Guidance for Industry and FDA Staff 
 
Non-clinical Information for 
Femoral Stem Prostheses  
 
 
Document issued on:  September 17, 2007 
 
 
For questions regarding this document, contact Mr. John Goode (john.goode@fda.hhs.gov) or Ms. 
Elizabeth Frank (elizabeth.frank@fda.hhs.gov) at 240-276-3676. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Orthopedic Joint Devices Branch 
Division of General, Restorative and Neurological Devices 
Office of Device Evaluation 
  Contains Nonbinding Recommendations 
 
Preface 
 
 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of Human 
Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 
1061, (HFA-305), Rockville, MD, 20852.  Alternatively, electronic comments may be submitted 
to http://www.fda.gov/dockets/ecomments.  When submitting comments, please refer to the exact 
title of this guidance document.  Comments may not be acted upon by the Agency until the 
document is next revised or updated.   
 
 
Additional Copies 
 
Additional copies are available from the Internet at:  
http://www.fda.gov/cdrh/ode/guidance/1647.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 240-
276-3151 to receive a hard copy.  Please use the document number (1647) to identify the 
guidance you are requesting. 
 
 
  ii   Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  INTRODUCTION.................................................................................................................1 
The Least Burdensome Approach............................................................................................2 
II.  SCOPE...................................................................................................................................2 
III.  DEVICE DESCRIPTION....................................................................................................3 
IV.  STERILITY...........................................................................................................................4 
V.  BIOCOMPATIBILITY........................................................................................................4 
VI.  FATIGUE PROPERTIES....................................................................................................4 
A.  STEM FATIGUE TEST METHODS............................................................................................5 
B.  FEMORAL NECK FATIGUE TEST METHODS...........................................................................6 
C.  FATIGUE TEST METHODS FOR NOVEL STEM MATERIALS AND DESIGNS...............................7 
D.  FINITE ELEMENT ANALYSIS..................................................................................................8 
E.  FATIGUE TEST RESULTS.......................................................................................................8 
VII.  MODULAR CONNECTIONS, FRETTING AND CORROSION TESTING................8 
VIII. CLINICAL DATA................................................................................................................9 
IX.  TEST REPORTING.............................................................................................................9 
A.  TEST FACILITY INFORMATION..............................................................................................9 
B.  TEST OBJECTIVES.................................................................................................................9 
C.  MATERIALS AND METHODS..................................................................................................9 
D.  PROTOCOL DEVIATIONS.....................................................................................................10 
E.  TEST PARAMETERS AND ACCEPTANCE CRITERIA...............................................................10 
F.  EXPERIMENTAL DATA........................................................................................................10 
G.  TEST RESULTS....................................................................................................................10 
H.  DATA ANALYSIS.................................................................................................................10 
I.         CONCLUSIONS.....................................................................................................................10 
J.     BIBLIOGRAPHY...................................................................................................................10 
X.  LABELING.........................................................................................................................11 
APPENDIX A.  APPLICABLE REGULATIONS AND PRODUCT CODES........................12 
 
 
  iii   Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Non-clinical Information for Femoral Stem 
Prostheses 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance. 
 
I.  Introduction 
FDA has developed this guidance document for members of industry who submit and FDA staff 
who review non-clinical tests and labeling of femoral stem prostheses.  The terms you and 
your in this document refer to members of industry, also known as sponsors, submitters, or 
applicants.  The terms we, us, and our refer to FDA.  You should use this guidance to assist 
you in determining the appropriate non-clinical information and non-clinical testing to submit in 
premarket notifications (510(k)s), premarket approval (PMA) applications, and investigational 
device exemptions (IDEs) that include a femoral stem prosthesis.     
 
This guidance document is not intended to describe all elements required in 510(k)s, IDEs, or 
PMAs.  This guidance document supplements other FDA publications on 510(k), IDE, and PMA 
submissions and is not a replacement for these documents.  In addition to the guidance and other 
resources listed below, there may be other guidance documents specific to your type of device 
located on the FDA website, http://www.fda.gov/cdrh/guidance.html.   
 
