Contains Nonbinding Recommendations 
Bone Anchors - Premarket 
Notification (510(k)) Submissions 
Guidance for Industry and Food and 
Drug Administration Staff 
Document issued on March 3, 2020. 
The draft of this document was issued on January 3, 2017. 
  
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  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-2016-D-4436. 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 1400005 and complete title of the guidance in the request.  Contains Nonbinding Recommendations 
Table of Contents
 
I.  INTRODUCTION .................................................................................................................................... 1 
II.  SCOPE ....................................................................................................................................................... 2 
III.  510(K) SUBMISSION RECOMMENDATIONS ................................................................................... 2 
A. DEVICE DESCRIPTION .................................................................................................................................. 2 
1.  General Suture Anchors ................................................................................................................. 2 
2.  Nitinol Suture Anchors .................................................................................................................. 3 
3.  Polymeric Absorbable Suture Anchors .......................................................................................... 4 
B.  PREDICATE COMPARISON ............................................................................................................................ 4 
C.  BIOCOMPATIBILITY ...................................................................................................................................... 5 
D. STERILITY .................................................................................................................................................... 7 
E.  REPROCESSING (INCLUDING SINGLE-USE DEVICES PROVIDED NON-STERILE AND INTENDED FOR STERILE 
PROCESSING) ................................................................................................................................................ 7 
F.  PYROGENICITY ............................................................................................................................................ 8 
G. SHELF LIFE AND PACKAGING ....................................................................................................................... 8 
H. MAGNETIC RESONANCE (MR) COMPATIBILITY FOR PASSIVE IMPLANTS ..................................................... 9 
I.  NON-CLINICAL PERFORMANCE TESTING ................................................................................................... 10 
1.  Suture Characterization ............................................................................................................... 10 
2.  Insertion Testing .......................................................................................................................... 11 
3.  Pullout Testing ............................................................................................................................. 11 
4.  Component Interconnection Testing ............................................................................................ 12 
5.  Fatigue Testing ............................................................................................................................ 12 
6.  Corrosion ..................................................................................................................................... 12 
7.  Degradation Testing..................................................................................................................... 13 
J.  CLINICAL PERFORMANCE TESTING ............................................................................................................ 15 
K. LABELING .................................................................................................................................................. 16 
L.  MODIFICATIONS (DEVICES SUBJECT TO 510(K)) ........................................................................................ 17  Contains Nonbinding Recommendations 
Bone Anchors - Premarket 
Notification (510(k)) Submissions 
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 document provides recommendations for 510(k) submissions for bone anchor 
(suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This 
final guidance clarifies and provides current thinking on the recommended content for a bone 
anchor 510(k) submission, including performance testing recommendations and device 
description. Specifically, this guidance reflects the most current thinking on relevant bench 
testing methods for bone anchor devices including nitinol and absorbable polymeric bone 
anchors. 
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database.1 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.2
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. 
                                                
