# K101437: Speedfix Suture System

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Oct 29, 2010 after 158 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: 4 generations back to K921873 (1992). 12 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090615: Opus Speedlock Knotless Fixation Device, Arthrocare Corp. (2009) Summary page 1.

## Most influential descendants
- 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
- K140802: Sterispine PS (2014), 4 descendants of its own

## Indications for use
The SpeedFix Suture Implant 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: H-allux 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/K101437
Methodology: https://510kreport.com/methodology