MBH
- Product code
- MBH
- Device name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3565
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 24
- Summaries archived here
- 22 (direct download)
- 510(k) clearances (all years, FDA)
- 144 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253728 | 2026-08-21 | Microport Orthopedics, Inc. | EVOLUTION® AM BIOFOAM® Tibial System | |
| K251840 | 2026-05-28 | Zimmer, Inc. | Zimmer® Persona® Personalized Knee System | |
| K253189 | 2026-03-09 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Porous… | |
| K253328 | 2026-02-26 | Medacta International S.A. | GMK 3D Metal Tibial Tray Extension | |
| K253637 | 2026-02-18 | Howmedica Osteonics Corp., Dba Stryker… | Triathlon® Total Knee System - Triathlon® X3® Medial… | |
| K253239 | 2025-12-23 | Signature Orthopaedics Pty, Ltd. | Active-V Total Knee System; World Total Knee System | |
| K253161 | 2025-12-19 | Ortho Development Corp. | Balanced Knee System TriMax Porous Femoral Component… | |
| K252777 | 2025-10-31 | Maxx Orthopedics, Inc. | Freedom Metaphyseal Cone Implants (Metaphyseal Cones… | |
| K252044 | 2025-10-24 | Howmedica Osteonics Corp., Dba Stryker… | Triathlon® Total Knee System - Triathlon® Gold Femor… | |
| K243656 | 2025-07-31 | United Orthopedic Corporation | U2 Total Knee System PF+ Patella; USTAR II System… | |
| K250980 | 2025-05-22 | Lima Corporate S.P.A. | Physica System (Physica CR Porous Femoral components… | |
| K243768 | 2025-03-27 | Restor3D, Inc. | iTotal® Identity Cruciate Retaining 3DP Porous Knee… | |
| K241597 | 2025-02-13 | Maxx Orthopedics, Inc. | Freedom® Total Knee System - Porous Tibial Base Plat… | |
| K243293 | 2024-12-20 | Zimmer Biomet | Zimmer® Persona® Personalized Knee System | |
| K243615 | 2024-12-18 | Lima Corporate S.P.A. | Physica Porous Femoral Components | |
| K242543 | 2024-11-22 | Zimmer, Inc. | Persona the Personalized Knee System (Persona Ti-Nid… | |
| K242412 | 2024-11-06 | Medisurge, LLC | Agility Symmetric Total Knee System | |
| K243247 | 2024-10-29 | Zimmer, Inc. | Persona the Personalized Knee System | |
| K240393 | 2024-10-03 | Exactech, Inc. | Exactech® TRULIANT® Knee System | |
| K240938 | 2024-06-27 | Optimotion Implants, LLC | The Optimotion Blue Plus Knee System | FDA |
| K240678 | 2024-06-18 | Depuy Ireland UC | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized… | |
| K240299 | 2024-04-26 | Zimmer, Inc. | Persona the Personalized Knee System (Persona OsseoT… | |
| K233507 | 2024-01-18 | Microport Orthopedics, Inc. | EVOLUTION® Tibial Cones | |
| K232303 | 2023-12-11 | Depuy Ireland UC | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized… | FDA |
Official FDA classification page: MBH
Classification and pathway per current FDA publications. Data from openFDA (CC0).