1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
2 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 
This guidance document is intended to address the relevant descriptive characteristics, labeling, 
biocompatibility, and bench testing related to the premarket notification (510(k)) review of 
bone anchor (suture anchor) devices used in the appendicular skeleton for attachment of soft 
tissue to bone. This attachment may be achieved by attaching one end of a suture to the soft 
tissue and the other end to a device that is inserted into the bone. This document does not 
address anchors used to attach bone to bone, or interference screw components, nor does it 
address anchors intended for use with artificial ligaments or tendons. 
These devices are classified under 21 CFR 888.3030 and 21 CFR 888.3040 and with the 
product codes listed in the table below: 
Product Code  Product Code Name  Regulation Number 
MAI  Fastener, fixation, biodegradable, soft tissue  21 CFR 888.3030 
MBI  Fastener, fixation, nondegradable, soft tissue  21 CFR 888.3040 
Please note that suture anchor devices may have historically been cleared with other product 
codes (e.g., HWC); however, these product codes are more appropriate for other orthopedic 
devices (e.g., fixation screws). To ensure that the product code clearly reflects the intended 
device type (i.e., bone anchor), we recommend that future submissions be submitted under the 
product codes MAI or MBI.  For determination of substantial equivalence, predicate suture 
anchors cleared under other product codes may be used. 
III.  510(k) Submission Recommendations 
A.  Device Description 
We recommend you identify your device by the applicable regulation number and product code 
indicated in Section II above and include the information described below. 
1.  General Suture Anchors 
a.  Bone anchor dimensions (e.g., length, inner/outer diameter) and material 
(including applicable material standards, if any) should be provided.  We 
recommend you provide drawings or figures for all device components with 
relevant dimensions labeled. 
b.  If there are multiple bone anchor components (e.g., an inner component and 
outer sleeve), you should provide a description of how the components are 
assembled. 
c.  If a suture is included with the anchor construct (e.g., preloaded with the anchor 
on an inserter), you should provide the identity and percentages of all materials 
2 Contains Nonbinding Recommendations 
(including coatings and additives) and the sizes of sutures using the size system 
identified in the currently recognized United States Pharmacopoeia (USP). For 
more details on the information to be included with a suture component, please 
refer to the FDA guidance document, Class II Special Controls Guidance 
Document: Surgical Sutures.3 If the suture has been previously cleared by the 
Agency, you should identify the submission number (e.g., 510(k) number) and 
provide a statement that the suture is identical to that cleared under the previous 
510(k) or clearly document any changes introduced to the cleared suture. 
d.  A description of the suture/anchor attachment mechanism (e.g., suture tied to an 
eyelet on the distal end of the anchor) should be provided. 
e.  Some anchor constructs are intended for use with a suture to be determined by 
the end user. If the anchor system does not include a suture, but is intended for 
use with a generic suture of a specific size, you should ensure that the 
recommended suture size (e.g., USP size 2) and type (i.e., absorbable vs. non-
absorbable) is specified in the submission and the draft labeling. 
f.  If the anchor is intended to be used as part of a system with device-specific 
instrumentation, a description of all compatible components (e.g., suture anchor 
driver, anchor device, and suture) should be provided. 
g.  You should provide the method of bone preparation for insertion of the anchor 
(e.g., self-tapping, or pilot hole diameter and depth). 
The recommended descriptive characteristics listed above are meant to cover all suture anchor 
components. The additional nitinol and absorbable information discussed below should be 
provided, if applicable, in addition to the general information discussed above. 
2.  Nitinol Suture Anchors 
a.  A description of conformance to any applicable material standard (e.g., ASTM 
F2063: Standard Specification for Wrought Nickel-Titanium Shape Memory 
Alloys for Medical Devices and Surgical Implants) should be provided. 
b.  If there are no applicable standards for your material, you should provide the 
chemical composition. You should also describe the mode of action (e.g., thermal 
shape memory or superelasticity) by which the suture anchor transitions to the 
specified size and shape. 
c.  The transition temperatures (i.e., A  and A) of your final, finished device using 
s f
samples from multiple production lots should be provided. We recommend using 
the methods described in ASTM F2004: Standard Test Method for 
Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis, 
                                                
