ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)— 510(k) K210861

Clearance details

Applicant

Stryker GmbH

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2021-03-23

Decision date

2021-09-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252418 — Catalyst F1x Shoulder System2025-11-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

• K261481 — Pangea Femur Reconstruction System2026-06-29
• K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System2026-02-03
• K253202 — Hoffmann LRF System2025-12-19
• K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System2025-08-20
• K250163 — T2 Alpha Femur Retrograde Nailing System2025-08-13

Death

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →