MBH · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Orthopedic · 21 CFR 888.3565 · Class 2
Overview
| Product Code | MBH |
|---|---|
| Device Name | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Regulation | 21 CFR 888.3565 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.
Classification Rationale
Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
Recent Cleared Devices (20 of 142)
Showing 20 most recent of 142 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | Mar 9, 2026 | SESE |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | Feb 26, 2026 | SESE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 18, 2026 | SESE |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | Dec 23, 2025 | SESE |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | Dec 19, 2025 | SESE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | Oct 31, 2025 | SESE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 24, 2025 | SESE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | United Orthopedic Corporation | Jul 31, 2025 | SESE |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | May 22, 2025 | SESE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | Mar 27, 2025 | SESE |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | Feb 13, 2025 | SESE |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | Dec 20, 2024 | SESE |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | Dec 18, 2024 | SESE |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | Nov 22, 2024 | SESE |
| K242412 | Agility Symmetric Total Knee System | Medisurge, LLC | Nov 6, 2024 | SESE |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | Oct 29, 2024 | SESE |
| K240393 | Exactech® TRULIANT® Knee System | Exactech, Inc. | Oct 3, 2024 | SESE |
| K240938 | The Optimotion Blue Plus Knee System | Optimotion Implants, LLC | Jun 27, 2024 | SESE |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology | Depuy Ireland UC | Jun 18, 2024 | SESE |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer, Inc. | Apr 26, 2024 | SESE |
Top Applicants
- Zimmer, Inc. — 18 clearances
- Smith & Nephew, Inc. — 11 clearances
- Howmedica Osteonics Corp. — 9 clearances
- Wrightmedicaltechnologyinc — 8 clearances
- Biomet, Inc. — 7 clearances
