinal screw may require the 
use of special instruments to disrupt the interface at the 
implant surface. This technique may require practice in 
the laboratory before being attempted clinically.
• Any decision by a surgeon to remove the internal fixation 
device should take into consideration such factors as the 
risk to the patient of the additional surgical procedure as 
well as the difficulty of removal.
• Implant removal should be followed by adequate postop-
erative management to avoid fracture.
Packaging, Labeling and Storage:
• Individual OPTIMA™ ZS Spinal System implants are 
delivered in packages. These must be intact at the time of 
receipt. All the legal information required for this type of 
implant is given in the labeling of each package.
• Implants may also be delivered as a complete set, in 
specially designed trays or in boxes which can be steril-
ized directly.
• Use care in handling and storage of implant components. 
Cutting, sharply bending or scratching the surface can 
significantly reduce the strength and fatigue resistance 
of the implant system. This, in turn, could induce cracks 
and/or non-visible internal stresses that could lead to 
fracture of the implants. Implants and instruments in 
storage should be protected from corrosive environments 
such as air, moisture, etc. Inspection and trial assembly 
are recommended prior to surgery to determine if the 
instruments or implants have been damaged during 
storage or prior procedures.
Sterilization Procedures:
The OPTIMA™ ZS implants are provided clean and non-
sterile, and must be sterilized prior to use using one of the 
following recommended sterilization cycles.
• CAUTION: Use of sodium hydroxide (NaOH) is prohibited. 
Use of corrosive products and/or instruments including 
abrasive sponges and metal brushes should be avoided.
• Implant removed from a patient or that contact bodily 
tissues or fluids should never be reused.
• Sterilization: Recommended method to achieve a degree 
of sterility equal to at least 10-6. Sterilize by the autoclav-
ing procedure regularly used in the hospital.
°	Suggested method (1): Steam, Wrapped Gravity Cycle at 
132° C (270° F) for 20 minutes.
°	Suggested method (2): Steam, Prevacuum Cycle at 132° 
C (270° F) for 4 minutes.
Warning:
The Zimmer GmbH Dynesys® Spinal System Implants and 
the Zimmer® DTO™ Implants are delivered sterile and 
cannot be re-sterilized. Do not sterilize the OPTIMA™ ZS 
Transition Screw tray inside the Zimmer® DTO™ Instrument 
Tray. The effectiveness of the sterilization of these two trays 
together has not been established.