Premarket Notification - 510(k) Information 
For general information on 510(k)s, refer to 21 CFR 807.87 and "How to Prepare a 510(k) 
Submission" in CDRH's Device Advice at http://www.fda.gov/cdrh/devadvice/314.html.  The 
guidance document Guidance for Industry and FDA Staff; Format for Traditional and 
Abbreviated 510(k)s at http://www.fda.gov/cdrh/ode/guidance/1567.pdf provides guidance 
on how to format an original submission for a Traditional or Abbreviated Premarket 
Notification Submission (510(k)).   
 
Investigational Device Exemption (IDE) Information  
For general IDE information, refer to 21 CFR Part 812 or to IDE Device Advice available at 
http://www.fda.gov/cdrh/devadvice/ide/index.shtml.  
 
  1   Contains Nonbinding Recommendations 
 
Premarket Approval Application (PMA) Information  
For general PMA information, refer to 21 CFR 814 or 
http://www.fda.gov/cdrh/devadvice/pma/app_methods.html.  In addition, there may be other 
guidance documents specific to your type of device located on the FDA website, 
http://www.fda.gov/cdrh/guidance.html.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe should be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered 
the burden that may be incurred in your attempt to follow the guidance and address the issues 
we have identified.  We believe that we have considered the least burdensome approach to 
resolving the issues presented in the guidance document.  If, however, you believe that there 
is a less burdensome way to address the issues, you should follow the procedures outlined in 
the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available 
on our Center web page at http://www.fda.gov/cdrh/modact/leastburdensome.html.  
 
II.  Scope 
This guidance addresses the development of non-clinical information, testing, and labeling of femoral 
stem prostheses.  The recommendations in this document may be used for class II and class III femoral 
stem prostheses intended as components for cemented or uncemented (i.e., press-fit or for biological 
fixation) hemi or total hip replacement systems.1  Femoral stems have a neck and shaft, which extends 
into the intramedullary canal, and may have either an integral femoral head or cone designed to accept 
modular heads.  This document outlines the information we recommend you include for the femoral 
neck, shaft, and head (e.g., device description, sterility, biocompatibility, modular connection, head 
selection when determining femoral neck and stem strength).  However, this guidance does not address 
the interaction of femoral heads and acetabular components (e.g., wear, range of motion, clearance, 
interfacial forces, constraint).  If you have any questions on these topics, please contact the Orthopedic 
Joint Devices Branch. 
                                                 
1 See table of regulations and product codes in Appendix A.   
  2   Contains Nonbinding Recommendations 
 
 
III.  Device Description  
FDA recommends that you identify your device by the applicable classification regulation and 
corresponding product code(s).  See Attachment A of this guidance for a listing of regulations and 
product codes.  In addition, we recommend that you provide the following information: 
  name of the component, each of its parts, and part numbers 
  description of the geometry of each component and function of each design feature 
  dimensions for the entire range of available sizes 
  representative photograph of each component 
  engineering drawings 
  surface roughness of all surfaces (R ) (micrometers) 
a
  material composition of each component 
  information about the manufacturing processes that determine the material microstructure, 
and hence, its properties (e.g., heat treatments) 
  characterization of coatings or surface modifications.  For guidance, refer to Guidance 
Document for Testing Orthopedic Implants with Modified Metallic Surfaces 
Apposing Bone or Bone Cement2 at and/or the 510(k) Information Needed for 
Hydroxyapatite Coated Orthopedic Implants.3  
  information about all modular connections, including how the parts are assembled and 
disassembled  
  listing and brief description of any surgical instrumentation unique to the implantation of 
the femoral stem 
 
If your stem geometry, materials, and/or sizes are identical to one of your previously legally 
marketed stems, we recommend that you identify the submission numbers, stems, materials, 
and/or sizes. 
 
For engineering drawings, you should submit fully-dimensioned drawings for each size showing 
part numbers.  Alternatively, you should supply representative drawings with a table of critical 
dimensions noted for each size.  Engineering drawings for the stems should specifically illustrate 
the dimensions and tapers of the femoral neck; details of all modular connections, if applicable; 
and shape and dimensions of the femoral stem cross-section at the potting level.  (See Potting 
Level discussion in Section VI.A.2.c.) 
 
