# K020172: Opus Magnum Anchor & Instrument Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Opus Medical, Inc.
- Decided: Jul 22, 2002 after 186 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 K012125 (2001). 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)
- K012125: Opus Magnum Anchor & Inserter, Opus Medical, Inc. (2001)

## Indications for use
The Opus Magnum* Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications: (I) SHOULDER 1.) Rotator Cuff Repair

Source page: https://510kreport.com/device/K020172
Methodology: https://510kreport.com/methodology