30
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Dynesys® Spinal System and the Zimmer® DTO™ Implant 
Instructions for Use
1.0 Description
When used as a pedicle screw fixation system, the Dynesys 
Spinal System is intended to provide immobilization 
and stabilization of spinal segments as an adjunct to 
fusion in the treatment of the following acute and chronic 
instabilities or deformities of the thoracic, lumbar, and 
sacral spine: degenerative spondylolisthesis with objective 
evidence of neurologic impairment, and failed previous 
fusion (pseudoarthrosis).  The Dynesys Spinal System is 
comprised of a variety of pedicle screws sizes, tensioning 
cords and longitudinal spacers that are uniquely fitted for 
each individual case. The pedicle screws are manufactured 
from medical grade titanium alloy conforming to ISO 
5832-11. They are provided with or without hydroxyapatite 
coating conforming to ISO 13779-2. The tensioning cords 
are manufactured from Sulene-PET (polyethylene-tere-
phthalate). The longitudinal spacers are manufactured from 
Sulene-PCU (polycarbonate-urethane).
The Zimmer DTO Implant is a cord-rod combination implant 
that is assembled intraoperatively by the final tightening 
of the fastening pin. The U & I Corporation Optima™  ZS 
Transition Screw is a transition pedicle screw that is part 
of the Optima ZS Spinal System. The Zimmer DTO Implant 
is used as an interface device when the Dynesys Spinal 
System and the Optima ZS Spinal System are implanted 
at adjacent levels. The tensioning cords are manufactured 
from Sulene-PET. The rod and pin are manufactured from 
Ti-6Al-4V conforming to IS0 5832-3. For information on 
the intended use, device description and materials for the 
Optima ZS Spinal System and the Optima ZS Transition 
Screw refer to the U & I Corporation’s Instructions for Use 
for the Optima ZS Spinal System.
Before using the Dynesys Spinal System alone or in 
combination with the Zimmer DTO Implant the operating 
surgeon should study carefully the following recom-
mendations, warnings and instructions, as well as the 
product-specific information. 
Any complications or other effects that may occur for rea-
sons such as incorrect indications or surgical technique, 
unsuitable choice of material or treatment, inappropriate 
use or handling of the instruments, sepsis, etc., fall 
within the responsibility of the operating surgeon; the 
manufacturer, the importers or the suppliers of Zimmer 
products cannot be held liable for same.
Zimmer products should be implanted only by operating 
surgeons who are familiar with the general problems of 
spinal surgery and who are able to master the product-spe-
cific surgical technique.
Implants are always components of a system. They should 
only be combined with other components belonging to the 
same system or as defined in the surgical technique, and 
may be implanted only using original instruments also 
belonging to the same system unless otherwise indicated.
•	 Occasional exceptions to the above rules are pointed 
out in the description of the surgical technique or in the 
product description.
•	 Zimmer Companies implants and implant parts should 
never be combined with parts from other companies, un-
less otherwise indicated in the Instructions for Use and/or 
the Surgical Technique Manual. General use operating 
room instruments and/or other instruments described in 
the surgical technique are permitted for use. In addition, 
when using the Zimmer DTO Implant it is permitted to 
combine the Dynesys Spinal System with the Optima ZS 
Spinal System. Each system must be implanted using the 
appropriate instruments and surgical technique as defined 
in the respective Surgical Technique Manuals. The instru-
ments for the different systems must not be commingled or 
used interchangeably.
•	 Spinal implants must not be machined or altered in any 
way, unless instructed to do so in the surgical technique.
•	 Implants or implant-parts that are contaminated, not 
sterile, damaged, scratched or have been improperly 
handled or altered without authorization may not be 
implanted under any circumstances.
2.0 Indications, Contraindications and Potential Adverse 
Events.
•	 An implant should only be considered if all other thera-
peutic possibilities have been carefully considered and 
found unsuitable or inappropriate.
•	 Any implant is subject to unavoidable wear and aging. 
In the course of time, an implant initially implanted in a 
stable manner can loosen or its functionality can become 
impaired. Wear, aging, loosening and so on can lead to the 
need for re-operation.
•	 The selection of patients depends to a great extent on 
the age of the patient, his/her general state of health, the 
condition of the existing bone, previous operations and 
anticipated further surgery. Normally speaking, prosthetic 