3 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/surgical-sutures-class-ii-special-controls-guidance-document-industry-and-fda-staff. 
3 Contains Nonbinding Recommendations 
ASTM F2082: Standard Test Method for Determination of Transformation 
Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free 
Recovery, or an equivalent method. You should provide specifications for the 
acceptable A temperature range for your suture anchor. 
f
d.  You should provide a description of the final processing, including surface 
treatment processes (e.g., shape setting, polishing, and/or passivation steps) 
performed on your nitinol suture anchor (including any electro-polishing and/or 
passivation steps). 
3.  Polymeric Absorbable Suture Anchors 
a.  The material of construction and any applicable consensus standards to which it 
conforms should be provided. If the identical material was used in a predicate 
anchor, you should specify the 510(k) number for this predicate. 
b.  A description of the as-manufactured analytical properties of your device (e.g., 
molecular weight, residual monomer content, and crystallinity) should be 
provided. 
c.  The degradation mechanism (e.g., hydrolysis) should be provided. 
d.  The degradation profile over time should be provided. 
Absorbable suture anchor components typically consist of hydrolytically degradable polymers 
(e.g., poly-L-lactide (PLLA)). Suture anchors that consist of other material types, or with another 
mechanism of degradation, would likely warrant additional types of information. 
B.  Predicate Comparison 
For devices reviewed under the 510(k) process, manufacturers must compare their new device to 
a similar legally marketed predicate device to support its substantial equivalence (section 513(i) 
(21 U.S.C. 360c(i)) of the FD&C Act; 21 CFR 807.87(f)). This comparison should provide 
information to show how your device is similar to and different from the predicate. Side by side 
comparisons, whenever possible, are desirable. See below for an example of how this 
information may be organized.  This table is not intended to represent an exhaustive list of 
comparative parameters; ensure you provide all relevant device descriptive characteristics as 
outlined in the Device Description section, above. 
4 Contains Nonbinding Recommendations 
Table 1  Sample predicate comparison table to outline differences and similarities 
between the subject and predicate devices 
Description  Subject Device  Predicate Device (Kxxxxxx) 
Indications For Use 
Anchor Geometry 
Anchor Dimensions 
(inner/outer diameters) 
Anchor Material 
Range of Suture Diameter 
Method of Fixation of Suture 
to Anchor 
Other Relevant 
Characteristics 
C. Biocompatibility
Significance: Bone anchors contain patient-contacting materials, which, when used for their 
intended purpose (i.e., contact type and duration), may induce a harmful biological response.  
Recommendation: You should determine the biocompatibility of all patient-contacting materials 
present in your device (including the anchor and associated suture). If your device is identical in 
composition and processing methods to bone anchors with a history of successful use, you may 
reference previous testing experience or peer-reviewed literature, if appropriate. For some device 
materials, it may be appropriate to provide a reference to either a recognized consensus standard, 
or to a Letter of Authorization (LOA) for a device Master File (MAF). You should refer to the 
following FDA webpage for additional information on using device MAFs: 
https://www.fda.gov/medical-devices/premarket-approval-pma/master-files. 
If you are unable to identify a legally marketed predicate device with similar location/duration of 
contact and intended use that uses the same materials as used in your device, we recommend you 
conduct and provide a biocompatibility risk assessment. The assessment should explain the 
relationship between the identified biocompatibility risks, the information available to mitigate 
the identified risks, and any knowledge gaps that remain. Your risk assessment can include 
specifications of the incoming raw material and a description of the processing and/or 
sterilization of the final device. You should then identify any biocompatibility testing or other 
evaluations that were conducted to mitigate any remaining risks. 
We recommend that you follow FDAs guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 
5 Contains Nonbinding Recommendations 
management process,4 which identifies the types of biocompatibility assessments that should 
be considered and recommendations regarding how to conduct related tests. 
Per ISO 10993-1: Biological evaluation of medical devices  Part 1: Evaluation and testing 
within a risk management process and Attachment A of FDAs guidance on ISO 10993-1, bone 
anchors are considered implant devices in contact with tissue/bone for a permanent contact 
duration. Therefore, the following endpoints should be addressed in your biocompatibility 
evaluation: 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
  Acute Systemic Toxicity 
  Material-Mediated Pyrogenicity 
  Subchronic toxicity (Sub-acute toxicity) 
  Genotoxicity (We recommend that both mutagenicity and clastogenicity be assessed.) 
  Implantation 
  Chronic Toxicity 
  Carcinogenicity 
For patient-contacting device-specific instrumentation (e.g., inserter shafts) in contact with 
tissue/bone for a temporary contact duration, the following endpoints should be addressed in 
your biocompatibility evaluation: 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
  Acute Systemic Toxicity 
  Material-Mediated Pyrogenicity 
The following additional considerations are recommended for bone anchors: 
  If the suture component includes a coating, this coating should be evaluated for 
biocompatibility as part of the final, finished, sterilized device per ISO 10993-1. 
  If your biocompatibility assessment relies on the use of raw materials, you should ensure 
that you address the subsequent processing, cleaning, and sterilization steps to address 
the biocompatibility of the final sterilized device. 
                                                
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
6 Contains Nonbinding Recommendations 
  Differences in formulation, processing, sterilization, or device surface properties (e.g., 
nanostructuring) that could affect biocompatibility of the final product may warrant 
additional biocompatibility testing. 
  For new formulations of degradable anchors (e.g., new combinations of degradable 
materials, new additives), in addition to the testing described above, we recommend you 
address the biocompatibility of the anchor over the life of the implant (i.e., the time 
required for healing of the soft tissues being repaired) and discuss the starting, 
intermediate, and final degradation products present over the course of degradation.  This 
testing should be conducted in accordance with ISO 10993-9: Biological evaluation of 
medical devices  Part 9: Framework for identification and quantification of potential 
degradation products. 
D.  Sterility 
Significance: Bone anchors are implanted devices and should be adequately sterilized to 
minimize infections and related complications.  
Recommendation: For bone anchors labeled as sterile, we recommend that you provide 
information for the finished device in accordance with FDAs guidance Submission and Review 
of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as 
Sterile.5
E.  Reprocessing (including single-use devices provided non-
sterile and intended for sterile processing) 
Significance: Many of the patient contacting components of bone anchor instrumentation are 
reused, and should be adequately cleaned, disinfected, and sterilized between uses to minimize 
infections and prevent device degradation. 
Recommendation: Instructions on how to reprocess a reusable device, or a single-use device that 
is provided non-sterile to the user, are critical to ensure that a device is appropriately prepared 
for its initial and subsequent uses. For recommendations regarding the development and 
validation of reprocessing instructions in your proposed device labeling, please refer to FDAs 
guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling.6
                                                
