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# Guide on Bone Anchor 510(k) Submissions
- URL: https://www.fdaweb.com/guide-on-bone-anchor-510-k-submissions/
- Published: 2020-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:05:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146214

FDA has released a [final guidance](https://www.fda.gov/media/72235/download?ref=fdaweb.com) on “Bone Anchors — Premarket Notification (510(k))Submissions.” The document provides submission recommendations for bone anchor (suture anchor) devices, which are indicated for attaching soft tissue to bone. It clarifies and provides current thinking on performance testing recommendations and device descriptions. Additionally, it addressed relevant bench testing methods for bone anchor devices including nitinol and absorbable polymeric bone anchors.