replacements are only indicated for patients whose skel-
eton is fully developed.
•	 For the indications, contra-indications and potential 
adverse events of the Optima ZS Spinal System refer to the 
Instructions for Use for that system.
2.1 Indications 
When used as a pedicle screw fixation system in skeletally 
mature patients, the Dynesys Spinal System is intended 
to provide immobilization and stabilization of spinal 
segments as an adjunct to fusion in the treatment of the 
following acute and chronic instabilities or deformities 
of the thoracic, lumbar, and sacral spine:  degenerative 
spondylolisthesis with objective evidence of neurologic 
impairment, and failed previous fusion (pseudoarthrosis). 
In addition, when used as a pedicle screw fixation system, 
the Dynesys Spinal System is indicated for use in patients: 
•	 Who are receiving fusions with autogenous graft only;
•	 Who are having the device fixed or attached to the 
lumbar or sacral spine;
•	 Who are having the device removed after the develop-
ment of a solid fusion mass.
When the Dynesys Spinal System and the Optima ZS 
Spinal System are used on contiguous levels, they must be 
used with the Zimmer DTO Implant, rod-cord combination 
implant, and the U & I Corporation Optima ZS Transition 
Screw.  The intended use for each level is as specified for 
each system.
2.2 Contraindications
Contraindications of the Dynesys Spinal System and the 
Zimmer DTO Implant are similar to other commercially avail-
able posterior spinal fixation systems. Contraindications 
include but are not limited to the following:
•	 Use in the cervical spine;
•	 Active systemic or local infection;
•	 Obesity;
•	 Pregnancy;
•	 Mental illness;
•	 Severe osteoporosis or osteopenia;
•	 Sensitivities/allergy to metals, polymers, polyethylene, 
polycarbonate urethane and polyethylene terephthalate;
•	 Alcohol or drug abuse;
•	 Patient unwilling or unable to follow postoperative 
instructions;
•	 Soft tissue deficit not allowing sound closure;
•	 Any medical or physical condition that would preclude 
the potential benefit of spinal implant surgery;
•	 Congenital abnormalities, tumors or other conditions 
that would prevent secure component fixation that has the 
potential to decrease the useful life of the device;
•	 Any medical or mental condition which would exclude the 
patient at high risk from surgery of this severity;
•	 For pedicle screw cases, inadequate pedicles of the 
thoracic, lumbar, and sacral vertebrae.
2.3 Complications and Possible Adverse Events
Prior to surgery, patients should be made aware of the fol-
lowing possible adverse effects in addition to the potential 
for additional surgery to correct these effects:
•	 Loosening, disassembly, bending or breakage of compo-
nents;
•	 Tissue sensitivity to implant material;
•	 Potential for skin breakdown and/or wound complica-
tions;
•	 Non-union or delayed union;
•	 Infection;
•	 Nerve damage, including loss of neurologic function, 
dural tears, paralysis, paresthesia, and cerebral spinal 
fluid leakage;
•	 Fracture of vertebrae;
•	 Foreign body reaction (allergic) to components or debris;
•	 Loss of fixation;
•	 Vascular or visceral injury;
•	 Change of normal spinal curvature;
•	 Gastrointestinal, urological and/or reproductive system 
compromise;
•	 Pain or discomfort;
•	 Bursitis;
•	 Decrease in bone density due to stress shielding;
•	 Loss of bone or fracture of bone above or below the level 
of surgery;
•	 High removal torques may be encountered with the use 
of the hydroxyapatite coated screw;
•	 Bone graft donor site pain, fracture, and/or delayed 
wound healing;
•	 Restriction of activities;
•	 Lack of effective treatment of symptoms for which surgery 
was intended;
•	 Death.
3.0 Warnings
The safety and effectiveness of the Dynesys Spinal System 
and the Zimmer DTO Implant have not been established for 
spinal indications beyond those stated in the Indications 
section.
The safety and effectiveness of this device for the indica-
tion of spinal stabilization without fusion have not been 
established.
For a complete list of Warnings and Precautions for the Op-
tima ZS Spinal System, including the Optima ZS Transition 
Screw, refer to the Instructions for Use for that system.
3.1 Precautions
Only experienced spinal surgeons with specific training 
in the use of the Dynesys Spinal System, the Zimmer DTO 
Implant and the Optima ZS Spinal system should perform 
the implantation of these systems.  This is due to the tech-
nically demanding procedure presenting a risk of serious 
injury to the patient.  These systems should only be used 
with instrumentation specifically designed for each system. 
Refer to the respective surgical techniques to determine 
which instruments should be used for each step of the 
surgical procedure.