                                                 
2 http://www.fda.gov/cdrh/ode/827.html
3 http://www.fda.gov/cdrh/ode/047.html
  3   Contains Nonbinding Recommendations 
 
Regarding material composition of each component, you should include any voluntary standards 
to which the material conforms (any difference between the final product and the criteria in the 
referenced standard should be itemized and justified), trade names, establishments that process 
materials, reference numbers of any previous submission to FDA, or another relevant reference, 
that more fully characterizes the material (e.g., master file, 510(k), literature article). 
 
IV.  Sterility 
FDA recommends that you provide sterilization information described in the guidance entitled, 
Updated 510(k) Sterility Review Guidance K90-1.4  The device should be sterile with a 
sterility assurance level (SAL) of at least 1 x 10-6 using a sterilization cycle that has been 
validated in accordance with the Quality System regulation (21 CFR Part 820). 
 
V.  Biocompatibility 
FDA recommends that you conduct biocompatibility testing as described in the guidance, Use of 
International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: 
Evaluation and Testing5 for tissue/bone contacting, permanent implanted devices. 
 
If the subject device has identical materials to a predicate device, with the same type and duration 
of patient contact, you may identify the predicate device in lieu of performing the 
biocompatibility testing.   
 
If you cannot identify a predicate device that utilizes the identical materials, and the materials in 
your device do not conform to one of the FDA recognized consensus standards at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm, we recommend that 
you evaluate the biocompatibility of the materials in your device as described in ASTM F748 
and/or ISO 10993-1.   
 
VI.  Fatigue Properties 
FDA recommends that you provide the information below to evaluate the material and 
performance characteristics of your final, worst-case device(s).  If sterilization affects the device 
performance, the tested device should be sterilized. 
 
To demonstrate that the femoral stem will continue to function without failure in the intended 
patient population, you should perform a fatigue test on your worst-case femoral stem(s).  In 
particular, we recommend using the test methods below to characterize the fatigue properties of 
the femoral stem.  For each test method used, there may be a different worst-case stem.  In 
addition, there may be femoral stem fatigue test methods (e.g., proximal stem fatigue testing), 
other than those outlined below, that mimic demonstrated clinical failure modes that your 
protocol should address.   
 
                                                 
4 http://www.fda.gov/cdrh/ode/guidance/361.html.   
5 http://www.fda.gov/cdrh/g951.html. 
  4   Contains Nonbinding Recommendations 
 
If you believe fatigue testing is not necessary, you should provide a rationale in your submission.  
In addition to the bench testing identified in this guidance, FDA may recommend you perform a 
clinical evaluation of new or significantly different femoral stem materials or designs.  If a 
clinical study is necessary, please see Section VIII:  Clinical Data for additional information. 
A. Stem Fatigue Test Methods 
FDA recommends you perform stem testing as described below.  For novel stem materials 
(e.g., polymer, polymer composite) and designs (e.g., resurfacing femoral stems), please refer 
to Section VI.C entitled, Fatigue Test Methods for Novel Stem Materials and Designs.  The  
performance standards associated with the fatigue test methods are outlined in Section VI.E.1. 
 
1.  Recommended Standards 
We recommend the use of standards listed below or equivalent methods: 
  ASTM F1612-95 (Reapproved 2005) Standard Practice for Cyclic Fatigue Testing 
of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion. 
  ASTM F1440-92 (Reapproved 2002)   Standard Practice for Cyclic Fatigue 
Testing of Metallic Stemmed Hip Arthroplasty Femoral Components without 
Torsion.  FDA believes this standard is appropriate only for stems that are not 
susceptible to the additional effects of torsional loading (e.g., stems with round 
cross-sections).   
  ISO 7206-4:2002  Implants for surgery-Partial and total hip joint prostheses- Part 
4:  Determination of endurance properties of stemmed femoral components.  You 
should adjust the potting level described in this standard for stems less than 
200mm to that described in the Potting Level Section VI.A.2.c.  
 