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling. 
7 Contains Nonbinding Recommendations 
F.  Pyrogenicity 
Significance: Pyrogenicity testing is used to help protect patients from the risk of febrile reaction 
due to gram-negative bacterial endotoxins and/or chemicals that can leach from a medical device 
(e.g., material-mediated pyrogens). 
 
Recommendation: To address the risks associated with the presence of bacterial endotoxins, 
bone anchors should meet pyrogen limit specifications by following the recommendations 
outlined in FDAs guidance Submission and Review of Sterility Information in Premarket 
Notification (510(k)) Submissions for Devices Labeled as Sterile.7 You should also follow the 
recommendations in Pyrogen and Endotoxins Testing: Questions and Answers.8 To address 
the risks associated with material-mediated endotoxins, follow the recommendations in FDAs 
guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices 
- Part 1: Evaluation and testing within a risk management process.9
For devices intended to be labeled as non-pyrogenic, we recommend that both bacterial 
endotoxin and material-mediated pyrogen testing be conducted. 
G.  Shelf Life and Packaging 
Significance: Shelf-life testing is conducted to support the proposed expiration date through 
evaluation of the package integrity for maintaining device sterility and/or evaluation of any 
changes to device performance or functionality. 
Recommendation: With respect to package integrity for maintaining device sterility, you should 
provide a description of the packaging, including how it will maintain the devices sterility, and 
a description of the package integrity test methods used, but not the package test data. We 
recommend that a package validation study include simulated distribution and associated 
package integrity testing, as well as an aging process (accelerated and/or real-time) and 
associated seal strength testing, to validate package integrity and shelf-life claims. We 
recommend you follow the methods described in the FDA-recognized series of consensus 
standards, ANSI/AAMI/ISO 11607-1: Packaging for terminally sterilized medical devices  Part 
1: Requirements for materials, sterile barrier systems and packaging and ANSI/AAMI/ISO 
11607-2: Packaging for terminally sterilized medical devices  Part 2: Validation requirements 
for forming, sealing and assembly processes. Since many absorbable materials will be sensitive 
to moisture and temperature, we recommend that your packaging description and testing address 
these important considerations for any absorbable device. 
                                                
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-
questions-and-answers. 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
8 Contains Nonbinding Recommendations 
With respect to evaluating the effects of aging on device performance or functionality, shelf-life 
studies should evaluate the critical physical and mechanical properties to ensure it will perform 
adequately and consistently during the entire proposed shelf life. To evaluate device 
functionality, we recommend that you assess each of the bench tests described below in Section 
III.I, Non-Clinical Performance Testing, and repeat all tests that evaluate design components or 
characteristics that may be potentially affected by aging using aged devices. 
We recommend that you provide a summary of the test methods used for your shelf life testing, 
results, and the conclusions drawn from your results. If you use devices subject to accelerated 
aging for shelf-life testing, we recommend that you specify the way in which the devices were 
aged and provide a rationale to explain how the results of shelf life testing based on accelerated 
aging are representative of the results if the device were aged in real time. We recommend that 
you age your devices as per the currently FDA-recognized version of ASTM F1980: Standard 
Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and specify the 
environmental parameters established to attain the expiration date. The shelf life of the device 
should correspond to the duration of aging completed and submitted prior to 510(k) clearance. 
For devices or components containing polymeric materials or coatings, you should conduct 
testing on real-time aged samples to confirm the results of the accelerated aging study. This 
testing should be conducted in parallel with 510(k) review and clearance, with results 
documented to file in the design history file (i.e., the test reports do not need to be submitted to 
FDA). 
H.  Magnetic Resonance (MR) Compatibility for Passive 
Implants 
Significance: MR imaging of patients with bone anchors poses the following potential hazards: 
  movement of the implant, resulting in tissue damage or displacement of the bone anchor, 
  heating of the tissue surrounding the implant and subsequent tissue damage, and 
  image artifacts that may render the MR images uninterpretable or misleading. 
Recommendation: We recommend that you address the issues affecting safety and compatibility 
of your device (including the anchor and associated suture) in the MR environment as described 
in FDAs guidance Establishing Safety and Compatibility of Passive Implants in the Magnetic 
Resonance (MR) Environment.10
If you would like to market bone anchors of various sizes and shapes, then we recommend you 
follow our recommendations in the FDA guidance Assessment of Radiofrequency-Induced 
Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical 
Devices.11
                                                
