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 |
|---|---|---|---|
| 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 |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023-01-20 |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | 2022-10-17 |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2022-10-17 |
| K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327000078 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000511 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000504 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000429 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000382 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000344 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000320 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000290 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000276 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000221 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000207 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000191 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000184 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000177 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000139 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000085 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000061 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000269 | INSTRUMENT | Howmedica Osteonics Corp. | 2016-09-24 |
| 07613327000795 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000788 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000764 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000740 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000733 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000726 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000702 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000696 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000689 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000665 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000641 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |
| 07613327000610 | Triathlon | Howmedica Osteonics Corp. | 2015-05-15 |