# K202355: Stryker Omega PEEK Knotless Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 13, 2020 after 86 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: 9 generations back to K971358 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181083: Stryker All-PEEK Knotless Anchor System, Stryker (2018) Summary page 4.
- K173845: Arthrex SwiveLock, Arthrex, Inc. (2018) Summary page 4.

## Indications for use
The Stryker Omega 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, PosteriorOblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root 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: Capular Repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K202355
Methodology: https://510kreport.com/methodology