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-safety-and-
compatibility-passive-implants-magnetic-resonance-mr-environment. 
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessment-radiofrequency-
induced-heating-magnetic-resonance-mr-environment-multi-configuration. 
9 Contains Nonbinding Recommendations 
I.  Non-Clinical Performance Testing 
FDA recommends that you evaluate the material and performance characteristics of your final, 
worst-case, sterilized device (including the anchor and associated suture) for the subsections 
below. If suture components are provided sterile and must be industrially resterilized with the 
suture anchor, you should provide a robust rationale that addresses why the resterilization is not 
expected to affect the performance of the suture component. Bench testing should assess 
implantation of the device using the surgical technique identified in the labeling, including any 
device specific instrumentation. 
While there is no minimum acceptable sample size for testing, a sample size of five (5) units has 
historically been accepted as the minimum for bench testing. Additional issues in testing (e.g., 
large variability in results) or device design may indicate that a sample size beyond this 
minimum is recommended. 
It is recommended that all testing include comparison to a predicate with equivalent indications 
for use to the subject bone anchor system; however, a comparison to worst-case clinical loading 
on the device may be sufficient to evaluate the performance of a suture anchor and establish 
equivalence. If a comparison to clinical loading is provided, we recommend that you provide a 
robust, clinically-based justification of the loads used (such as peer-reviewed literature citations 
where relevant). 
For information on the recommended content and format of test reports for the testing described 
in this section, refer to FDAs guidance, Recommended Content and Format of Non-Clinical 
Bench Performance Testing in Premarket Submissions.12
1.  Suture Characterization 
Significance: Inadequate suture strength can lead to premature failure of the anchor 
during implantation or clinical use. 
Requirement: You must13 provide information to demonstrate that the special 
controls identified in sections 7-11 of FDAs guidance document, Class II Special 
Controls Guidance Document: Surgical Sutures14 have been adequately addressed.  
If the suture has been previously cleared in a predicate submission, this submission 
may be referenced in lieu of suture characterization along with a scientific rationale 
for why suture performance (e.g. USP requirements, degradation profile) is 
unchanged by the suture anchor manufacturing processes (e.g., incorporation into 
the anchor construct and sterilization).  If the manufacturing process of the suture 
                                                
