# K260561: Arthrex FiberTak Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 20, 2026 after 29 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). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221396: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2022) Summary page 5.
- K251809: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2025) Summary page 5.
- K060478: Arthrex Bio-Compression Screw, Arthrex, Inc. (2006) Summary page 5.

## Indications for use
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • 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, lliotibial Band Tenodesis, Joint Capsule Closure • Hip: Capsular Repair, Acetabular Labral Repair and Reconstruction, Gluteal Tendon Repair The 1.8 Knotless FiberTak® Soft Anchor with #2 Suture is also intended to be used for osteochondral fixation and fractures, including surgeries with autograft and allograft tissues, in the Knee and Hip.

Source page: https://510kreport.com/device/K260561
Methodology: https://510kreport.com/methodology