2.  Fatigue Testing Considerations 
 
a.  Worst-Case Design 
We recommend that you test the stem dimensions and tolerances that produce the 
highest stressed components and greatest damage (i.e., worst-case).  You should 
provide a rationale that explains how the following factors were considered in 
selecting your worst-case design: stem diameter, stem length, head and neck offset, 
modular connections, and material (i.e., substrate, modified surface). 
 
b.  Potting Medium 
You should describe the potting medium composition.  We recommend you use a 
bone cement or a material that is mechanically similar. 
 
c.  Potting Level 
If you use the test method described in ISO 7206-4:2002, we recommend using a 
potting level at a minimum of 80 mm  2mm below the center of the head as 
measured vertically along the load application line from the center of the head to the 
potting level.  Alternatively, if you follow ASTM F2068-03 and the test methods 
  5   Contains Nonbinding Recommendations 
 
described in ASTM F1612-95 (Reapproved 2000) or F1440-92 (Reapproved 2002), 
we recommend using a potting level with a minimum unsupported implant length 
of 50mm  2mm. 
 
For very short stems that lack a sufficient potting medium to maintain fixation for the 
duration of the fatigue test, we recommend that the length of stem embedded in the 
potting medium should be, at most, one third of the total femoral stem length 
measured vertically from the center of the head to the distal tip.  
 
If you choose to rely on ISO 7206-8:1995 as a performance criterion and as a basis 
for comparing the fatigue testing results of the subject device to the majority of 
legally marketed devices that have been tested using ISO 7206-4:1989, ASTM 
F1612-95 (Reapproved 2000) or F1440-92 (Reapproved 2002), we recommend you 
use a potting level as described above.  For stems less than 200mm, therefore, the 
potting level FDA recommends differs from the protocol outlined in ISO 7206-
4:2002.   
 
You may need to adjust the potting level such that stress risers (e.g., stems with 
design features such as slots, ribs, changes in material, surface characteristics, or 
modular connections) that are near the potting level are above the potting level. 
 
We recommend you report the stem shape and diameter at the potting level.   
 
d.  Lateral Head Deflection 
We recommend that you measure the lateral head deflection under maximum load at 
the initiation of each test and include this information in your maximum bending 
moment calculation.  FDA recommends you include exceeding a pre-defined 
deflection limit as a stem failure.  Therefore, you should monitor lateral head 
deflection during the test and record deflections that exceed the deflection limit 
defined in your protocol.   
B. Femoral Neck Fatigue Test Methods 
FDA recommends you perform femoral neck fatigue testing as described below.  The 
performance standards associated with this method are outlined in Section VI.E.2. 
1.  Recommended Standard 
We recommend using the standard listed below or an equivalent method.  
  ISO 7206-6:1992 Implants for surgery-Partial and total hip joint prostheses- Part 4:  
Determination of endurance properties of stemmed femoral components.  You 
should follow the procedure outlined in clause 7.2. 
 
2.  Fatigue Testing Considerations 
 
a.  Worst-Case Design 
  6   Contains Nonbinding Recommendations 
 
We recommend that you test the femoral neck with dimensions and tolerances that 
produce the highest stressed components and greatest damage (i.e., worst-case).  You 
should provide a rationale that explains how the following factors were considered in 
selecting your worst-case design: head and neck offset; modular connections; and 
material (i.e., substrate, modified surface).  
 
b.  Potting Medium 
You should describe the potting medium composition and use a bone cement or a 
material that is mechanically similar. 
C. Fatigue Test Methods for Novel Stem Materials and Designs 
FDA may recommend that you conduct additional non-clinical or clinical testing when the in 
vivo loading profile of the new stem significantly differs from that of the stems for which the 
ASTM and ISO standards cited in this guidance were designed.  FDA believes stems with 
new or significantly different stem materials or designs are likely to have significantly 
different loading profiles.  Examples of these include polymer or polymer composites 
materials and resurfacing femoral stem designs.  Any additional non-clinical testing of these 
materials and designs should address the following factors. 
1.  Polymer or Polymer Composite Stems 
The standards in Section VI.A.1 include test procedures that assume proximal support for 
the stem has been lost leading to distal stem fatigue failure.  These test procedures may 
not be appropriate for new polymer or polymer composite stem designs that fail at a load 
and/or number of cycles below what is described below (Section VI.E.1) due to new 
failure mechanisms.  You may test these new stem designs by other testing methods, 
provided there is adequate clinical evidence, stress analyses, and mechanical bench testing 
that: 
 