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket. 
13 See section 513(a)(1)(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act). 
14 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/surgical-sutures-class-ii-special-controls-guidance-document-industry-and-fda-staff. 
10 Contains Nonbinding Recommendations 
anchor could potentially affect the performance of a previously cleared suture (e.g., 
re-sterilization or use of a different sterilization method from the cleared suture), 
additional data may be needed to support the suture's performance. 
2.  Insertion Testing 
Significance: Insertion into dense bone can cause failure of the bone anchor. An 
evaluation of worst-case insertion provides assurance of adequate insertion strength 
of the anchor and associated insertion instrumentation. 
Recommendation: Insertion testing should be conducted in the worst-case bone or 
bone substitute based on the anatomic locations in the indications for use. If a bone 
substitute is used, we recommend that it conform to ASTM F1839: Standard 
Specification for Rigid Polyurethane Foam for Use as a Standard Material for 
Testing Orthopaedic Devices and Instruments. The worst-case for insertion should 
evaluate the ability of the anchor to be deployed correctly and without damage to 
the device. It may be acceptable to show that the device has been deployed 
undamaged by evaluating fixation/pullout strength if the pullout testing utilizes the 
worst-case test set-up for insertion failure mode. Although this is typically 
performed in more dense bone, if there is concern that an anchor design may not 
successfully deploy in less dense bone, this scenario should also be evaluated. 
Testing should be performed in accordance with the steps described in the surgical 
technique (e.g., pilot hole preparation). 
Example: For bone anchors indicated for use in the hip, we recommend that you 
provide insertion testing that simulates the hard cortical bone of the hip. While it is 
the responsibility of the submitter to provide a rationale for an acceptable test setup, 
we recommend testing in a dense bone substitute per ASTM F1839 (e.g., 40 pound 
per cubic foot (PCF) foam). If another test setup is used to evaluate the insertion of 
anchors with hip indications, you should provide a rationale for the acceptability of 
the insertion construct. 
3.  Pullout Testing 
Significance: Bone anchors subjected to a tensile load may fail by pullout from the 
bone or breakage of the anchor or suture. 
Recommendation: Pullout testing should be conducted in the worst-case bone or 
bone substitute based on the anatomic locations of the indications for use. Note that 
the failure point of the bone anchor may be the suture itself, the suture/anchor 
interface, or the anchor/bone interface. The prevalence of these various failure 
modes may be affected by the density of the test substrate. Although there is no 
single accepted value for testing, we recommend testing at a middle range of 
density (e.g., 20 PCF per ASTM F1839); however, this density may not be 
appropriate for all designs and indications. We recommend you provide a robust 
rationale as to your choice of bone or bone substitute based on the indications for 
use and technological characteristics (i.e., likely failure modes) of the bone anchor.
11 Contains Nonbinding Recommendations 
For certain suture anchor designs, testing in ambient air may be appropriate; 
however, some devices (e.g., nitinol) may be affected by testing conditions (e.g., 
testing temperature, testing immersed in saline), so it is recommended that the test 
setup take these factors into account when appropriate. 
4.  Component Interconnection Testing 
Significance: Bone anchors can be assembled from multiple components that may 
fail in a different manner than insertion or pullout. 
Recommendation: If a bone anchor is assembled from multiple components (e.g., 
two pieces that are screwed together), interconnection strength between 
components should be evaluated and compared against worst-case expected loading 
or a legally marketed predicate device. 
5.  Fatigue Testing 
Significance: Bone anchor components subjected to cyclic loading may experience 
failure of the anchor construct due to suture fray or fatigue failure of the anchor 
component. 
Recommendation: If the anchor is expected to experience cyclic loading (i.e., 
healing time exceeds the time the anatomic location is immobilized post-
surgically), it is recommended that you conduct fatigue testing to address the 
concern of bone anchor fixation failure. We recommend that you provide a robust 
clinical rationale (e.g., peer-reviewed clinical literature) to support a decision that 
fatigue testing is not necessary for the specific indications. Additionally, if the 
anchor design is novel and may present a new worst-case for cyclic failure (e.g., 
presence of a new stress riser at the suture connection point), fatigue testing is 
recommended regardless of the expected healing time. 
We recommend that you conduct comparative (side-by-side testing with predicate 
or with historical data) cyclic testing with a clinically justified load and cycle 
number. We further recommend you conduct pullout testing following cyclic 
loading to demonstrate that pullout strength is retained in a worst-case clinical 
healing scenario. If historical data are used for comparison, we recommend that 
fatigue testing acceptance criteria and test set-up parameters be supported. 
6.  Corrosion 
Significance: Metallic bone anchor materials, including nitinol, may experience 
surface corrosion and subsequent release of ions due to electrochemical interactions 
occurring in the body. 
Recommendation: An evaluation of the breakdown pitting corrosion potential of 
your suture anchor should be provided. It is recommended that this evaluation be 
performed according to ASTM F2129: Standard Test Method for Conducting 
Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion
12 Contains Nonbinding Recommendations 
Susceptibility of Small Implant Devices. In this evaluation, we recommend you 
address the following: 
  Test devices should be representative of final sterilized devices and selected 
such that potential variations due to manufacturing can be assessed (e.g., testing 
samples from multiple lots). 
  The worst-case implant component should be used to assess corrosion 
resistance. Considerations should be given to factors such as geometry or size 
that may affect surface finishing such as adequate polishing of regions of high 
curvature. 
  Test reports for pitting corrosion potential testing should be consistent with 
ASTM F2129. For example, test reports should include corrosion/rest 
potentials, breakdown potentials, as well as polarization curves. When practical, 
we recommend that you plot all polarization curves in one graph. You should 
ensure that you discuss any deviations from the ASTM F2129 standard (e.g., 
test setup not meeting the criteria outlined in ASTM G5: Standard Reference 
Test Method for Making Potentiodynamic Anodic Polarization Measurements). 
  Results should be assessed against your acceptance criteria. The acceptance 
criteria for the pitting corrosion testing should be determined by comparison to 
a legally marketed predicate device with good clinical history of use (i.e., no 
history of corrosion-related fractures or adverse events associated with nickel 
release). Alternatively, while there is a paucity of data directly linking in vitro 
corrosion testing to in vivo corrosion outcomes, conservative guidelines have 
been published by Corbett (2004),15 which may also be used to establish 
acceptance criteria. 
  If breakdown occurred, you should include results of the visual inspection of 
your device before and after testing to assess evidence of pitting. Images of 
sufficient magnification should be included to support these observations and 
identify pit locations. 
Based on the device design, pitting corrosion evaluation, and surface finishing 
information, further corrosion testing (e.g., metal ion release) and/or surface 
characterization analyses may be recommended. 
7.  Degradation Testing 
Significance: Anchors composed of degradable polymers lose their structural and 
mechanical properties over time as they degrade, which may lead to insufficient 
mechanical properties if degradation occurs too rapidly. 
                                                
