# K042584: Opus Minimagnum Anchor with Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Dec 14, 2004 after 83 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- 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.
52 later devices descend from it; 3 cite it directly.
0 of 54 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) Summary page 2.
- (no number) Mitek BioKnotless Anchor: named in the summary without a submission number

## Most influential descendants
- K061349: Opus Labralock P Knotless Fixation Device (2006), 50 descendants of its own
- K070227: Opus Magnum PI Knotless Fixation Device (2007), 27 descendants of its own
- K090615: Opus Speedlock Knotless Fixation Device (2009), 18 descendants of its own
- K081893: Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 (2008), 16 descendants of its own
- K100457: Opus Speedscrew System (2010), 15 descendants of its own

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0627-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0628-2012: Product is being removed from the field due to an over-label issue.
- May 11, 2011 · Not classified · Z-0049-2012: ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant.

## Indications for use
The Opus MiniMagnum bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Source page: https://510kreport.com/device/K042584
Methodology: https://510kreport.com/methodology