# K232973: Arthrex Knee FiberTak® Button Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 15, 2023 after 55 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: 14 generations back to K961555 (1996). 110 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231330: FiberTak® Suture Anchor, Arthrex, Inc. (2023) Summary page 5.
- K180768: Arthrex SwiveLock Anchors, Arthrex, Inc. (2018) Summary page 5.

## Most influential descendants
- 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
- K250424: Arthrex TightRope Soft Button, RT (2025), 0 descendants of its own

## Indications for use
The Arthrex Knee FiberTak® Button Suture Anchor 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: • Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction • Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers • Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair • Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair • Hip: Acetabular Labral Repair and gluteal tendon repair

Source page: https://510kreport.com/device/K232973
Methodology: https://510kreport.com/methodology