15 Corbett, R.A. Laboratory Corrosion Testing of Medical Implants In: Shrivastava S, editor. Proc. Materials and 
Processes for Medical Devices Conf., Materials Park, OH: ASM International; 2004. p. 166-171. 
13 Contains Nonbinding Recommendations 
Recommendation: We recommend providing an evaluation of the degradation of 
anchor components consistent with the methods outlined in: 
  ASTM F1635: Standard Test Method for in vitro Degradation Testing of 
Hydrolytically Degradable Polymer Resins and Fabricated Forms for 
Surgical Implants, 
  ISO 13781: Implants for surgery  Homopolymers, copolymers and blends 
on poly(lactide)  In vitro degradation testing, and 
  ASTM F2502: Standard Specification and Test Methods for Absorbable 
Plates and Screws for Internal Fixation Implants. 
For mechanical evaluation of degradable anchors, we recommend that you apply an 
appropriately justified load to the anchor during testing. Furthermore, it is 
recommended that degradation testing be performed in an appropriate worst-case 
bone substitute. 
Also, we recommend that the worst-case implant component configuration(s) be 
used to address degradation of mechanical properties. Multiple factors may affect 
the rate of degradation, including surface area to volume ratio, location of critical 
design features, etc., and the worst-case component may not be intuitive (i.e., may 
not be the smallest component size). A justification for the applied loading and 
worst-case component(s) selected should be provided. 
Bone anchors should be tested to at least twice the expected duration of healing. We 
recommend you compare the performance at time zero (0) and at multiple time 
points beyond (e.g., 3, 6, 12, 26 weeks).  At each time point, the peak pullout force 
should be compared to a legally marketed predicate with equivalent indications for 
use and technological characteristics or to pre-specified acceptance criteria and test 
set-up parameters based on clinically relevant historical data (e.g., published peer-
reviewed literature).  We further recommend that your test report for mechanical 
properties over time include the force-displacement curves acquired at each time 
point and a description of the failure mode observed.  Additional testing (e.g., 
fatigue testing) may also be requested based on device design and/or clinical use 
(indications, anatomical location). 
In addition to the mechanical characterization, it is recommended that you 
characterize device degradation (e.g., mass loss, changes in molar mass averages 
(number-average (M ) and mass-average (M ))) over the course of testing to more 
n w
fully characterize the degradation process. You should provide a detailed 
description of the methods used along with references to any applicable consensus 
standards followed. 
14 Contains Nonbinding Recommendations 
J.  Clinical Performance Testing 
Significance: In some cases, non-clinical evaluation does not fully characterize all clinical 
experience, outcomes, and risks. In such cases, we recommend that you conduct clinical studies 
to evaluate device safety and effectiveness for new and modified bone anchors. 
Recommendation: 
Clinical evidence is generally unnecessary for most bone anchors; however, such testing may be 
requested in situations such as the following: 
  indications for use dissimilar (e.g., different anatomical location of use) from legally 
marketed devices of the same type that would not constitute a new intended use, 
  new technology, i.e., technology different from that used in legally marketed devices of 
the same type that raise clinical performance questions, yet does not raise different 
questions of safety or effectiveness, 
  cases where engineering and/or animal testing16 raises issues that warrant further 
evaluation with clinical evidence, and/or 
  devices with lower mechanical properties (e.g., pullout strength) than predicates. 
We will consider alternatives to clinical testing when the proposed alternatives are supported by 
an adequate scientific rationale. If a clinical study is needed to demonstrate substantial 
equivalence, i.e., conducted prior to obtaining 510(k) clearance of the device, the study must be 
conducted under the Investigational Device Exemptions (IDE) regulation, 21 CFR 812. 
Generally, we believe bone anchors addressed by this guidance document are significant risk 
devices subject to all requirements of 21 CFR 812. See the FDA Guidance titled, Significant 
Risk and Nonsignificant Risk Medical Device Studies.17 In addition to the requirements of 21 
CFR 812, sponsors of such trials must comply with the regulations governing institutional 
review boards (21 CFR 56) and informed consent (21 CFR 50). 
When data from clinical investigations conducted outside the United States are submitted to 
FDA for these devices, the requirements of 21 CFR 812.28 may apply.18 21 CFR 812.28 outlines 
the conditions for FDA acceptance of clinical data from investigations conducted outside the US 
when submitted to support premarket submissions. For more information, see the FDA guidance
                                                
