# K140925: Acumed Suture Anchor System

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: May 20, 2014 after 39 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 K961555 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133469: Acumed Suture Anchor System, Acumed, LLC (2014) Summary page 2.

## Indications for use
The Acumed 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. Acromio-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 Tendon Repair. Posterior Oblique Ligament Repair and liliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Rcattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Source page: https://510kreport.com/device/K140925
Methodology: https://510kreport.com/methodology