Contains Nonbinding Recommendations
Orthopedic Fracture Fixation Plates  
Performance Criteria for Safety and 
Performance Based Pathway
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
GUIDANCE
Document issued on April 11, 2022.
For questions about this document, contact OHT6: Office of Orthopedic Devices/DHT6C: 
Division of Restorative, Repair and Trauma Devices at (301) 796-5650. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
1 Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2022-D-0552. 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.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 19044 and complete title of the guidance in the request.
2 Contains Nonbinding Recommendations
Orthopedic Fracture Fixation Plates  
Performance Criteria for Safety and 
Performance Based Pathway
_____________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.
I.  Introduction
This guidance provides performance criteria for Orthopedic Fracture Fixation Plates in support 
of the Safety and Performance Based Pathway.1 Under this framework, submitters (you) 
planning to submit a 510(k) using the Safety and Performance Based Pathway for Orthopedic 
Fracture Fixation Plates will have the option to use the performance criteria proposed in this 
guidance to support substantial equivalence, rather than a direct comparison of the performance 
of the subject device to that of a predicate device.
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.2 For more information 
regarding use of consensus standards in regulatory submissions, please refer to the FDA 
guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices.3  
This guidance is being implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or appropriate (section 701(h)(1)(C)(i) 
of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document 
presents a less burdensome policy that is consistent with public health. This guidance document 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
3 Contains Nonbinding Recommendations
is being implemented immediately, but it remains subject to comment in accordance with the 
Agencys good guidance practices.
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited. The use of the word should in Agency 
guidance means that something is suggested or recommended, but not required. 
II.  Background
In September 2019, FDA issued a guidance to describe an optional pathway  the Safety and 
Performance Based Pathway4  for certain, well understood device types, where a submitter 
could demonstrate that a new device meets FDA-identified performance criteria to demonstrate 
that the device is as safe and effective as a legally marketed device. In order to identify the 
specific set of performance criteria appropriate to satisfy a submitters comparison to an 
appropriate predicate for a given device-type, FDA has determined that the performance criteria 
represent performance that meets the performance of one or more existing, legally marketed 
devices of that device type. Specifically, FDA relied on the experience and expertise of FDA 
staff, information in literature, and analyses of data available to FDA on legally marketed 
orthopedic fracture fixation plates to determine the performance criteria and associated testing 
methods that could support a finding of substantial equivalence for orthopedic fracture fixation 
plates as described in this guidance. FDA recognizes that in some cases, it may be more 
burdensome for a submitter to conduct testing against an appropriate predicate device to 
demonstrate equivalence for the necessary set of performance and technological characteristics 
than to demonstrate their device meets appropriate performance criteria established by FDA.  
Accordingly, we concluded that the optional device-specific Safety and Performance Based 
Pathway utilizing the performance criteria identified in this guidance provides a less burdensome 
policy consistent with the public health.
III.  Scope/Device Description
The devices that are the subject of this guidance are Class II non-spinal fracture fixation plates 
regulated under 21 CFR 888.3030, with the product code HRS (plate, fixation, bone). 
Additionally, the performance testing recommendations for non-spinal fracture fixation plates 
are harmonized with testing recommendations for the associated bone screws with product code 
HWC (screw, fixation, bone) regulated under 21 CFR 888.3040, which can be found in FDAs 
guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers  Performance Criteria for 
Safety and Performance Based Pathway5 (hereinafter Bone Screws and Washers Guidance). 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-
metallic-bone-screws-and-washers-performance-criteria-safety-and-performance 
4 Contains Nonbinding Recommendations
Intended Use/Indications for Use:
The fracture fixation plates that fall within the scope of this guidance document are intended for 
osteosynthesis (i.e., rigid fixation of opposing bone fragments for fracture fixation, osteotomy, or 
arthrodesis). The performance criteria identified in this guidance are applicable to fracture 
fixation plates used in the upper extremities and lower extremities and clavicle. 
Fracture fixation plates that are intended for mandibular, maxillofacial, cranial, and orbital 
fracture fixation or for use in the thorax (i.e., rib and sternum), spine, pelvis and femoral 
head/neck are outside the scope of this guidance document. 
For devices intended for new fracture types or abnormal bone biology (e.g., osteoporosis, 
metabolic bone diseases, metastatic cancer lesions, genetic disorders) within each anatomical 
location, additional information, in addition to testing outlined in this guidance, such as 
performance comparison to a predicate device, may be needed to demonstrate substantially 
equivalent fracture fixation performance. We recommend that you submit a Pre-Submission6 to 
engage in discussion with FDA prior to submission of the 510(k).  
Device Design Characteristics:
Fracture fixation plates may have varying designs to account for specific anatomical locations. 
