ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)— 510(k) K161863

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K161863 for ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA), Substantially Equivalent on 2016-11-23. Applicant: Stryker GmbH.

Clearance details

Applicant: Stryker GmbH
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2016-07-06
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selzach, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.