# K180594: Knotless SutureTak Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 22, 2018 after 108 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: 8 generations back to K961555 (1996). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171020: Arthrex Knotless SutureTak Anchor, Arthrex, Inc. (2017) Summary page 4.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 4.
- K063478: Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810), Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 4.
- K140855: Arthrex Suturetak Suture Anchors, Arthrex, Inc. (2014) Summary page 4.

## Most influential descendants
- K243760: OSSIOfiber® Suture Anchor 2.5-3.5 mm (2025), 0 descendants of its own

## Indications for use
The Knotless SutureTak Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair 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 Reconstructions, 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, Joint Capsule Closure Hip: Capsular Repair, Acetabular Labral repair

Source page: https://510kreport.com/device/K180594
Methodology: https://510kreport.com/methodology