Bio-Composite Suture Anchors: PushLock, Tak, Corkscrew
510(k) K082810
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082810 | Date23 Jan 2009 | 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- Withdrawn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
- Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew
- 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 Bio-Composite Suture Anchors (PushLock, Tak, Corkscrew) are biodegradable soft tissue fixation devices designed for orthopedic applications. These anchors provide secure attachment of soft tissue to bone using bio-absorbable composite materials, specifically PLLA/TCP or PLDLA/TCP. They are engineered as either screw-in or push-in types, with or without integrated suture eyelets, to facilitate knotless fixation. The anchors are categorized as fasteners for soft tissue fixation under regulatory classifications.
These anchors are intended for single-use in orthopedic procedures and are supplied in sterile packaging. The PushLock, Tak, and Corkscrew variants are designed for specific soft tissue repair applications, accommodating sutures or suture tapes. They are classified as Class II devices under FDA regulations and have received 510(k) clearance through a traditional review pathway, with a decision code of SESE (Substantially Equivalent). Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.
Other devices from Arthrex, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Arthrex Bio-Composite Suture Anchors used for?
The Bio-Composite Suture Anchors (PushLock, Tak, and Corkscrew) are designed for orthopedic applications to securely attach soft tissue to bone. They use biodegradable composite materials—PLLA/TCP or PLDLA/TCP—to provide reliable fixation without the need for traditional knot-tying. These anchors are ideal for procedures requiring stable soft tissue-to-bone repair, such as rotator cuff or ligament reconstructions.
How are the Bio-Composite Suture Anchors supplied, and are they sterile?
The anchors are supplied in sterile packaging, ensuring they meet medical device sterility standards before use. Each anchor is intended for single-use only, so unopened packaging must remain intact to maintain sterility. The sterile barrier prevents contamination, making them ready for immediate use in surgical settings.
Are these anchors reusable, or are they meant for one-time use?
These anchors are explicitly designed for single-use only. Their biodegradable composition and sterile packaging are optimized for one-time surgical application. Reusing them would compromise sterility, structural integrity, and patient safety, so adherence to single-use guidelines is critical.
What materials are used in the Bio-Composite Suture Anchors, and how do they degrade?
The anchors incorporate bio-absorbable composite materials: either PLLA/TCP (poly-L-lactic acid/tricalcium phosphate) or PLDLA/TCP (poly-D,L-lactic acid/tricalcium phosphate). These materials gradually degrade over time in the body, eliminating the need for removal. The degradation process supports natural tissue integration while maintaining fixation stability during the healing phase.
How should these anchors be stored before use?
Storage must follow sterile medical device protocols to preserve integrity. Keep the anchors in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise sterility or material properties before surgery.