# K041305: Stryker Biozip Suture Anchor System

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jun 14, 2004 after 28 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990987 (2000). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K023192: Stryker Biozip Suture Anchor, Stryker Endoscopy (2003) Summary page 1.

## Most influential descendants
- 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 Styker BioZip Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Rotator cuff repair Bankart repair SLAP lesion repair Acromio-clavicular sepaeration repair Capsular shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair Elbow, Wrist, Hand: Scapholunate ligament reconstruction Ulnar collateral ligament reconstruction radial Collateral ligament reconstruction Biceps tendon reattachment Foot & Ankle Medial instability repair/reconstruction Lateral instability repair/reconstruction Achilles tendon repair/reconstruction Midfoot reconstruction Hallux valgus reconstruction Knee: Extra capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Illiotibial band tenosis Patellar tendon repair Pelvis: Bladder neck suspension procedures The Stryker BioZip Suture Anchor System is intended for single-use only.

Source page: https://510kreport.com/device/K041305
Methodology: https://510kreport.com/methodology