# K061349: Opus Labralock P Knotless Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jul 14, 2006 after 60 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: 2 generations back to K921873 (1992). 10 ancestors in all.
50 later devices descend from it; 4 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042584: Opus Minimagnum Anchor with Inserter, Opus Medical, Inc. (2004) Summary page 1.
- K992487: Mitek Mini Quickanchor Plus, Mitek Products (1999) Summary page 1.
- K051219: Pushlock, Arthrex, Inc. (2005) Summary page 2.
- K002639: Bioknotless Anchor, Mitek Products (2001). Our reading of the summary gave K002619, FDA’s number for Newgen System (Stryker Instruments). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mitek Bioknotless Anchor”. Summary page 2.

## Most influential descendants
- 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
- K101437: Speedfix Suture System (2010), 12 descendants of its own

## Indications for use
The Opus® LabraLockTM P bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such proceditres 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 aiiachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to arterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligamnvnt and tendon avulsions

Source page: https://510kreport.com/device/K061349
Methodology: https://510kreport.com/methodology