FDA Issues Final Guidance on Bone Anchor 510(k) Submissions
On 2nd March 2020, FDA issues Final Guidance on Bone Anchor – Premarket Notification 510(k) Submissions.
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.
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.