# K252314: Arthrex SutureTak Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 29, 2025 after 96 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: 9 generations back to K961555 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151092: Arthrex Short Suture Anchors, Arthrex, Inc. (2016) Summary page 5.
- K110660: Arthrex Biocomposite Suturetak, Arthrex, Inc. (2011) Summary page 5.
- K181746: MICRORAPTOR Knotless Suture Anchor, Smith and Nephew, Inc. (2018) Summary page 5.

## Indications for use
The Arthrex BioComposite 2.0 mm SutureTak Suture Anchor is intended for suture (soft tissue) fixation to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip in the following procedures: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis • Hip: Acetabular Labral Repair and Reconstruction The Arthrex PEEK Mini Hip SutureTak is intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, Acetabular Labral Repair and Reconstruction.

Source page: https://510kreport.com/device/K252314
Methodology: https://510kreport.com/methodology