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. Device class: 2.
Summary
Howmedica Osteonics, doing business as Stryker Orthopaedics, filed the Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). The record doesn't describe the insert beyond its name and that code name.
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Howmedica Osteonics filed from Mahwah, New Jersey. The decision came 91 calendar days after FDA received it (November 19, 2025 to February 18, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Product code
- Product code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code MBH
view allMore clearances from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
view all- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- K261624 — Omnifit® 20° Series I Insert +11 more
- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
- K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components
- K250989 — Stryker and Serf hip devices
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.