Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
FDA 510(k) K253637 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) numberK253637
Submission
- Device name
- Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Mahwah, NJ, US - Received
- November 19, 2025
- Decision date
- February 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | United Orthopedic Corporation | 07/31/2025SE |
More from United Orthopedic Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | 08/06/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | 07/10/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | 12/15/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | 10/24/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | 07/25/2025SE |
| K250989 | Stryker and Serf hip devicesLPH · Traditional | 07/25/2025SE |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…JWH · Traditional | 02/06/2025SE |
| K243784 | Stryker Orthopaedics Hip Devices Labeling UpdateLPH · Traditional | 02/06/2025SE |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…JWH · Traditional | 12/04/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | 08/02/2024SE |
Questions and answers
When was Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert cleared by the FDA?
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637) received a 510(k) decision of Substantially Equivalent on February 18, 2026, 91 days after the submission was received.
What is the product code of K253637?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.