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 |
|---|---|---|---|
| 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 |
| K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023-01-20 |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2022-10-17 |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | 2022-10-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09348215158972 | World Knee MC Poly Insert - Size 8 - 16mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160371 | World Knee MC Vit-E Poly Insert - Size 7 - 12mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160364 | World Knee MC Vit-E Poly Insert - Size 7 - 11mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160357 | World Knee MC Vit-E Poly Insert - Size 7 - 10mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160340 | World Knee MC Vit-E Poly Insert - Size 7 - 18mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160333 | World Knee MC Vit-E Poly Insert - Size 7 - 17mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160326 | World Knee MC Vit-E Poly Insert - Size 7 - 16mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160319 | World Knee MC Vit-E Poly Insert - Size 7 - 15mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160302 | World Knee MC Vit-E Poly Insert - Size 7 - 14mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160296 | World Knee MC Vit-E Poly Insert - Size 7 - 13mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160289 | World Knee MC Vit-E Poly Insert - Size 7 - 12mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160272 | World Knee MC Vit-E Poly Insert - Size 7 - 11mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215160265 | World Knee MC Vit-E Poly Insert - Size 7 - 10mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158996 | World Knee MC Poly Insert - Size 8 - 18mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158989 | World Knee MC Poly Insert - Size 8 - 17mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158828 | World Knee MC Poly Insert - Size 8 - 10mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158965 | World Knee MC Poly Insert - Size 8 - 15mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158958 | World Knee MC Poly Insert - Size 8 - 14mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158941 | World Knee MC Poly Insert - Size 8 - 13mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158934 | World Knee MC Poly Insert - Size 8 - 12mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158927 | World Knee MC Poly Insert - Size 8 - 11mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158910 | World Knee MC Poly Insert - Size 8 - 10mm, Right | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158903 | World Knee MC Poly Insert - Size 8 - 18mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158897 | World Knee MC Poly Insert - Size 8 - 17mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158880 | World Knee MC Poly Insert - Size 8 - 16mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158873 | World Knee MC Poly Insert - Size 8 - 15mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158866 | World Knee MC Poly Insert - Size 8 - 14mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158859 | World Knee MC Poly Insert - Size 8 - 13mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158842 | World Knee MC Poly Insert - Size 8 - 12mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |
| 09348215158835 | World Knee MC Poly Insert - Size 8 - 11mm, Left | SIGNATURE ORTHOPAEDICS PTY LTD | 2026-06-09 |