# K090615: Opus Speedlock Knotless Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jun 3, 2009 after 86 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- 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.
18 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061349: Opus Labralock P Knotless Fixation Device, Arthrocare Corp. (2006) Summary page 1.

## Most influential descendants
- K101437: Speedfix Suture System (2010), 12 descendants of its own
- K112453: Sterispineps Pedicle Screw (2011), 10 descendants of its own
- K121299: Sterispineps Pedicle Screw, Sterispineps Rod (2012), 6 descendants of its own
- K130632: Sterispine PS Pedicle Screw (2013), 5 descendants of its own
- K150092: STERISPINE PS Pedicle Screw (2015), 4 descendants of its own

## Recalls of this device
- Sep 30, 2010 · Not classified · Z-1952-2011: During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely 

## Indications for use
The Opus SpeedLock Knotless Fixation Device 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/K090615
Methodology: https://510kreport.com/methodology