ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)— 510(k) K181742

Clearance details

Applicant

Stryker GmbH

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2018-07-02

Decision date

2018-09-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

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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 →