# K142643: Stabilynx PEEK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: D3 Dc, LLC /Stabilynx, Inc.
- Decided: Dec 15, 2014 after 89 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 K990987 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070758: Stryker Peek Zip Suture Anchor, Stryker Endoscopy (2007) Summary page 4.

## Indications for use
The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction

Source page: https://510kreport.com/device/K142643
Methodology: https://510kreport.com/methodology