Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3565](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3565) → MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer # MBH · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer _Orthopedic · 21 CFR 888.3565 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH ## Overview - **Product Code:** MBH - **Device Name:** Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer - **Regulation:** [21 CFR 888.3565](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3565) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K253189.md) | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | Mar 9, 2026 | SESE | | [K253328](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K253328.md) | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | Feb 26, 2026 | SESE | | [K253637](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K253637.md) | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 18, 2026 | SESE | | [K253239](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K253239.md) | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | Dec 23, 2025 | SESE | | [K253161](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K253161.md) | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | Dec 19, 2025 | SESE | | [K252777](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K252777.md) | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | Oct 31, 2025 | SESE | | [K252044](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K252044.md) | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 24, 2025 | SESE | | [K243656](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K243656.md) | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | Jul 31, 2025 | SESE | | [K250980](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K250980.md) | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | May 22, 2025 | SESE | | [K243768](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K243768.md) | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | Mar 27, 2025 | SESE | | [K241597](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K241597.md) | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | Feb 13, 2025 | SESE | | [K243293](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K243293.md) | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | Dec 20, 2024 | SESE | | [K243615](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K243615.md) | Physica Porous Femoral Components | Lima Corporate S.P.A. | Dec 18, 2024 | SESE | | [K242543](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K242543.md) | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | Nov 22, 2024 | SESE | | [K242412](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K242412.md) | Agility Symmetric™ Total Knee System | Medisurge, LLC | Nov 6, 2024 | SESE | | [K243247](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K243247.md) | Persona the Personalized Knee System | Zimmer, Inc. | Oct 29, 2024 | SESE | | [K240393](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K240393.md) | Exactech® TRULIANT® Knee System | Exactech, Inc. | Oct 3, 2024 | SESE | | [K240938](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K240938.md) | The Optimotion™ Blue Plus Knee System | Optimotion Implants, LLC | Jun 27, 2024 | SESE | | [K240678](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K240678.md) | 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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K240299.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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