31
Zimmer® DTO™ Implant and OPTIMA™ ZS Transition Screw with LIS Instruments
Unless the Zimmer DTO Implant is being used, components 
of spinal fixation systems other than Zimmer Companies 
should not be used with the components of the Dynesys 
Spinal System. Only the Optima ZS Spinal System, 
including the Optima ZS Transition Screw, may be used in 
combination with the Zimmer DTO Implant.
No component of the Dynesys Spinal System and the 
Zimmer DTO Implant should be reused or re-sterilized.  
The Dynesys Spinal System and the Zimmer DTO Implant 
are intended to be used with bone graft, which is required 
to provide additional spinal support.  A successful result is 
not always achieved in every surgical case.
The patients should be made aware that a successful 
result, as defined by reduced pain, increased function and 
the establishment of solid fusion, is not always achieved 
in every surgical case.  Proper patient selection will greatly 
affect the results.  Patients who smoke have been shown to 
have an increased incidence of non-union.  These patients 
should be informed of this increased risk and counselled to 
discontinue tobacco use prior to and immediately after sur-
gery.  Obese, malnourished, and/or alcohol abuse patients 
are also poor candidates for spinal fusion.  Patients with 
poor muscle tone and bone quality, and/or nerve paralysis 
are also poor candidates for spinal fusion.  The use of 
autogenous bone graft has been shown to provide superior 
results compared to the use of allograft bone graft material.
In addition to the above specified warnings and precau-
tions, general surgical risks should be explained to the 
patient prior to surgery.
3.2 Preoperative
•	 Only patients that meet the criteria described in Indica-
tions section and that do not have any conditions included 
in the Contraindications section of this package insert 
should be selected for surgery.
•	 Implants of this system must be handled and stored to 
avoid damage.  Implants should be protected from damage 
including scratches, nicks and corrosive environments.
•	 The surgeon should be instructed on the proper use of 
instruments and implants.
•	 The doctor must explain the risks of a spinal implant to 
the patient, including the possible impact of the factors 
mentioned under Section 2.3 on the success of the opera-
tion and the possible side effects. The patient should also 
be informed as to what steps he/she can take in order to 
reduce the possible effects of these factors.
Note: The Dynesys Spinal System, the Zimmer DTO Implant 
and the Optima ZS Spinal System Surgical Technique Manu-
als should be followed carefully.  Important information on 
the proper usage of implants and instrument are included.
3.3 Intraoperative
•	 The surgeon must follow the instructions provided in the 
surgical technique manual for the Dynesys Spinal System, 
the Zimmer DTO Implant and / or the Optima ZS Spinal 
System. Extreme caution must be used around the spinal 
cord and nerve root, especially during insertion of screws.
•	 A correct choice of the implant is extremely important. 
The appropriate type and size of an implant for the 
individual patient must be selected, taking anatomical and 
biomechanical factors into account.
•	 Aseptic handling is to be observed during the implanta-
tion.  Implants removed from a patient should never be 
re-sterilized or reused.
•	 The Zimmer DTO Implant requires specific assembly; 
refer to the respective Surgical Technique Manual for the 
assembly instructions.  
•	 When using the Zimmer DTO Implant, surgeon must be 
cautious about verifying that no component of the implant 
has become loose in the packaging, if the Zimmer DTO 
Implant components have become loose in the packaging 
please return the implant to Zimmer.
•	 Verify that the Zimmer DTO Implant is fully assembled 
prior to implantation.
•	 Remove any protective devices prior to implantation (i.e. 
protective caps or bags).
•	 The Zimmer DTO is supplied pre-bent and must not be 
further contoured.
3.4 Postoperative
•	 Implant removal should be considered after fusion 
has occurred.  The risk and benefit of a second surgical 
procedure must be evaluated carefully.  The surgeon is 
expected to supply postoperative care and management 
instructions to the patient.  The patient should be advised 
that non-compliance with post-operative instructions could 
lead to poor results, including implant failure.
•	 The patient must be adequately instructed regarding the 
risks and limitations of this implant system.  Additional 
surgeries may be required if fusion does not occur and 
implant failure occurs.
•	 Patient must be instructed on the physical limitations 
that are required to avoid placing excessive stress on the 
implant causing implant failure or delays in recovery.
•	 The patient must be informed that the risks of multiple 
complications do exist.
•	 Components of this system are only intended to support 
the spine during the period required to achieve solid spinal 
fusion.
•	 Regular X-ray checks are recommended in order to detect 
any changes in the position of the implant and signs of 
loosening or breakage of components.
•	 The patient should be urged to inform his doctor im-
mediately of any unusual changes to the operated area.
•	 The patient must be told that implants can affect the 
results of computer tomography (CT) or magnetic resonance 
imaging (MRI) scans.
•	 An implant-bearer’s card should also be made out for the 
patient
4.0 Sterilization
The Dynesys Spinal System and the Zimmer DTO Implants 
are Gamma-sterilized. Before the implant is used, the 
expiration date for sterility, indicated in the bar code or on 
the package label must be noted and the protective pack-
ing and the sterile packing must be checked for damage. 
Implants are provided ready to use, therefore, cleaning is 
not required. Implants must not be re-cleaned, re-steril-
ized or industrially processed for re-use after the surgery. 
Re-sterilization of synthetic materials/components can 
cause deterioration of the material.
Refer to the Optima ZS Spinal System Instructions for Use 
for instructions on the cleaning and sterilization of the Op-
tima ZS Spinal System and the Optima ZS Transition Screw.
Warning:  Do not sterilize the Optima ZS Transition Screw 
tray with the Zimmer DTO Instrument Tray.  The effective-
ness of these two trays together has not been established.  
Refer their respective sterilization instructions.
5.0 Storage and Handling
•	 Implants must be stored in their original packaging, 
unopened.
•	 Before implants are removed from their packaging, the 
protective wrapping must be examined for possible dam-
age as this could jeopardize their sterility. If an expiration 
date for sterility of the product is indicated, this must 
be observed. If the packaging is damaged or the sterility 
expiration date has been reached, the implants must not 
be used and must be returned to the manufacturer.
•	 Protective caps or other protective devices must not be 
removed until immediately before use.
•	 Implants are extremely sensitive to damage. Even small 
scratches or marks left by impacts on the surfaces will 
cause excessive wear or breakage and can give rise to com-
plications. Extremely careful handling is therefore strongly 
recommended.
•	 Any additional instructions (e.g. adhesive instruction 
labels on the packaging) are to be followed.
Refer to the Optima ZS Spinal System Instructions for Use 
for instructions for proper storage and handling of the Op-
tima ZS Spinal System and the Optima ZS Transition Screw.

