# K101448: Opus Speedscrew System

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Jun 21, 2010 after 28 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: 6 generations back to K961555 (1996). 19 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K081893: Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500, Arthrocare Corp. (2008) Summary page 1.
- K100457: Opus Speedscrew System, Arthrocare Corp. (2010) Summary page 1.

## Most influential descendants
- K131182: Multifix S Knotless Fixation Device (2013), 9 descendants of its own
- K180951: Responsive Arthroscopy Suture Anchor System (2019), 4 descendants of its own
- K132590: 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device, Insertion Guide with Obturator, TA (2013), 3 descendants of its own
- K140604: Multifix S Knotless Fixation System (2014), 2 descendants of its own
- K222763: Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (2022), 1 descendant of its own

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0614-2012: Product is being removed from the field due to an over-label issue.

## Indications for use
The SpeedScrew 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/K101448
Methodology: https://510kreport.com/methodology