# K193377: TopLock Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics, LLC
- Decided: Nov 25, 2020 after 356 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: 7 generations back to K961555 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X, Core Essence Orthopaedics, LLC (2007) Summary page 4.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 4.

## Indications for use
The TopLock Anchor System is intended to secure soft tissue to bone of: The Shoulder: Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis, Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair The Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair The Ankle and Foot: Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair, Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction

Source page: https://510kreport.com/device/K193377
Methodology: https://510kreport.com/methodology