# K041310: Stryker Wedge Suture Anchor System

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jun 14, 2004 after 28 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: 2 generations back to K960516 (1996). 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)
- K983557: Stryker Wedge Suture Anchor, Stryker Endoscopy (1998) Summary page 1.

## Indications for use
The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, Bankart lesion repair, and SLAP lesion repair in the shoulder, as well as Achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, biceps tendon reattachment in the elbow, and bladder neck suspension in the pelvis. The suture anchor engages in bone so as to provide a stable, bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedures as well, and is intended for single-use only.

Source page: https://510kreport.com/device/K041310
Methodology: https://510kreport.com/methodology