# K023192: Stryker Biozip Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 20, 2003 after 176 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K990987 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990987: Bio-Absorbable Corkscrew, Model AR-1920B, Arthrex, Inc. (2000) Summary page 1.

## Most influential descendants
- K041305: Stryker Biozip Suture Anchor System (2004), 3 descendants of its own
- K070758: Stryker Peek Zip Suture Anchor (2007), 2 descendants of its own
- K180759: SECULOK™ Suture Anchor (2018), 0 descendants of its own
- K142643: Stabilynx PEEK Suture Anchor (2014), 0 descendants of its own

## Indications for use
The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Elbow, Wrist, Hand: Rotator Cuff Repair Scapholunate Ligament Reconstruction Bankart Repair Ulnar Collateral Ligament Reconstruction SLAP Lesion Repair Radial Collateral Ligament Reconstruction Acromio-Clavicular Separation Repair Biceps Tendon Reattachment. Capsular ShifVCapsulolabral Reconstruction Biceps Tenodesis Foot and Ankle: Deltoid Repair. Medial Instability RepairReconstruction Lateral Instability RepairReconstruction Knee: Achilles Tendon Repair/Reconstruction Extra Capsular Repairs Midfoot Reconstruction Medial Collateral Ligament Hallux Valgus Reconstruction. Lateral Collateral Ligament Posterior Oblique Ligament Pelvis: Bladder Neck Suspension Procedures. Illiotibial Band Tenodesis Patellar Tendon Repair. ' The Stryker BioZip Suture Anchor is intended for single-use only.

Source page: https://510kreport.com/device/K023192
Methodology: https://510kreport.com/methodology