# K041307: Modification to Stryker Xcel 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 K970896 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023013: Stryker Xcel Anchor System, Stryker Endoscopy (2003) Summary page 1.

## Indications for use
The Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Bankart repair SLAP lesion repair Rotator cuff repair Capsular shift repair Biceps tenodesis Acromio-clavicular separation Elbow: Biceps tendon reattachment Foot & Ankle: Achilles tendon repair/reconstruction Lateral stabilization Medial stabilization Knee: Medial collateral ligament repair Lateral collateral ligament repair Joint capsule closure to anterior proximal tibia Posterior oblique ligament or joint capsule to tibia repair Extra capsular reconstruction/ITB tenodesis Patellar ligament and tendon avulsion repairs The Stryker XCEL Anchor System is intended for single-use only.

Source page: https://510kreport.com/device/K041307
Methodology: https://510kreport.com/methodology