# K262809: ArthroTAK Tendon Anchor Kit

- Pathway: 510(k) (Special)
- Applicant: ArthroTAK, LLC
- Decided: Sep 2, 2026 after 26 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 13 generations back to K961555 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252635: ArthroTAK Tendon Anchor Kit, ArthroTAK, LLC (2026) Summary page 5.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 5.

## Indications for use
The ArthroTAK Tendon Anchor Kit is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. -Foot/Ankle: Lateral Stabilization, Medial Stabilization, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. -Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and llliotibial Band Tenodesis. -Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. -Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Source page: https://510kreport.com/device/K262809
Methodology: https://510kreport.com/methodology