# K042914: Opus Magnum Knotless Anchor with Inserter Handle

- Pathway: 510(k) (Special)
- Applicant: Opus Medical, Inc.
- Decided: Nov 12, 2004 after 22 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.
55 later devices descend from it; 3 cite it directly.
0 of 57 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)

## Most influential descendants
- 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
- K171020: Arthrex Knotless SutureTak Anchor (2017), 27 descendants of its own
- K061294: KFX Knotless Fixation System (2006), 19 descendants of its own
- K072063: KFX Tissue Fixation System and Accessories (2007), 18 descendants of its own

## Indications for use
The Opus MagnumTM 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/K042914
Methodology: https://510kreport.com/methodology