Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert— 510(k) K253637
Substantially EquivalentHowmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA 510(k) clearance K253637 for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert, Substantially Equivalent on 2026-02-18. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics.
Clearance details
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Product code
- Code MBH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . 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.