Contains Nonbinding Recommendations 
Spinal Plating Systems  Performance 
Criteria for Safety and Performance 
Based Pathway 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on December 11, 2020. 
The draft of this document was issued on September 20, 2019. 
For questions about this document, contact the DHT6B: Division of Spinal Devices at 301-796-
5650. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  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-2019-D-1647. 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 19008 and complete title of the guidance in the request.  Contains Nonbinding Recommendations 
Spinal Plating Systems  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 spinal plating systems 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 spinal plating systems 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  
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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 guidance means that something is suggested or 
recommended, but not required. 
                                                
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 
1  Contains Nonbinding Recommendations 
II.  Scope/Device Description 
The spinal plates that are the subject of this guidance are anterior cervical or anterior/lateral 
thoracolumbar spinal plating systems. These devices are Class II and are regulated under 21 CFR 
888.3060 with the product code KWQ (appliance, fixation, spinal intervertebral body). 
Intended Use/Indications for Use: The spinal plating systems that fall within the scope of this 
guidance document are intended for fixation to vertebral bodies (anteriorly in the cervical spine 
or anteriorly/laterally in the thoracolumbar spine) for the purpose of stabilizing the spine for 
fusion. Plating systems that attach to the posterior spine or the occiput are outside the scope of 
this guidance document. 
Device Design Characteristics: The spinal plating systems that fall within the scope of this 
guidance document consist of plates and associated fixed or variable angle screws, constructed 
solely from one of the following materials in conformance with the associated FDA-recognized 
consensus standard: 
  ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI 
(Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) 
  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). 
A dimensional comparison of the subject device should be performed, and the dimensions should 
fall within the dimensional ranges listed in Table 1. 
Table 1 - Size ranges for cervical and thoracolumbar spinal plating systems. 
Cervical Plates  Range* 
Number of Levels Treated  1 to 5 
Plate Length (hole-to-hole)  10 mm to 115 mm 
Plate Thickness/Profile**   3 mm 
Screw Diameter (Major)  3.5 mm to 4.5 mm 
Screw Length (Threaded Length)  10 mm to 26 mm 
Thoracolumbar Plates 
Number of Levels Treated  1 to 3 
Plate Length (hole-to-hole)  15 mm to 130 mm 
Plate Thickness/Profile**   7 mm 
Screw Diameter (Major)  5 mm to 7 mm 
Screw Length (Threaded Length)  15 mm to 70 mm 
* The dimensional ranges listed were derived from historical data submitted to FDA in 510(k) submissions for 
devices previously found substantially equivalent. 
2 Contains Nonbinding Recommendations 
** Largest thickness or profile of the subject plate should fall below the listed value. A minimum plate thickness is 
not specified; however thickness should be sufficient for the plate to meet the mechanical testing acceptance criteria 
outlined in this guidance. 
Cervical and thoracolumbar spinal plating systems with the following features are not eligible 
for the Safety and Performance Based Pathway via this guidance: 
  Devices that affix to the posterior spine or the occiput 
  Devices for which a 2-level cervical plate or a 1- or 2-level thoracolumbar plate is not 
representative of a worst-case construct for performance testing per the FDA currently 
recognized version of ASTM F1717 Standard Test Methods for Spinal Implant 
Constructs in a Vertebrectomy Model 
  Staples or plates with fixation mechanisms other than threaded screws 
  Devices with coatings 
  Combination products 
  Resorbable devices 
  Additively manufactured devices 
  Devices that are designed to allow motion post-implantation (e.g., plates designed to 
settle). 
  Buttress plating systems (i.e., plates that do not span at least one functional spinal unit) 
General guidance that is beyond the scope of this safety and performance guidance document 
regarding submission of a 510(k) for spinal plating systems (i.e., labeling), can be found in 
FDAs guidance Spinal System 510(k)s.4
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 determine whether the device is appropriate for the Safety and Performance Based 
Pathway, we encourage you to submit a Pre-Submission5 to engage in discussion with FDA prior 
to submission of the 510(k). 
III.  Testing Performance Criteria 
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, you do not need 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 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)) identified for each test or evaluation below. 
Unless otherwise identified in the submission information sections below, test information such 
as results summary, test protocols, or complete test reports should be submitted as part of the 
                                                
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-
fda-staff-spinal-system-510ks 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
3 Contains Nonbinding Recommendations 
510(k) as described in FDAs guidance, Safety and Performance Based Pathway.6 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.7
Mechanical Testing 
Static compression bending, static torsion, and dynamic compression bending should be 
performed in conformance with the FDA currently-recognized version of ASTM F1717 
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. We recommend 
that you perform all testing on plate system designs that represent worst-case (e.g., most likely to 
loosen or fail) final design versions. You should also provide a rationale identifying how you 
identified the worst-case design.  Acceptance criteria are listed below for each test, which 
include stiffness and yield values for the static tests and runout loads for the dynamic test.8
For each mechanical test below, you should provide a report as specified in the relevant reporting 
sections of ASTM F1717 and the Mechanical Testing section of FDAs guidance Spinal System 
510(k)s,9 in addition to a Declaration of Conformity (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. 
Note: ASTM F1717 specifies the active lengths of the longitudinal element to be 35 mm for 
cervical devices and 76 mm for lumbar devices (or as close to these dimensions as possible based 
on plate sizes available) to simulate connection across two spinal levels in the cervical and 
lumbar spine, respectively. However, since many thoracolumbar plating systems only contain 1-
level plates, significant modification to the specified 76 mm active length is necessary to 
simulate connection across a single spinal level. Therefore, data for 1-level and 2-level 
thoracolumbar plating systems were analyzed separately, and acceptance criteria are stratified for 
each test below. 
1.  Test name: ASTM F1717 - Static compression bending 
Methodology: ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a 
Vertebrectomy Model 
Performance Criteria: 
                                                
