# K133469: Acumed Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Mar 10, 2014 after 118 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: 4 generations back to K961555 (1996). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 3.

## Most influential descendants
- K212990: Acumed Ankle Syndesmosis Repair System (2022), 0 descendants of its own
- K140925: Acumed Suture Anchor System (2014), 0 descendants of its own

## Indications for use
The Acurned Soft Tissue Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Shoulder: Rotator Cuff Repair, Bankhart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromlo-Clavicular Separation Repair, Deltoid Repair, Capsular shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendlon Repair, Posterior Oblique Ligament Repair and Illioitibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Lnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Source page: https://510kreport.com/device/K133469
Methodology: https://510kreport.com/methodology