Product code MBH
- Device name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3565
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | 2026-09-17 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024-11-06 |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | 2024-10-29 |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | 2024-10-03 |
| K240938 | The Optimotion™ Blue Plus Knee System | Optimotion Implants, LLC | 2024-06-27 |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | 2024-06-18 |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | 2024-04-26 |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | 2024-01-18 |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | Depuy Ireland UC | 2023-12-11 |
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Conformis, Inc. | 2023-09-08 |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Conformis, Inc. | 2023-07-21 |
| K230295 | ATTUNE® Revision Cones | Depuy Ireland UC | 2023-03-10 |
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corporation | 2023-02-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| TKRL0001F7300 | PointCloud Knee Instruments | Unik Orthopedics Inc. | 2026-10-20 |
| TKRL0001F6000 | PointCloud Knee Instruments | Unik Orthopedics Inc. | 2026-10-20 |
| TKRL0001F34K0 | PointCloud Knee Instruments | Unik Orthopedics Inc. | 2026-10-20 |
| TKRL0001F1B80 | PointCloud Knee Instruments | Unik Orthopedics Inc. | 2026-10-20 |
| TKRL0001F1540 | PointCloud Knee Instruments | Unik Orthopedics Inc. | 2026-10-20 |
| 00889024486621 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486782 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486775 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486768 | X-PSI Knee | Orthosoft Inc | 2018-04-18 |
| 00889024486751 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486744 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486737 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486720 | X-PSI Knee | Orthosoft Inc | 2018-04-18 |
| 00889024486614 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486607 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486591 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486584 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486577 | X-PSI™ | Orthosoft Inc | 2018-04-18 |
| 00889024486706 | X-PSI Knee | Orthosoft Inc | 2018-04-17 |
| 00889024486713 | X-PSI Knee | Orthosoft Inc | 2018-04-17 |
| 00889024305786 | PSI Knee | Orthosoft Inc | 2017-09-28 |
| 00889024305779 | PSI Knee | Orthosoft Inc | 2017-09-28 |
| 00889024305762 | Persona® | Orthosoft Inc | 2017-09-28 |
| 00889024305755 | PSI Knee | Orthosoft Inc | 2017-09-28 |
| 00889024305618 | Persona® | Orthosoft Inc | 2017-09-28 |
| 00889024305601 | Persona® | Orthosoft Inc | 2017-09-28 |
| 00889024305595 | Persona® | Orthosoft Inc | 2017-09-28 |
| 00889024305588 | Persona® | Orthosoft Inc | 2017-09-28 |
| 00889024305564 | PSI Knee | Orthosoft Inc | 2016-09-07 |
| 00889024305571 | Persona | Orthosoft Inc | 2016-09-07 |