Bio Mini-Revo Suture Anchor
510(k) K072291
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072291 | Date14 Jul 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Conmed Linvatec Bio Mini-Revo Suture Anchor
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Bio Mini-Revo Suture Anchor is a bioabsorbable orthopedic device classified as a suture anchor (product code HWC). It is designed for securing soft tissue to bone, providing a secure fixation point for procedures such as labral repair in arthroscopic or open surgeries. Constructed from bioabsorbable materials, it offers controlled degradation while maintaining mechanical stability during the healing process. Its low-profile design facilitates precise placement, reducing the risk of impingement or displacement.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510K clearance (K072291) and falls under the Orthopedic advisory committee classification. The kit includes drill guides, a drill bit, a bone punch, and a self-drilling tap to assist in accurate implant positioning. Storage requires adherence to sterile packaging instructions, and its bioabsorbable composition ensures gradual resorption post-implantation without the need for removal.