# K110660: Arthrex Biocomposite Suturetak

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 31, 2011 after 24 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961555 (1996). 7 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091844: Arthrex Bio-Composite Suturetak Anchors, Arthrex, Inc. (2009) Summary page 1.

## Most influential descendants
- K140855: Arthrex Suturetak Suture Anchors (2014), 63 descendants of its own
- K181769: Arthrex FiberTak Suture Anchor (2018), 24 descendants of its own
- K200341: Arthrex FiberTak Suture Anchor (2020), 17 descendants of its own
- K203268: Arthrex FiberTak Suture Anchor (2020), 16 descendants of its own
- K151092: Arthrex Short Suture Anchors (2016), 12 descendants of its own

## Indications for use
The Arthrex BioComposite SutureTak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs: Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repairs; 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.

Source page: https://510kreport.com/device/K110660
Methodology: https://510kreport.com/methodology