Bone Anchors - Premarket Notification (510(k)) Submissions | FDA

Bone Anchors - Premarket Notification (510(k)) Submissions | FDA

FDA Issues Final Guidance on Bone Anchor 510(k) Submissions

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Bone Anchors - Premarket Notification (510(k)) Submissions. The guidance is intended to help manufacturers evaluate their bone anchors (also called suture anchors).

Read the Guidance Facts about the final guidance The final guidance: Clarifies and provides the FDA’s current thinking on the recommended content for a bone anchor 510(k) submission, including: Performance testing recommendations and device description Relevant bench testing methods for bone anchor devices, including nitinol and absorbable polymeric bone anchors  Applies only to devices that attach soft tissue, such as tendons and ligaments, to bone. Anchors that attach bone-to-bone, have interference screw components, and anchors used with artificial ligaments or tendons are outside the scope of this guidance.   Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.