The scope of this guidance document includes traditional fracture fixation plates that are 
positioned entirely on the cortical surface, over the osteosynthesis site. The scope is limited to 
plating systems where the worst case device configuration can be evaluated using four-point 
bend testing per ASTM F382 Standard Specification and Test Method for Metallic Bone Plates 
(e.g., straight, tubular plates). Devices that fall within the scope of this guidance document 
consist of fracture fixation plates and screws manufactured from the following materials:
 ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium 
ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) 
 ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium 
Alloy for Surgical Implant Applications (UNS R56400)
 ASTM F1295 Standard Specification for Wrought Titanium-6 Aluminum-7Niobium 
Alloy for Surgical Implant Applications (UNS R56700) 
 ASTM F67 Standard Specification for Unalloyed Titanium, for Surgical Implant 
Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) 
 ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 
Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 
 ASTM F139 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5
Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
  ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum 
Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Premarket submissions should describe anatomical use location of each plate and identify the 
screws that are compatible with each plate. Submissions should include a geometric comparison 
6 See the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-program for more information.
5 Contains Nonbinding Recommendations
of each subject plate/screw combination to a legally marketed predicate plate/screw combination 
for use in the same anatomical region to demonstrate similarities in technological features. The 
following characteristics should be described for each component included in the submission and 
compared between the subject and predicate devices: 
 Plate characteristics:
o  Plate Footprint (Lengths, Widths, Shape)
o  Plate Prominence (Thickness)
o  Plate fixation (Number of screw holes and pattern) 
o  Compatible screw size(s)
o  Material 
 Screw characteristics (for screws associated with a particular plate):
o  Diameter
o  Overall length
o  Threaded length
o  Thread profile 
o  Fixed or variable angle and, if variable angle, a comparison of angulation 
allowed by the screws with respect to the plate
o  Locking or non-locking
o  Material
Sufficient description, such as detailed engineering drawings, should be provided to demonstrate 
that screws mate appropriately with the plates in order to perform their intended function.
Implants with the following features are outside the scope of this guidance for the Safety and 
Performance Based Pathway:
 Plating systems with non-uniform worst-case structurally critical regions that cannot 
physically fit between the loading rollers of a four-point bend test and/or do not maintain 
contact of all loading rollers throughout the test.7
 Devices with features intended to promote dynamization at the fracture site (i.e., 
secondary bone healing through callus formation)
 Combination products
 Resorbable devices
 Additively manufactured devices
 Devices with coatings
 Devices that utilize surgical techniques or associated instruments outside the standard of 
care
 Devices with complex geometries, modularity, non-traditional technological 
characteristics or unique technological characteristics that impact the risk of soft tissue 
irritation or the structural integrity of the construct (e.g., design features that warrant 
fatigue evaluations, dynamic components or mechanisms, non-traditional plate and 
7 As stated in ASTM F382, plates with non-uniform segments (e.g., asymmetry, curvatures) may not be able to be 
adequately evaluated in four-point bend testing. Uniform cross sections are preferred for this test as non-uniform 
designs may deflect asymmetrically resulting in uneven loading under the loading rollers.  
6 Contains Nonbinding Recommendations
screw interfaces, screw characteristics that differ substantially in design from predicates 
or recognized consensus standards for orthopedic bone screws).
 Devices sterilized using novel sterilization methods as described in FDAs guidance 
Submission and Review of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile.8
FDA may determine, on a case-by-case basis, that additional data are necessary to evaluate 
whether the device is appropriate for the Safety and Performance Based Pathway. In situations 
where you determine that additional testing outside of those identified in this guidance are 
necessary to make a determination regarding whether the device is appropriate for the Safety and 
Performance Based Pathway, we would encourage you to submit a Pre-Submission9 to engage in 
discussion with FDA prior to submission of the 510(k).  
IV.  Testing Performance Criteria
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, we do not expect you to provide direct comparison testing 
against a legally marketed predicate device to demonstrate substantially equivalent performance 
characteristics. To ensure that the performance criteria outlined in this guidance remain 
contemporary and to take into account relevant data from recent clearances, FDA recommends 
that you provide a results summary for all tests evaluated in addition to the other submission 
information (e.g. Declaration of Conformity (DoC)) recommended below for each test or 
evaluation below. Consistent with FDA policy for all 510(k) submissions, for all 510(k) 
submissions under the Safety and Performance Based Pathway, FDA may request and review 
underlying data demonstrating that a new device meets the FDA-identified performance criteria 
and testing methodology, as necessary. Unless otherwise identified in the sections below, test 
information such as results summary, test protocols, and complete test reports should be 
submitted as part of the 510(k) as described in FDAs guidance Safety and Performance Based 
Pathway. For additional information regarding the submission of non-clinical bench testing 
information, please see FDAs guidance Recommended Content and Format of Non-Clinical 
Bench Performance Testing Information in Premarket Submissions.10
Mechanical Bench Testing
The following mechanical tests should be performed in conformance with the FDA currently-
recognized version of ASTM F382 Standard Specification and Test Method for Metallic Bone 
Plates and ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone 
Screws. You should provide a rationale identifying how you identified the worst-case design for 
each bench test. A complete worst-case rationale for plates should address the indications (e.g., 
anatomical location), geometry (e.g., the location between the outermost screw holes that will 
have the highest stress under loading), and labeling (e.g.  rehabilitation activity, post-operative 
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket 
7 Contains Nonbinding Recommendations
loading). For each anatomical location, we recommend that you perform testing on plate designs 
that represent the worst case for bending strength and bending structural stiffness performance. 
