# K191426: FiberTak Button

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Nov 26, 2019 after 181 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: 10 generations back to K961555 (1996). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181769: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2018) Summary page 4.
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button, Arthrex, Inc. (2012) Summary page 4.

## Indications for use
The FiberTak Button is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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 * Hip: Acetabular labral repair The FiberTak Button is also used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; ACL/PCL repair, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

Source page: https://510kreport.com/device/K191426
Methodology: https://510kreport.com/methodology