# K091844: Arthrex Bio-Composite Suturetak Anchors

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Aug 28, 2009 after 67 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: 5 generations back to K961555 (1996). 6 ancestors in all.
100 later devices descend from it; 4 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew, Arthrex, Inc. (2007) Summary page 1.

## Most influential descendants
- K112237: Microsuture Anchors (2011), 77 descendants of its own
- K110660: Arthrex Biocomposite Suturetak (2011), 64 descendants of its own
- K140855: Arthrex Suturetak Suture Anchors (2014), 63 descendants of its own
- K101679: Arthrex Pushlock Anchors (2010), 41 descendants of its own
- K140476: Arthrex Fibertak Suture Anchor (2014), 29 descendants of its own

## Indications for use
The Arthrex Bio-Composite Tak 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/K091844
Methodology: https://510kreport.com/methodology