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket 
8 It should be noted that although ASTM F1717 is FDA-recognized in full, 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. 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-
fda-staff-spinal-system-510ks 
4 Contains Nonbinding Recommendations 
Table 2 Static compression bending acceptance criteria for cervical and thoracolumbar 
plating systems 
Test Parameter  Cervical (2-Level  Thoracolumbar (1- Thoracolumbar (2-
constructs)  level constructs)  level constructs) 
Static Compression 
Bending Stiffness  9.6 N/mm  45 N/mm  35 N/mm 
(N/mm) 
Static Compression 
75 N  230 N  360 N 
Bending Yield (N) 
Performance Criteria Source: Criteria are based on aggregated mechanical testing data 
submitted to FDA in 510(k) submissions for spinal plating systems previously found to 
be substantially equivalent.  
Additional Considerations: Testing should include a minimum of 5 samples consistent 
with ASTM F1717 (2018). In order 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 average. For testing of 1-level thoracolumbar plates, active 
length for the worst case should fall between 25 and 40 mm to be comparable to the 
criteria listed in the table above.  
Submission Information: Results summary and DoC 
2.  Test name: ASTM F1717 - Static torsion 
Methodology: ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a 
Vertebrectomy Model 
Performance Criteria: 
Table 3  ASTM F1717 static torsion acceptance criteria for cervical and thoracolumbar 
plating systems. 
Test Parameter  Cervical (2-Level  Thoracolumbar (1- Thoracolumbar (2-
constructs)  level constructs)  level constructs) 
Static Torsion 
Stiffness (N- 0.9 N-m/degree  5.6 N-m/degree  2.7 N-m/degree 
m/degree) 
Static Torsion Yield 
4.7 N-m  19 N-m  18 N-m 
(N-m) 
Performance Criteria Source: Criteria are based on aggregated mechanical testing data 
submitted to FDA in 510(k) submissions for spinal plating systems previously found to 
be substantially equivalent. 
Additional Considerations: Testing should include a minimum of 5 samples consistent 
with ASTM F1717 (2018). In order to be considered a successful result, either: (1) all 
5 Contains Nonbinding Recommendations 
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 average. For testing of 1-level thoracolumbar plates, active 
length for the worst case should fall between 25 and 40 mm to be comparable to the 
criteria listed in the table above. 
Submission Information: Results summary and DoC 
3.  Test name: ASTM F1717 - Dynamic compression bending fatigue test 
Methodology: ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a 
Vertebrectomy Model 
Performance Criteria: 
Table 4  ASTM F1717 dynamic compression bending acceptance criteria for cervical 
and thoracolumbar plating systems. 
Test Parameter  Cervical (2-Level  Thoracolumbar (1- Thoracolumbar (2-
constructs)  level constructs)  level constructs) 
Dynamic 
Compression 
40 N  165 N  165 N 
Bending Runout 
Load to 5 Mc (N) 
Performance Criteria Source: Criteria are based on aggregated mechanical testing data 
submitted to FDA in 510(k) submissions for spinal plating systems previously found to 
be substantially equivalent. 
Additional Considerations: Fatigue testing should include a minimum of 6 samples 
with at least two runouts at the highest established runout load and at least one failure. 
Fatigue precision (the ratio of the lowest failure load to the highest established runout) 
should meet the level specified in ASTM F1717. For testing of 1-level thoracolumbar 
plates, active length for the worst case should fall between 25 and 40 mm to be 
comparable to the criteria listed in the table above. 
Submission Information: Results summary and DoC 
Sterilization (devices labeled as sterile) and Reprocessing (end-user sterilized) Validation 
4.  Test name: Sterilization (devices labeled as sterile) and Reprocessing (end-user 
sterilized) 
Methodology: FDA currently-recognized versions 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 
6 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. 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. 
Performance Criteria Source: FDAs guidance: 
  Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile10
  Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling11
Submission Information: If using an Established Category A sterilization method, you 
should provide the information described in Section V.A. as specified in the FDA 
guidance Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile; 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 Center for Devices and Radiological Healths (CDRH) 
guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices  
Part 1: Evaluation and testing within a risk management process,12 referred to in the rest of this 
document as the CDRH Biocompatibility Guidance for brevity. FDA considers the devices 
covered by this guidance to be categorized as Implant Devices in contact with tissue/bone with a 
permanent contact duration of > 30 days and you should assess the endpoints below per 
Attachment A of the CDRH Biocompatibility Guidance. 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
  Acute Systemic Toxicity 
  Material-Mediated Pyrogenicity 
  Sub-acute/Sub-chronic Toxicity 
  Genotoxicity 
                                                
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled 
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-
devices-health-care-settings-validation-methods-and-labeling 
12 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 
7 Contains Nonbinding Recommendations 
  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 CDRH Biocompatibility Guidance is 
also provided. 
Testing: In rare cases, if you determined that testing is needed to address some or all of the 
identified biocompatibility 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, per Attachment E of the CDRH 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, resulting in the 
need for submission of a Traditional, Special, or Abbreviated 510(k). 
5.  Test name: Biocompatibility endpoints (identified from CDRH Biocompatibility 
Guidance) 
Methodology: FDA currently-recognized versions of biocompatibility consensus 
standards 
Performance Criteria: All direct or indirect tissue contacting components of the device 
and device-specific instruments should be determined to have an acceptable biological 
response. 
Performance Criteria Source: The CDRH 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 acceptable under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the CDRH Biocompatibility 
Guidance. For standard biocompatibility test methods that include comparison device 
control samples, the legally marketed comparison device control samples should perform 
as expected, as specified above for the subject device samples. 
Submission Information: Refer to CDRH Biocompatibility Guidance 
8