# K102539: Icuff Repair Plate, Right; Cuff Repair Plate. Left; Anchor Bolt, 10MM Through 50MM

- Pathway: 510(k) (Traditional)
- Applicant: Shoulder Options, Inc.
- Decided: Feb 24, 2011 after 174 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: 1 generation back to K994364 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994364: Synthes Button Plate, Synthes (Usa) (2000) Summary page 1.

## Indications for use
The Cuff Repair Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

Source page: https://510kreport.com/device/K102539
Methodology: https://510kreport.com/methodology