# K083240: Opus MAGNUM2 and Opus Magnum X Knotless Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jan 12, 2009 after 70 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 4 generations back to K921873 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070227: Opus Magnum PI Knotless Fixation Device, Arthrocare Corp. (2007) Summary page 1.
- K042584: Opus Minimagnum Anchor with Inserter, Opus Medical, Inc. (2004) Summary page 1.

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0609-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0610-2012: Product is being removed from the field due to an over-label issue.
- Aug 8, 2011 · Not classified · Z-0608-2012: Product is being removed from the field due to an over-label issue.

## Indications for use
The Opus Magnum2 and Opus Magnum X bone anchors with inserters are 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 attachment 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/K083240
Methodology: https://510kreport.com/methodology