# K112814: Cuffink

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Jan 17, 2012 after 112 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 K990088 (1999). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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 2.
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 2.
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture, Teleflexmedical, Inc. (2007) Summary page 2.
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK, Teleflex Medical (2010) Summary page 2.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 2.

## Indications for use
The Cayenne Medical, Inc. CuffLinkTM Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.

Source page: https://510kreport.com/device/K112814
Methodology: https://510kreport.com/methodology