# K050634: Modification to: Arthrex V-Tak

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 21, 2005 after 12 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022234 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022234: Arthrex Wrist Bio-Anchor, Model AR-1322B, Arthrex, Inc. (2002) Summary page 1.

## Indications for use
The Arthrex V-TakTM is intended to provide fixation of suture to bone in surgeries of the foot, ankle, hand, wrist, and elbow. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Foot: Hallux Valgus reconstruction Ankle: Mid-foot reconstruction

Source page: https://510kreport.com/device/K050634
Methodology: https://510kreport.com/methodology