MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II
FDA Device Classification
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 |
|---|
| 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 |
| K240299 | zimmer | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | April 26, 2024 |