# K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 1, 2003 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961555 (1996). 1 ancestor in all.
478 later devices descend from it; 4 cite it directly.
0 of 480 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961555: Acufex Tag Bioabsorbable Anchors, Acufex Microsurgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor (2006), 477 descendants of its own
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), 283 descendants of its own
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew (2007), 227 descendants of its own
- K061154: Kinsa Suture Anchor (2006), 162 descendants of its own
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew (2009), 159 descendants of its own

## Recalls of this device
- Aug 6, 2013 · Class II · Z-2216-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2219-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2215-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2217-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- Aug 6, 2013 · Class II · Z-2218-2013: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

## Indications for use
1. Bankart Lesion Repair 2. Rotator Cuff Repair 3. Capsular Stabilization 4. Anterior Shoulder Instability Repair 5. Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of: - Bunionectomy - Lateral ankle instability - Biceps tendon reattachment

Source page: https://510kreport.com/device/K031685
Methodology: https://510kreport.com/methodology