Contact your Zimmer Spine representative or visit us at www.zimmerspine.com
www.zimmerspine.com
L1385 Rev.C  (851S-1001-00)  ©2008 Zimmer Spine, Inc.
Distributed by:
Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis, MN  55439 
Telephone  952.832.5600
or 800.655.2614
Fax  952.832.5620
The OPTIMA ZS Spinal System and OPTIMA ZS Transition Screw are:	 U&i Corporation is:
Manufactured by U&i Corporation	
Represented in the EU by Obelis S.A
529-1, Yonghyun-dong, Euijungbu, Kyunggi-do, Korea, 480-050	
Av.de Tervuren 34, bte 44, B-1040 Brussels, Belgium
Telephone: +82.31.852.0102	
Telephone: +32.2.732.59.54
Fax: +82.31.852.0107	
Fax: +32.2.732.60.03
Email: information@youic.com	
Email: mail@obelis.net or
www.youic.com	
miguel@obelis.net
U&i Corporation is:
Represented in the USA by RCRI Inc.	
Principal Regulatory and Quality Advisor
Regulatory & Clinical Research Institute, Inc.	
5353 Wayzata Boulevard, Suite 505	
Minneapolis, MN  USA 55416-1334	
Telephone: (952) 746-8080, ext. 234
Fax (651) 466-0145
The Dynesys Spinal System and Zimmer DTO 
Implant are manufactured by:
Zimmer GmbH 
Sulzer Allee/ P.O. Box
CH-8404 Winterthur
Switzerland
Tel:  41 (0)52 262 60 70
Fax: 41 (0)52 262 01 39
Zimmer is the exclusive, worldwide distributor of OPTIMA™ ZS Spinal System (except in Belgium, Luxembourg, Turkey and South Korea).  Zimmer has 
the exclusive, worldwide distribution rights for the OPTIMA™ ZS Transition Screw.
OPTIMA™ is a trademark of the U&i Corporation, Korea. All other names, trademarks, service marks and logos referenced to within this brochure  
are the property of Zimmer GmbH and/or their respective subsidiaries.

