# K983557: Stryker Wedge Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Dec 18, 1998 after 66 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960516 (1996). 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)
- K960516: Fastak Suture Anchor, Arthrex, Inc. (1996) Summary page 2.

## Most influential descendants
- K041310: Stryker Wedge Suture Anchor System (2004), 0 descendants of its own

## Recalls of this device
- Feb 7, 2008 · Not classified · Z-1538-2008: Product package may crack and cause loss of sterility.
- Feb 7, 2008 · Not classified · Z-1537-2008: Product package may crack and cause loss of sterility.

## 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, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. 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 procedure as well, and is intended for single-use only. This device is intended for use only for the fixation of non-absorbable synthetic sutures.

Source page: https://510kreport.com/device/K983557
Methodology: https://510kreport.com/methodology