  justifies the load configurations and validates the test model; and 
 
  demonstrates that the clinical failure mechanisms of the new stem (e.g., 
delamination, creep, shear failure, crazing, or chemical attack of polymer 
composite stems) would substantially deviate from failure mechanisms that would 
result if tested by ASTM F1612-95 (Reapproved 2000), F1440-92 (Reapproved 
2002), or ISO 7206-4:2002 (i.e., fatigue crack in the distal shaft). 
 
You should also provide a scientific rationale that the components and sizes you selected 
are representative of a worst-case scenario.  
 
2.  Resurfacing Femoral Stems 
For resurfacing femoral stem prostheses, we recommend you complete cantilever fatigue 
testing for 5 million cycles.  You should provide a complete test report containing fatigue 
strength testing of the representative worst-case stem of the femoral component under 
worst case physiological testing and loading conditions.  You should include copies of all 
supporting literature references.  In addition, you should explain why the component and 
methods you selected are representative of a worst-case scenario. 
 
  7   Contains Nonbinding Recommendations 
 
D. Finite Element Analysis 
We believe finite element analysis (FEA) is primarily a development and design optimization 
tool, rather than a method by which physical performance of final devices can be 
demonstrated.  For example, FEA may be used to identify the worst-case design for 
experimental testing.  However, computer models may be appropriate to evaluate functional 
characteristics, if appropriate material properties and functional constraints are included and 
the computer models have been validated with experimental tests. 
 
E. Fatigue Test Results 
Your performance results for femoral stem and neck fatigue testing may be analyzed as 
follows.     
 
1.  Femoral Stem 
When conducting the ISO/ASTM standard test methods, as described in Section VI.A.1, 
we recommend that you do the following: 
  test six femoral stems and compare your results to the acceptance criteria given in 
either ISO 7206-8:1995 (cyclic loading with a minimum load of 300N and a 
maximum load of 2.3kN for five million cycles) or ASTM F2068-03 (clause 
6.1.1).  
  alternatively, the demonstrated fatigue strength of the stem should equal or exceed 
the demonstrated fatigue strength of a comparable legally marketed predicate 
femoral stem.  We recommend that you test six devices for five million cycles.  In 
addition, we recommend you provide a rationale that the components and methods 
you selected are representative of a worst-case scenario.  You should consider 
using the potting levels as outlined above (Section VI.A.2.c). 
 
2.  Femoral Neck  
When conducting the ISO standard test method, we recommend that you do the following: 
  test six femoral stems and compare your results to the acceptance criteria in ASTM 
F2068-03 (clause 6.1.3). 
  alternatively, demonstrated fatigue strength of the neck should equal or exceed the 
demonstrated fatigue strength of a comparable legally marketed predicate femoral 
neck.  We also recommend that you test six devices for ten million cycles.  In 
addition, we recommend you provide a rationale for the components and methods 
you selected are representative of a worst-case scenario. 
VII. Modular Connections, Fretting and Corrosion Testing  
In addition to addressing the fatigue properties of the stem, we recommend you perform modular 
connection, fretting, and corrosion testing  To evaluate modular connections, fretting, and 
corrosion, refer to Guidance Document for Testing Non-Articulating, Mechanically 
  8   Contains Nonbinding Recommendations 
 
Locked, Modular Implant Components.6  If you believe any of this testing is not necessary, 
you should provide a rationale in your submission.   
 