CMU2010-10S 
28March2012 v4 
 
Page 1 of 5 
 
 
INFORMED CONSENT 
 
 
 
 
TITLE: 
CMU2010-10S:  Post Market Surveillance for the Dynesys® Spinal System, 
Assessing Safety and Fusion. 
 
 
SPONSOR:    
Zimmer Spine 
 
INVESTIGATOR:   
____________________, MD 
 
 
 
STUDY SUMMARY 
 
This is a research study. 
 
Your decision to participate in this study is voluntary. 
 
You will be in the study for at least two (2) years. 
 
You will have at least five (5) study visits. 
 
The care you receive in this study is standard medical care for patients who undergo spine 
surgery.   
 
Your medical insurance will be billed for any treatment you receive as part of the study and 
other standard medical care.   
 
If you agree to be in this study, your medical records will become part of this study.  They will 
be reviewed and may be copied by the sponsor (Zimmer Spine) of this study, government 
agencies or other groups associated with the study.   
 
If you decide to be in this study and later change your mind, you can leave the study at any 
time. 
 
 
INTRODUCTION 
You are being asked to participate in a research study because your physician has determined that you are a 
candidate for a posterior lateral fusion surgery with pedicle screw instrumentation.    
 
Dynesys is a pedicle screw system comprised of a variety of pedicle screw sizes, tensioning cords and 
longitudinal spacers that are uniquely fitted for each individual case.  This product is not experimental or 
investigational, and is approved for use by the U.S. Food and Drug Administration (FDA). Dynesys has been 
implanted in more than 40,000 patients worldwide and has been available in the United States since 2005. 
 
The purpose of this study is to look at complications related to receiving Dynesys with autograft (a piece of 
bone taken from your spine) as compared to other types of pedicle screw systems.  Additionally, this study 
looks at the device’s ability to cause the spine to fuse or joint together.   
 
There will be approximately 168 patients enrolled in this study at up to 12 sites in the United States. Your total 
study participation will last approximately 24 months after your surgery. 
 
 
STUDY PROCEDURES 
If you agree to participate in this study, your study doctor or his /her staff will ask you about your medical 

CMU2010-10S 
28March2012 v4 
 
 
Page 2 of 5 
 
history and will examine you before your surgery.  You will be asked to complete questionnaires that provide 
information about your health and medical history, back/leg pain affecting your everyday life and medication 
usage.  You will undergo up to 4 x-rays to document your current status. 
 
Your surgery will require an incision(s) to be made on your back.  You will undergo a posterior lateral fusion 
surgery with Dynesys®, that will be described in detail by your surgeon.   
 
After surgery, you will be evaluated by your study doctor and/or his/her staff at 6 months, 12 months and 24 
months, and annual visits until the study is closed. These visits are scheduled at the same time you would 
normally visit your physician for this type of surgery.   Your postoperative (after your surgery) evaluations will 
include an examination of your back, an evaluation of your pain and up to 4 x-rays of your spine.   
 
You will also be asked to complete questionnaires, which will take about 15 minutes, at each postoperative 
study visit.  These questionnaires ask about your satisfaction regarding your surgery and post surgery 
recovery, your physical and emotional health and daily activities.  This information will allow the surgeons and 
the sponsor (Zimmer Spine) to evaluate your overall health and the outcome of your treatment. 
 
If any of the devices under study are removed, they must be returned to Zimmer Spine for further analysis and 
product safety monitoring, which may modify or destroy the implant.  You will not be able to keep the removed 
devices.   
 
