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 |
|---|---|---|---|
| E31442422466 | Signature | Materialise NV | 2026-09-24 |
| E31442422653 | Signature | Materialise NV | 2026-09-24 |
| E31442422652 | Signature | Materialise NV | 2026-09-24 |
| E31442422651 | Signature | Materialise NV | 2026-09-24 |
| E31442422650 | Signature | Materialise NV | 2026-09-24 |
| E31442422478 | Signature | Materialise NV | 2026-09-24 |
| E31442422477 | Signature | Materialise NV | 2026-09-24 |
| E31442422476 | Signature | Materialise NV | 2026-09-24 |
| E31442422475 | Signature | Materialise NV | 2026-09-24 |
| E31442422473 | Signature | Materialise NV | 2026-09-24 |
| E31442422472 | Signature | Materialise NV | 2026-09-24 |
| E31442422471 | Signature | Materialise NV | 2026-09-24 |
| E31442422470 | Signature | Materialise NV | 2026-09-24 |
| E31442422468 | Signature | Materialise NV | 2026-09-24 |
| E31442422467 | Signature | Materialise NV | 2026-09-24 |
| E31442411410 | Signature | Materialise NV | 2026-09-24 |
| E31442422465 | Signature | Materialise NV | 2026-09-24 |
| E31442422463 | Signature | Materialise NV | 2026-09-24 |
| E31442422462 | Signature | Materialise NV | 2026-09-24 |
| E31442422461 | Signature | Materialise NV | 2026-09-24 |
| E31442422460 | Signature | Materialise NV | 2026-09-24 |
| E31442422458 | Signature | Materialise NV | 2026-09-24 |
| E31442422457 | Signature | Materialise NV | 2026-09-24 |
| E31442422456 | Signature | Materialise NV | 2026-09-24 |
| E31442422455 | Signature | Materialise NV | 2026-09-24 |
| E31442422453 | Signature | Materialise NV | 2026-09-24 |
| E31442422452 | Signature | Materialise NV | 2026-09-24 |
| E31442422451 | Signature | Materialise NV | 2026-09-24 |
| E31442422450 | Signature | Materialise NV | 2026-09-24 |
| E31442422415 | Signature | Materialise NV | 2026-09-24 |