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GUIDANCE DOCUMENT

Premarket Notification (510(k)) Submissions for Bone Anchors Guidance for Industry and Food and Drug Administration Staff January 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Premarket Notification (510(k)) Submissions for Bone Anchors

Docket Number:
FDA-2016-D-4436
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides recommendations for 510(k) submissions for bone 13anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone.This guidance is issued for comment purposes only.

This draft guidance is a reissuance of the prior draft guidance “Guidance Document for Testing Bone Anchor Devices” dated April 20, 1996. FDA is updating this guidance to clarify and provide 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.


Submit Comments

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

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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