# K130458: Knotless Fibertak Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 3, 2013 after 70 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: 5 generations back to K990088 (1999). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120155: Arthrex Knotless Suturetak Anchor, Arthrex, Inc. (2012) Summary page 1.
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004)
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 1.

## Most influential descendants
- K252596: Tigon Medical Knotless and Dual Javelin All-Suture Anchors (2025), 1 descendant of its own
- K260921: Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (2026), 0 descendants of its own

## Indications for use
The Arthrex Knotless Fiber Tak Suture Anchor is intended for sutur or tissue fixation in the foot, ankle, knee, hand, wrist. elbow, shoulder, and hip. Specific indications are listed below: Elbow: Biceps Tendon Reatachmrent, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromi-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 Hip: Acetabular Labral repair

Source page: https://510kreport.com/device/K130458
Methodology: https://510kreport.com/methodology