16 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible.  We 
encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
17 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-
risk-medical-device-studies. 
18 This applies to data from clinical investigations that began on or after February 21, 2019 and are submitted to 
support a premarket submission, including IDEs, premarket approval applications (PMAs), and 510(k)s. 
15 Contains Nonbinding Recommendations 
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: 
Frequently Asked Questions.19
In some cases, real-world data (RWD) may be used to support an expansion of the 
indication(s) for a device for which 510(k) clearance has already been obtained. Whether the 
collection of RWD for a legally-marketed device requires an IDE depends on the particular facts 
of the situation. Specifically, if a cleared device is being used in the normal course of medical 
practice, an IDE would likely not be required. For additional information regarding this topic, 
please refer to the FDA Guidance entitled Use of Real-World Evidence to Support Regulatory 
Decision-Making for Medical Devices.20
K.  Labeling 
The premarket notification must include proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e).  Proposed labels and labeling, sufficient to describe the bone 
anchor, its intended use, and the directions for use must be provided.  
 
As prescription devices, bone anchors are exempt from having adequate directions for lay use 
required under section 502(f)(1) of FD&C Act (21 U.S.C.  352(f)(1)) as long as the conditions 
in 21 CFR 801.109 are met.  For instance, labeling must include adequate information for 
intended user of the device, including indications, effects, routes, methods, frequency and 
duration of administration, and any relevant hazards, contraindications, side effects, and 
precautions (21 CFR 801.109(d)). 
The labeling should include the following information: 
Indications for Use 
These devices are intended for reattachment of soft tissue (e.g., ligament and tendon) to bone 
at various anatomic locations. Different designs of anchor are suited for use at varying 
anatomic locations; therefore, we recommend that the indications for use are sufficiently 
detailed to specify the anatomic locations for the anchor components. 
Directions for Use 
The directions for use should familiarize users trained in the target specialty (e.g., orthopedic 
surgeons) with the features of the device and how to use it in a safe and effective manner, 
including assembly and insertion of anchor components for all of the proposed indications. 
                                                
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-
medical-device-applications-and-submissions-frequently-asked. 
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices. 
16 Contains Nonbinding Recommendations 
L.  Modifications (Devices subject to 510(k)) 
In accordance with 21 CFR 807.81(a)(3), a device change or modification that could 
significantly affect the safety or effectiveness of the device or represents a major change or 
modification in the intended use of the device requires a new 510(k). The changes or 
modifications listed below would likely require submission of a new 510(k). Note that this list is 
not exhaustive but provides examples of modifications that will generally require submission of 
a new 510(k).  For additional details, please see the FDA guidance Deciding When to Submit a 
510(k) for a Change to an Existing Device.21
Such changes or modifications include: 
  The addition of a smaller or larger anchor diameter than what was previously cleared or 
the addition of a smaller suture size  FDA considers these changes to be a significant 
change in design. FDA has determined that these changes could significantly affect the 
safety and effectiveness of the device by introducing a new potential worst-case scenario 
for some failure modes. 
  A modification to the insertion technique (e.g., change from pre-drilled to self-punching) 
 FDA considers this change to be a significant change in design of the anchor or the 
instrumentation. FDA has determined that this change could significantly affect the 
safety and effectiveness of the device by altering the risk of adequate fixation. 
  The modification of the material formulation of a bone anchor or a change to a new 
material such as from a non-absorbable to absorbable suture  FDA considers these 
changes to be a significant modification in material, chemical composition, or material 
processing. FDA has determined that these changes could significantly affect the safety 
and effectiveness of the device by introducing new or increased biocompatibility 
concerns or a change in the risks associated with device failure. 
FDA believes that the following changes or modifications would likely not require submission of 
a new 510(k): 
  Addition of a suture anchor of identical design and material to a cleared anchor, but of an 
intermediate length (e.g., 15mm length anchor added to a system with 10mm and 20mm 
lengths), or an increase in the length of a suture anchor inserter handle because neither 
scenario would generally introduce new or significantly modified risks or new worst-case 
failure modes. 
                                                
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
change-existing-device. 
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