VIII. Clinical Data  
In addition to the bench testing identified in this guidance, it may be necessary to perform a 
clinical evaluation of new or significantly different femoral stem materials or designs to support a 
determination of substantial equivalence or a reasonable assurance of safety and effectiveness.  
The clinical study must be conducted under the Investigational Device Exemptions (IDE) 
regulation, 21 CFR Part 812, if performed in the U.S.  For PMA devices, see also 21 CFR 814.15.  
FDA believes that the device addressed by this guidance document is a significant risk device as 
defined in 21 CFR  812.3(m).7  In addition to the requirement of having an FDA-approved IDE, 
sponsors of such trials must comply with the regulations governing institutional review boards 
(21 CFR Part 56) and informed consent (21 CFR Part 50).  In addition, we recommend that you 
contact the Orthopedic Joint Devices Branch before you submit your IDE to discuss any 
questions you have related to the clinical study design. 
IX.  Test Reporting 
We recommend that you present test data in a complete test report (or summary, if applicable) 
that includes the elements described below.  
 
A. Test Facility Information 
You should provide the name and address of the facility performing the test.  You should also 
provide the names of the study director, investigators, and supervisors participating in the study.  
You should also provide the dates that testing was initiated and completed and the date the final 
report was completed. 
 
B. Test Objectives  
You should state the purpose of the test. 
 
C. Materials and Methods 
You should describe the samples tested, including the differences, if any, in the composition, 
material structure, and processing methods between the test samples and your device.  If you 
submit multiple device sizes or configurations for review, you should test the worst-case 
device(s) and provide a rationale for the devices selected.  You should also submit your test 
method or protocol.  It should contain enough detail so an individual familiar with femoral 
stem fatigue testing can interpret the test results.   
 
You should also describe the test system used and provide a schematic or clear photograph of 
the test setup.  You should also provide all assumptions of the test, including assumed 
physiological loading values and environmental conditions.  In addition, you should provide the 
load directions, magnitudes, potting level (see Potting Level discussion in Section VI.A.2.c), 
                                                 
6 See http://www.fda.gov/cdrh/ode/916.html
7 See http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf.  
  9   Contains Nonbinding Recommendations 
 
and the stem shape and diameter at the potting level.  You should also conduct a post-test 
failure analysis of the specimens that includes the following: 
  an identification of cracks; 
  an identification of plastic deformation; and  
  an identification of any other signs of failure, including the location of the point of failure 
initiation. 
 
D. Protocol Deviations 
You should describe any protocol deviations and their effect on the ability of the test data to 
support your conclusions.  
 
E. Test Parameters and Acceptance Criteria 
You should report the test parameters and acceptance criteria that you use, including:  
  an explanation of and rationale for critical test parameters;  
  specifications or acceptance and rejection criteria; and  
  a rationale that the specifications or acceptance and rejection criteria you selected are 
adequate for the clinical use of your device.  
 
F. Experimental Data 
We recommend that you submit all experimental data that includes enough information to 
support an independent analysis and conclusion. 
 
G. Test Results 
You should summarize your test results and include a statistical analysis where appropriate.  
The results should include a mean plus or minus standard error, or standard deviation.  You 
should provide a statistical analysis of the differences between the test results, where appropriate. 
 
H. Data Analysis  
You should analyze the data, including any outlying points and anomalous results, and explain 
whether the data meet acceptance criteria. 
 
I.  Conclusions  
We recommend that you describe the conclusions drawn from the test results and the clinical 
significance of the conclusions.  
 
J.  Bibliography 
You should provide a bibliography and include copies of all cited references pertinent to the 
report. 
 
  10   Contains Nonbinding Recommendations 
 
X.  Labeling 
A 510(k) must include labeling in sufficient detail to satisfy the requirements of 21 CFR 
807.87(e).  A PMA must include all proposed labeling in accordance with 21 CFR 814.20(b)(10).  
The following suggestions will assist you in preparing labeling that fulfills the requirements of 21 
CFR Part 801.8   
 
Directions for use 
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate 
directions for lay use.  Nevertheless, we recommend providing clear and concise information 
that delineates the technological features of the specific device and how the device is used on 
patients.  The instructions should encourage participation in local/institutional training 
programs designed to familiarize users with the features of the device and instructions on how 
to use the device in a safe and effective manner.  Instructions should also describe the 
intended use, indications, and method of fixation. 
 
Adequate instructions for use are essential, especially for small or short hip stems, so a 
physician can make an educated choice.  Instructions should identify factors that may 
influence device performance, such as patients age, activity level, weight, bone, and muscle 
quality.  These instructions may be in the form of a precaution, warning, or a note to the 
surgeon in the labeling.  Generally, contraindicated patient weight limits are not needed in the 
labeling for femoral hip stem systems. 
 
