MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II
FDA product code MBH covers "Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3565. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MBH
- Device Class
- Class II
- Regulation Number
- 888.3565
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251840 | zimmer | Zimmer® Persona® Personalized Knee System | May 28, 2026 |
| K253189 | zimmer | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | March 9, 2026 |
| K253328 | medacta international | GMK 3D Metal Tibial Tray Extension | February 26, 2026 |
| K253637 | howmedica osteonics corp., dba stryker orthopaedics | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I | February 18, 2026 |
| K253239 | signature orthopaedics pty | Active-V Total Knee System; World Total Knee System | December 23, 2025 |
| K253161 | ortho development | Balanced Knee System TriMax Porous Femoral Components | December 19, 2025 |
| K252777 | maxx orthopedics | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | October 31, 2025 |
| K252044 | howmedica osteonics corp., dba stryker orthopaedics | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | October 24, 2025 |
| K243656 | united orthopedic corporation | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | July 31, 2025 |
| K250980 | lima corporate | Physica System (Physica CR Porous Femoral components) | May 22, 2025 |
| K243768 | restor3d | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | March 27, 2025 |
| K241597 | maxx orthopedics | Freedom® Total Knee System - Porous Tibial Base Plate | February 13, 2025 |
| K243293 | zimmer biomet | Zimmer® Persona® Personalized Knee System | December 20, 2024 |
| K243615 | lima corporate | Physica Porous Femoral Components | December 18, 2024 |
| K242543 | zimmer | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | November 22, 2024 |
| K242412 | medisurge | Agility Symmetric Total Knee System | November 6, 2024 |
| K243247 | zimmer | Persona the Personalized Knee System | October 29, 2024 |
| K240393 | exactech | Exactech® TRULIANT® Knee System | October 3, 2024 |
| K240938 | optimotion implants | The Optimotion Blue Plus Knee System | June 27, 2024 |
| K240678 | depuy ireland uc | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized | June 18, 2024 |