Docket Number:
FDA-2016-D-4436
Issued by:
Guidance Issuing Office
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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