# K012125: Opus Magnum Anchor & Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Sep 17, 2001 after 73 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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.
105 later devices descend from it; 4 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042914: Opus Magnum Knotless Anchor with Inserter Handle (2004), 55 descendants of its own
- K042584: Opus Minimagnum Anchor with Inserter (2004), 52 descendants of its own
- K061349: Opus Labralock P Knotless Fixation Device (2006), 50 descendants of its own
- K060914: Trident Anchor (2006), 33 descendants of its own
- K063478: Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810) (2006), 32 descendants of its own

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

Source page: https://510kreport.com/device/K012125
Methodology: https://510kreport.com/methodology