The worst case for compatible screw designs should also be identified. All mechanical testing 
should be performed on the final, finished versions of the devices unless certain processes (e.g., 
sterilization) can be rationalized to have no impact on the mechanical strength of the device. 
Acceptance criteria are listed below for each test.11
For each mechanical test below, you should provide a report as specified in the relevant reporting 
sections of ASTM F382 or ASTM F543, in addition to a DoC to the consensus standard. Any 
protocol deviations should be thoroughly described and justified; however, note that certain 
protocol deviations may invalidate comparison to the performance criteria listed below, resulting 
in the need for submission of a Traditional, Special, or Abbreviated 510(k), as appropriate. 
Compatible Screw Mechanical Testing 
FDAs Bone Screws and Washers Guidance can be leveraged to assess mechanical testing of 
bone screws that are compatible with the fracture fixation bone plate. The worst-case bone screw 
size that is compatible with the worst-case bone plate for each anatomical location should be 
selected for mechanical testing. Torsional Strength and Driving Torque Testing of the screw 
should be performed and compared to the performance criteria identified in Section III of the 
Bone Screws and Washers Guidance. 
FDA does not consider individual screw pullout strength testing (Section III, Test #3, in the 
Bone Screws and Washers Guidance) to be necessary for demonstrating that a plating system has 
substantially equivalent fixation because multiple screws are intended to be used with the plating 
system to minimize the risk of en-bloc plate pull-out. Therefore, FDA does not recommend the 
use of the Axial Pullout Strength criteria for screws used with a subject plating system because 
these criteria are representative of partially threaded bone screws, which may not be generally 
comparable to all screws types intended for use with plates.
FDA believes that the substantial equivalence of construct fixation can be demonstrated through 
a comparison of the number of screws used with each plate and a comparison of subject screws 
to the predicate (e.g., the number of screw holes, the screw type, screw diameter, overall length, 
threaded length and thread profile). This comparative approach can accommodate the variety of 
plates and their screw types that have been cleared through 510(k) and provides a least 
burdensome method that is sufficient to demonstrate substantial equivalence. 
For screws intended for stand-alone use outside of the plating construct, the Bone Screws and 
Washers Guidance is applicable in its entirety.  
 
Bone Plate Mechanical Testing
11 It should be noted that ASTM F382 and ASTM F543 are recognized in full by FDA.  FDA believes that for the 
purposes of the Safety and Performance Based Pathway, the testing, methods and criteria identified in this section on 
mechanical bench testing represent the least burdensome approach to demonstrating substantial equivalence for this 
pathway, although alternative or additional methods or acceptance criteria are identified in the recognized consensus 
standard for some tests. The supplementary information sheet (SIS) for ASTM F382 and ASTM F543 will be 
revised to reflect this information upon finalization of this guidance.
8 Contains Nonbinding Recommendations
1.  Test name: Static Four-Point Bending
Methodology: FDA-recognized version of ASTM F382 Standard Specification and Test 
Method for Metallic Bone Plates. The worst-case bone plate(s) for each anatomic region 
should be selected for mechanical testing.
Performance Criteria: 
Intended Anatomical Location of Bone Plate Minimum Bending  Minimum 
Strength (N-m) Bending 
Structural 
Stiffness 
(N-m2)
Upper  Humerus  11.6 4.39
Extremity Elbow (Distal Humerus and Ulna) 6.7 0.89
Hand, Wrist and Forearm 1.6 0.18
Lower  Femur & Proximal Tibia 26.3 8.66
Extremity Distal Tibia 11.9 3.49
Fibula 2.3 0.17
Foot 1.2 0.13
Other Clavicle 11.9 1.69
Performance Criteria Source: Criteria are based on aggregated mechanical testing data 
submitted to FDA in 510(k) submissions for orthopedic bone plates previously found to 
be substantially equivalent. 
Additional Considerations: A minimum of five samples should be tested for each 
worst-case plate being evaluated. In addition, analysis of the data available to FDA on 
existing devices has shown that five samples should be adequate based on the mean 
bending strength and mean bending structural stiffness testing results compared to the 
criteria for each nominal diameter. To be considered a successful result, either: (1) All 
samples should meet or exceed the acceptance criteria listed above, or (2) the average of 
all samples should meet or exceed the criteria above and the standard deviation should be 
 10% of the calculated averages.
