Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components— 510(k) K172634

Substantially Equivalent

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

FDA 510(k) clearance K172634 for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, Substantially Equivalent on 2017-11-16. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

Clearance details

Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2017-09-01
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.