510(k) K213827— TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)

Substantially Equivalent

Smith & Nephew, Inc.

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2021-12-08
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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.