# K180763: CuffLink Implant System Biocomposite

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jul 19, 2018 after 118 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911837 (1991). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171592: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver, Conmed Corporation (2017) Summary page 4.
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures, Conmed Corporation (2014) Summary page 4.

## Indications for use
INTENDED USE The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. INDICATIONS FOR USE The CuffLink™ Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures. Procedure Joint Rotator cuff repair Shoulder Achilles Repair Ankle

Source page: https://510kreport.com/device/K180763
Methodology: https://510kreport.com/methodology