Stryker All Suture Anchors
by Stryker
510(k) K120509
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120509 | Date26 Jul 2012 | 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- Withdrawn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
- MBI
- 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 Stryker All-Suture Anchors are orthopedic fixation devices designed for soft tissue attachment in sports medicine procedures. These anchors utilize suture-based fixation to secure tendons, ligaments, or other soft tissues to bone, providing a secure and stable repair without the need for metal components. They are categorized under the product code MBI, indicating their use in musculoskeletal applications. The anchors are engineered to minimize bone removal while maintaining strong fixation.
These anchors are supplied as single-use devices, intended for use in sterile surgical environments. They are available in various sizes and configurations, including needle, self-punching, and tie-able options, with accompanying disposable drill kits for precise pilot hole placement. The device holds an FDA 510(k) clearance under the Orthopedic advisory committee, classified as substantially equivalent to a predicate device. Storage and handling must adhere to sterile medical device protocols to ensure integrity and safety prior to use.
Other devices from Stryker Corp.
Questions
AI-generated answers, 20 Sep 2026
What types of soft tissue repairs are the Stryker All-Suture Anchors specifically designed for in sports medicine procedures?
The Stryker All-Suture Anchors are designed for securing tendons and ligaments—or other soft tissues—to bone during sports medicine procedures. They provide a suture-based fixation alternative to metal components, ensuring stable repairs while minimizing bone removal. This makes them suitable for procedures like rotator cuff repairs, ACL reconstructions, or other soft tissue reattachments where secure anchoring is critical.
Are the Stryker All-Suture Anchors reusable, or are they intended for single-use only?
The Stryker All-Suture Anchors are explicitly labeled as single-use devices. They are engineered for sterile surgical environments and should not be reused to maintain patient safety and device integrity. This classification aligns with standard practices for orthopedic fixation devices to prevent contamination and ensure consistent performance.
What sizes and configurations are available for the Stryker All-Suture Anchors, and how do they differ?
The Stryker All-Suture Anchors come in multiple sizes and configurations, including needle-style, self-punching, and tie-able options. The needle-style anchors require pre-drilled holes, while self-punching anchors create their own pilot holes for convenience. Tie-able anchors allow for additional suture adjustments post-insertion, offering flexibility depending on the surgical technique and tissue type being repaired.
What kind of drill kits are provided with the Stryker All-Suture Anchors, and why are they important?
The Stryker All-Suture Anchors are supplied with disposable drill kits designed for precise pilot hole placement. These kits ensure accurate and controlled drilling, which is critical for proper anchor placement and secure fixation. The disposable nature of the drill kits also helps maintain sterility and reduce cross-contamination risks in the operating room.
How should the Stryker All-Suture Anchors be stored to ensure they remain sterile and functional?
The Stryker All-Suture Anchors must be stored and handled according to sterile medical device protocols. This includes keeping them in their original packaging until use, protecting them from moisture, heat, or physical damage, and adhering to manufacturer guidelines for shelf life. Proper storage ensures the anchors remain sterile and maintain their structural integrity for reliable performance during surgery.