In addition, the instructions for use should identify known adverse events.  For example, stem 
loosening or fracture, particularly of smaller sized stems, is most likely to occur in patients 
who are young, physically active, have poor bone quality and/or are heavy.   
 
 
                                                 
8 Although final labeling is not required for 510(k) clearance, final labeling must comply with the 
requirements of 21 CFR 801 before introducing a medical device into interstate commerce.  In 
addition, final labeling for prescription medical devices must comply with 21 CFR 801.109.  
Labeling recommendations in this guidance are consistent with the requirements of Part 801. 
  11   Contains Nonbinding Recommendations 
 
Appendix A.  Applicable Regulations and Product Codes
 
Classification  Description  Product  Device Name 
21 CFR section  Code 
888.3300  Hip joint metal constrained cemented or   KXD  prosthesis, hip, constrained, metal 
uncemented prosthesis. 
888.3310  Hip joint metal/polymer constrained  KWZ  prosthesis, hip, constrained, 
cemented   cemented or uncemented, 
or uncemented prosthesis.  metal/polymer 
888.3320  Hip joint metal/metal semi-constrained, with  JDL  prosthesis, hip, semi-constrained 
a cemented acetabular component,  (metal cemented acetabular 
prosthesis  component) 
888.3330  Hip joint metal/metal semi-constrained, with  KWA  prosthesis, hip, semi-constrained 
an uncemented acetabular component,  (metal uncemented acetabular 
prosthesis  component) 
888.3340  Hip joint metal/composite semi-constrained  KMC  prosthesis, hip, semi-constrained,  
cemented prosthesis.  composite/metal 
888.3350  Hip joint metal/polymer semi-constrained  JDI  prosthesis, hip, semi-constrained,  
cemented prosthesis.  metal/polymer, cemented 
888.3353  Hip joint metal/ceramic/polymer semi- MAY  prosthesis, hip, semi-constrained, 
constrained cemented or nonporous    metal/ceramic/polymer, cemented or 
uncemented prosthesis.    non-porous cemented, osteophilic 
  finish 
 
LZO  prosthesis, hip, semi-constrained, 
  metal/ceramic/polymer, cemented or 
  non-porous, uncemented 
MEH   
prosthesis, hip, semi-constrained, 
uncemented, metal/polymer, non-
porous, calcium-phosphate 
888.3358  Hip joint metal/polymer/metal semi- LPH  prosthesis, hip, semi-constrained, 
constrained porous-coated uncemented    metal/polymer, porous uncemented 
prosthesis.     
MBL  prosthesis, hip, semi-constrained, 
  uncemented, metal/polymer, porous 
888.3360  Hip joint femoral (hemi-hip) metallic  JDG  prosthesis, hip, femoral component, 
cemented or uncemented prosthesis.    cemented, metal 
   
KWL  prosthesis, hip, hemi-, femoral, metal
   
LWJ  prosthesis, hip, semi-constrained,  
  metal/polymer, uncemented 
   
JDD  prosthesis, upper femoral 
888.3380  Hip joint femoral (hemi-hip) trunnion- JDH  prosthesis, hip, hemi-, trunnion-
bearing metal/polyacetal cemented  bearing, femoral, metal/polyacetal 
prosthesis. 
  12   Contains Nonbinding Recommendations 
 
Classification  Description  Product  Device Name 
21 CFR section  Code 
888.3390  Hip joint femoral (hemi-hip) metal/polymer  KWY  prosthesis, hip, hemi-, femoral, 
cemented   metal/polymer, cemented or 
or uncemented prosthesis.  uncemented 
888.3400  Hip joint femoral (hemi-hip) metallic  KXA  prosthesis, hip, femoral, resurfacing 
resurfacing prosthesis. 
888.3410  Hip joint metal/polymer   KXB  prosthesis, hip, pelvifemoral 
or ceramic/polymer semiconstrained  resurfacing,  
resurfacing cemented prosthesis.  metal/polymer 
 
  13