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GUIDANCE DOCUMENT

Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff March 2020

Final
Docket Number:
FDA-2016-D-4436
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

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.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4436.