# K070227: Opus Magnum PI Knotless Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Apr 16, 2007 after 82 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: 3 generations back to K921873 (1992). 11 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 39 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 1.
- K061349: Opus Labralock P Knotless Fixation Device, Arthrocare Corp. (2006) Summary page 1.

## Most influential descendants
- 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
- K101448: Opus Speedscrew System (2010), 10 descendants of its own
- K131182: Multifix S Knotless Fixation Device (2013), 9 descendants of its own
- K080335: Tornier Cinch Knotless Fixation Implant System (2008), 7 descendants of its own

## Indications for use
The Opus ® MagnumTM PI 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 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/K070227
Methodology: https://510kreport.com/methodology