# K111716: Knotless Suture Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Core Essence Orthopaedics
- Decided: Nov 10, 2011 after 143 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: 6 generations back to K961555 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090128: Tac-Tite (TM), Core Essence Orthopaedics, Inc. (2009) Summary page 2.
- K100457: Opus Speedscrew System, Arthrocare Corp. (2010) Summary page 2.

## Indications for use
The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acrornio-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 Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Source page: https://510kreport.com/device/K111716
Methodology: https://510kreport.com/methodology