# K181083: Stryker All-PEEK Knotless Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jul 23, 2018 after 90 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: 8 generations back to K971358 (1997). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151342: Arthrex SwiveLock Anchors, Arthrex, Inc. (2016) Summary page 4.

## Most influential descendants
- K202355: Stryker Omega PEEK Knotless Anchor System (2020), 0 descendants of its own

## Recalls of this device
- Jul 19, 2019 · Class II · Z-1147-2020: Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result i
- Jul 19, 2019 · Class II · Z-1148-2020: Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result i

## Indications for use
The Stryker AlI-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. It is indicated for use in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair Hip: Capsular Repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K181083
Methodology: https://510kreport.com/methodology