 
RISKS AND DISCOMFORTS 
As with all surgical procedures there are risks involved.  Below is a list of risks that you should be aware of: 
 
General surgical risks include but are not limited to: 
Bleeding which his hard to stop, blood clots causing additional body damage, stroke, heart attack, allergic 
reactions to items used during surgery, problems caused by sleep medication, infections or sickness caught 
during surgery, infections in or around the surgical wound, failure of the surgery to achieve anticipated results, 
the need for a second surgery due to complications with the original surgery and death. 
 
Spinal surgery risks: 
The inability of the spine surgery to relieve pain and/or increase your ability to do things, loss of large amounts 
of blood, problems going to the bathroom, problems with food movement through the digestive system, tearing 
of the protective lining around the spine.  Although rare, damage to the spinal cord causing possible paralysis, 
may also occur, as well as fractures of the spine, damage to areas of the spine close to the area already 
causing trouble, narrowing of the spinal canal, increase instability of the spine and organ damage.  Also rare, 
but possible, are problems specific to men include pain or swelling of the testes or prostate, inability to perform 
sexually and inability to ejaculate.    
 
Spinal surgery risks with pedicle screw system: 
The screws being put in the wrong place, the screws breaking in the spine, the screws moving after surgery, 
the screws becoming loose, the connections coming apart, sensitivity to the screws or other materials placed 
into the spine, the need for another surgery and failure of the system.   
 
 
BENEFITS OF THE STUDY 
The potential benefit to you from the procedure is relief of pain and improved function.  There are no additional 
benefits to you for being in this study.  Your participation in the study will help to capture information that may 
potentially benefit others deciding on the appropriate surgical treatment for their back pain.  

CMU2010-10S 
28March2012 v4 
 
 
Page 3 of 5 
 
 
 
ALTERNATIVE TREATMENTS 
You may choose not to participate in this study.  If you choose not to participate, you may still receive the 
same treatment with Dynesys, or your physician will discuss other spinal surgeries and conservative 
treatments (i.e.: physical therapy, epidural injections, and medication treatments) available to you. 
 
 
CONFIDENTIALITY 
If you agree to participate in this research, identifiable health information about you will be used and shared 
with others involved in this research.  For you to be in this research, we need your permission to collect and 
share this information.  Federal law protects your right to privacy concerning this information.  
 
When you sign at the end of this consent form, it means that you have read this section and authorize the use 
and/or sharing of your protected health information as explained below.  Your signature also means you have 
received a copy of the Privacy Notice from your doctor. 
 
Under the federal privacy law, individually identifiable health information is considered to be any information 
from your medical record, or obtained from this study, that can be associated with you, and relates to your 
past, present, or future physical or mental health or condition.  This is referred to as protected health 
information. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary of 
the results. You can search this Web site at any time. 
 
 
Why is it necessary to use/share your protected health information with others?   
The main reason to use and share your health information is to conduct the research as described in this 
consent form.  Your information may also be shared with people and organizations that make sure the 
research is being done correctly, and to report unexpected or bad side effects you may have. 
 
In addition, we may be required by law to release protected health information about you.  This may occur if a 
judge requires such release in a lawsuit, or if you tell us of your intent to harm yourself or others. 
 
What protected health information about you will be used or shared with others as part of this research? 
We may use and share the results of tests, questionnaires, and interviews.  We may also use and share 
information from your medical and research records.  We will only collect information that is needed for the 
research. 
 
Who will be authorized to use and/or share your protected health information? 
The researchers, their staff and the staff of _________________________ participating in the research will 
use your protected health information for this research study.  In addition, the 
_________________________Institutional Review Board (IRB), a committee responsible for protecting the 
rights of research subjects, and other staff who supervise the way the research is done may have access to 
your protected health information. 
 
The researchers and their staff will determine if your protected health information will be used or shared with 
others outside of _____________________________ for purposes directly related to the conduct of the 
research, such as the sponsor (Zimmer Spine) and your insurance company.  

CMU2010-10S 
28March2012 v4 
 
 
Page 4 of 5 
 
 
The study sponsor (Zimmer Spine) will receive the details of your surgery, such as date of admission, date of 
discharge, operative level, length of surgery, blood loss during surgery, complications (if any) and discharge 
medications and follow-up office visits.  Additionally, if the product is explanted, the study sponsor will review 
documentation relating to the explant of the device. 
 