Submission Information: Results summary and DoC 
Sterilization (devices labeled as sterile) and Reprocessing (end-user sterilized) Validation 
2.  Test name: Sterilization (for devices labeled as sterile) and Reprocessing (end-user 
sterilized)
Methodology: Current FDA recognized version of the following consensus standards (as 
applicable):
 International Organization for Standardization (ISO) 17665-1: Sterilization of 
health care products  Moist heat  Part 1: Requirements for the development, 
validation, and routine control of a sterilization process for medical devices
 ISO 11135-1: Sterilization of health care products  Ethylene oxide- Part 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices
9 Contains Nonbinding Recommendations
 ISO 11137-1: Sterilization of health care productsRadiationPart 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices
 ISO 11607-1: Packaging for terminally sterilized medical devices  Part 1: 
Requirements for materials, sterile barrier systems and packaging systems
 ISO 11607-2: Packaging for terminally sterilized medical devices  Part 2: 
Validation requirements for forming, sealing and assembly processes
Performance Criteria: Validation testing should demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize to a sterility assurance level of 10-6, the 
device and device-specific instruments. 
Performance Criteria Source: FDAs guidance:
 Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile12
 Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling13
Submission Information: You should provide a description of the packaging (sterile 
barrier system) and how it will maintain the devices sterility, and a description of the 
package test methods, but not package test data. When using an Established Category A 
sterilization method, you should provide the information in Section V.A. of the FDA 
guidance Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile; generally, the validation data itself 
is not needed to demonstrate substantial equivalence. 
Biocompatibility Evaluation 
To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation 
you should use Attachment A of the FDA guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices  Part 1: Evaluation and testing within a risk 
management process,14 referred to in the rest of this document as the FDA Biocompatibility 
Guidance for brevity. FDA considers the devices covered by this guidance to be categorized as 
Implanted Devices in contact with tissue/bone with a permanent contact duration of > 30 days, 
and, accordingly, you should assess the endpoints below per Attachment A of the FDA 
Biocompatibility Guidance.
 Cytotoxicity
 Sensitization
 Irritation or Intracutaneous Reactivity
 Acute Systemic Toxicity
 Material-Mediated Pyrogenicity
 Sub-acute/Sub-chronic Toxicity
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled 
13 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-
devices-health-care-settings-validation-methods-and-labeling 
14 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
10 Contains Nonbinding Recommendations
 Genotoxicity
 Implantation
 Chronic Toxicity
 Carcinogenicity
Rationale in Lieu of Testing: If the subject device is manufactured from the identical raw 
materials using identical manufacturing processes as a predicate device with the same type and 
duration of tissue contact, and any changes in geometry are not expected to impact the biological 
response, this is typically sufficient to establish substantially equivalent biocompatibility if 
documentation such as that outlined in Attachment F of the FDA Biocompatibility Guidance is 
also provided.
Testing: In rare cases, if you determine that testing is needed to address some or all of the 
identified endpoints, FDA recommends that complete test reports be provided for all tests 
performed unless a declaration of conformity without supplemental information can be 
appropriately provided, as discussed in Attachment E of the FDA Biocompatibility Guidance. 
Any test-specific positive, negative, and/or reagent controls should perform as expected, and 
protocol deviations should be thoroughly described and justified; however, note that certain 
protocol deviations may invalidate comparison to the performance criteria listed below. As 
described in the FDA guidance, Safety and Performance Based Pathway,15 if a device cannot rely 
entirely on performance criteria identified by FDA to demonstrate substantial equivalence for its 
submission, it is not appropriate for the Safety and Performance Based Pathway program; 
however, the previously established 510(k) programs in which direct performance comparisons 
against appropriate predicates are conducted, including Traditional, Special, and Abbreviated 
510(k)s, remain available.
3.  Test name: Biocompatibility endpoints (identified from FDA Biocompatibility 
Guidance)
Methodology: Current FDA recognized versions of biocompatibility consensus standards
Performance Criteria: All direct tissue contacting components of the device and device-
specific instruments should be determined to have an acceptable biological response.
Performance Criteria Source: The FDA Biocompatibility Guidance
Additional Considerations: For any biocompatibility test samples with an adverse 
biological response, the biocompatibility evaluation should explain why the level of 
toxicity seen is acceptable. Some comparison testing against a legally marketed predicate 
may be necessary (and is considered appropriate under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the FDA Biocompatibility Guidance. 
For standard biocompatibility test methods that include comparison device control 
samples, the legally marketed comparison device control samples should perform as 
expected.
Submission Information: Refer to FDA Biocompatibility Guidance
15 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-
performance-based-pathway 
11