# K023013: Stryker Xcel Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Feb 26, 2003 after 169 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 K970896 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System, ETHICON, Inc. (1997) Summary page 1.

## Most influential descendants
- K041307: Modification to Stryker Xcel Anchor System (2004), 0 descendants of its own

## Indications for use
The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Bikart 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 is intended for single-use only

Source page: https://510kreport.com/device/K023013
Methodology: https://510kreport.com/methodology