# K062739: Cinch Bone Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Sapphire Medical, Inc.
- Decided: Feb 13, 2007 after 153 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy/Mitek Products' Rotator Cuff QuickAnchor Plus: named in the summary without a submission number
- (no number) Arthrex, Inc.'s PEEK Corkscrew FT: named in the summary without a submission number
- (no number) Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor: named in the summary without a submission number
- (no number) Linvatec Corporation's UltraFix RC: named in the summary without a submission number

## Indications for use
The CINCH Bone Anchor System is intended for the fixation of soft tissue to bone during rotator cuff repair.

Source page: https://510kreport.com/device/K062739
Methodology: https://510kreport.com/methodology