# K031083: Opus Magnum Implant System, Model OM-1500

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Jun 12, 2003 after 69 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Opus Magnum Implant is intended for fixation of tendon to bone using a “siky” I1 PolydekB non-absorbable braided polyester or Fiberwire@ braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement. Indications: (1) Shoulder 1) Rotator Cuff Repair

Source page: https://510kreport.com/device/K031083
Methodology: https://510kreport.com/methodology