# K230568: FiberTak Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Apr 1, 2023 after 31 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: 12 generations back to K961555 (1996). 26 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203268: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2020) Summary page 4.

## Most influential descendants
- K231330: FiberTak® Suture Anchor (2023), 5 descendants of its own
- K232973: Arthrex Knee FiberTak® Button Suture Anchor (2023), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 descendants of its own
- K260405: FiberTape Button (2026), 0 descendants of its own
- K250867: Dunamis Screw and Suture Locking System (2025), 0 descendants of its own

## Indications for use
The FiberTak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. * Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction * Shoulder: Rotator CuffRepair, 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 thumbjoint 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, Iliotibial Band Tenodesis, Joint Capsule Closure * Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

Source page: https://510kreport.com/device/K230568
Methodology: https://510kreport.com/methodology