# K081497: Opus MAGNUM2 Knotless Fixation Device (Model OM-1502), Opus Magnum X Knotless Fixation Device (Model OM-1503)

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Jul 28, 2008 after 60 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: 2 generations back to K012125 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042914: Opus Magnum Knotless Anchor with Inserter Handle, Opus Medical, Inc. (2004) Summary page 1.

## Indications for use
The Opus Magnum X bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Source page: https://510kreport.com/device/K081497
Methodology: https://510kreport.com/methodology