4.5mm Healix Advance Br Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5mm Healix Advance Br Anchor, with 2 or 3
by Depuy Mitek, A Johnson & Johnson Company
510(k) K133794
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133794 | Date4 Feb 2014 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- MAI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Healix Advance BR Anchor is a biodegradable soft tissue fixation device designed as a suture anchor for orthopedic applications. These anchors are intended to secure soft tissue, such as tendons or ligaments, to bone, providing stable fixation during procedures like rotator cuff repairs. Constructed with a bioabsorbable material, the anchors gradually degrade over time while maintaining mechanical integrity, eliminating the need for removal. The device features a bioabsorbable polymer body with a threaded design for secure placement in cortical bone, ensuring reliable fixation during the healing process.
The Healix Advance BR Anchor is supplied sterile and intended for single-use. Available in two sizes—4.5mm and 5.5mm—each anchor is preloaded with 2 or 3 strands of #2 Permacord suture, which is designed to minimize bulk and abrasion while maintaining compression. These anchors are classified as Class II devices under FDA regulations and have received FDA 510K clearance as substantially equivalent to predicate devices. They are intended for use in orthopedic settings, such as operating rooms, and must be stored in a dry, sterile environment as specified by the manufacturer.
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Questions
AI-generated answers, 1 Oct 2026
What is the Healix Advance BR Anchor used for?
The Healix Advance BR Anchor is designed for orthopedic applications to secure soft tissues, such as tendons or ligaments, to bone. It is particularly useful in procedures like rotator cuff repairs, where stable fixation is critical during the healing process. The biodegradable material ensures the anchor gradually degrades over time, eliminating the need for removal.
How is the Healix Advance BR Anchor supplied, and is it sterile?
The Healix Advance BR Anchor is supplied sterile and intended for single-use only. This ensures optimal safety and sterility for surgical procedures, reducing the risk of infection or contamination. Each package is designed to maintain sterility until use.
What sizes are available for the Healix Advance BR Anchor, and how many suture strands come preloaded?
The Healix Advance BR Anchor is available in two sizes: 4.5mm and 5.5mm. Each anchor is preloaded with either 2 or 3 strands of #2 Permacord suture, which is designed to minimize bulk and abrasion while maintaining compression during fixation.
How should the Healix Advance BR Anchor be stored?
The device must be stored in a dry, sterile environment as specified by the manufacturer. Proper storage ensures the integrity of the anchor and the sterility of the suture strands, which are critical for successful surgical outcomes.
Is the Healix Advance BR Anchor reusable, or is it intended for single-use?
The Healix Advance BR Anchor is explicitly intended for single-use only. This design choice aligns with best practices for medical devices to prevent cross-contamination and ensure patient safety, particularly in sterile surgical environments.