# K041440: Opus Magnum Anchor with Inserter

- Pathway: 510(k) (Special)
- Applicant: Opus Medical, Inc.
- Decided: Jun 25, 2004 after 24 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
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Opus Magnum® Implant Set: named in the summary without a submission number

## Most influential descendants
- K061294: KFX Knotless Fixation System (2006), 19 descendants of its own
- K072063: KFX Tissue Fixation System and Accessories (2007), 18 descendants of its own
- K081598: Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce Suture (2008), 16 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own

## Indications for use
The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

Source page: https://510kreport.com/device/K041440
Methodology: https://510kreport.com/methodology