With whom would the protected health information be shared? 
Your protected health information may be shared with: 
 
Federal agencies that supervise the way the research is conducted, such as: the Department of 
Health and Human Services’ Office for Human Research Protections and the Food and Drug 
Administration (FDA), or other governmental offices as required by law. 
 
Your insurance company. 
 
The sponsor (Zimmer Spine) and its representatives. 
 
All reasonable efforts will be used to protect the confidentiality of your protected health information.  However, 
not all individuals or groups have to comply with the Federal privacy law.  Therefore, once your protected 
health information is disclosed, the Federal privacy law may not protect it.   
 
For how long will your protected health information be used or shared with others? 
There is no scheduled date at which this information will be destroyed or no longer used.  This is because 
information that is collected for research purposes continues to be used and analyzed for many years and it is 
not possible to determine when this will be complete. 
 
Can you withdraw your authorization to collect/use/share your protected health information? 
You always have the right to withdraw your permission (revoke authorization) for use, by putting your request 
in writing to the study doctor.  This means that no further private health information will be collected.  Once 
authorization is revoked, you may no longer participate in this research activity, but standard medical care and 
any other benefits to which you are entitled will not be affected.  Revoking your authorization only affects use 
and sharing of information obtained after your written request has been received, but not information obtained 
prior to that time.  
 
Even after you withdraw your permission, ___________________________ may continue to use and share 
information needed for the integrity of the study; for example, information about an unexpected or bad side 
effect you experienced related to the study.  
 
Can you have access to your health information? 
Access may be limited while the study is in progress.  
 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is entirely voluntary and you may refuse to participate or discontinue 
participation at any time without penalty or loss of benefits to which you would normally be entitled.  Your 
decision about whether or not to participate in the study will not affect the care you receive. 
 
By agreeing to participate in this study, you are agreeing to return for follow-up visits until the study is 
completed.  Your participation in the study may be discontinued without your consent if you are unable to 
comply with the study procedures or if the study is stopped by the sponsor (Zimmer Spine), FDA or 
______________________. 
 

CMU2010-10S 
28March2012 v4 
 
 
Page 5 of 5 
 
 
COSTS/PAYMENTS 
There will be no additional cost to you to participate in this study.  You and your insurance company will be 
responsible for the fees incurred with this type of fusion surgery and subsequent follow-up visits as they would 
if you were not enrolled in the study. 
 
You will be paid $250 for the 24 month visit and an additional $100 if you are required to complete an annual 
visit after 24 months. 
 
 
QUESTIONS 
You will be notified of any significant new findings or developments during the study that may affect your 
health or safety.  You will also be notified of any significant findings which might cause you to change your 
mind about being in this study.   
 
If you have any questions about the research, or in the event of a research-related injury, please contact 
___________________________at _________________________.   
 
If you have any questions about your rights as a research subject, please contact the ________________ 
Institutional Review Board Office at ______________________________. 
 
 
IN CASE OF INJURY 
In the event of illness or physical injury resulting from taking part in this research study, medical treatment will 
be provided at _____________________.  You will be responsible for any costs not paid by your insurance 
company.  No other compensation is offered by Zimmer Spine.   
 
 
CONSENT 
I have reviewed the information in this document with the study representative.  I have had time to read and 
think about my participation.  I have had all of my questions answered.  I hereby give my consent to participate 
in this research study and agree that my personal health information can be collected, used and shared by the 
researchers and staff for the research study described in this form.  I will receive a signed copy of this consent 
form. 
 
 
 
___________________________ 
 
____________________________  
______________ 
Name of Subject (Print) 
 
 
Signature 
 
 
 
 
Date 
 
 
 
___________________________ 
 
____________________________  
______________ 
Name of Person Obtaining 
 
 
Signature 
 
 
 
 
Date 
Consent/Authorization (Print)