ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)— 510(k) K172210

Name: FDA 510(k) clearance K172210
Creator: U.S. Food and Drug Administration
Published: 2017-10-02

Substantially Equivalent

Stryker Trauma AG

FDA 510(k) clearance K172210 for ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), Substantially Equivalent on 2017-10-02. Applicant: Stryker Trauma AG. Device class: 2.

Clearance details

Applicant: Stryker Trauma AG
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2017-07-24
Decision date: 2017-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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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.