Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560) → JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer # JWH · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer _Orthopedic · 21 CFR 888.3560 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH ## Overview - **Product Code:** JWH - **Device Name:** Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - **Regulation:** [21 CFR 888.3560](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3560) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 910) Showing 20 most recent of 910 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253793](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K253793.md) | Materialise TKA Guide System | Materialise NV | Jan 6, 2026 | SESE | | [K252974](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K252974.md) | EMPOWR Knee | Encore Medical L.P. | Dec 19, 2025 | SESE | | [K253197](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K253197.md) | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | Nov 19, 2025 | SESE | | [K253314](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K253314.md) | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | Oct 29, 2025 | SESE | | [K253144](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K253144.md) | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | Oct 22, 2025 | SESE | | [K252725](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K252725.md) | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | Sep 25, 2025 | SESE | | [K251554](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K251554.md) | Materialise TKA Guide System | Materialise NV | Jul 14, 2025 | SESE | | [K251776](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K251776.md) | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | Jul 8, 2025 | SESE | | [K251241](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K251241.md) | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | Jul 2, 2025 | SESE | | [K251717](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K251717.md) | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | Jun 26, 2025 | SESE | | [K242410](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K242410.md) | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | May 8, 2025 | SESE | | [K250889](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K250889.md) | EXULT Knee Replacement System | Corentec Co., Ltd. | Apr 17, 2025 | SESE | | [K250677](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K250677.md) | LEGION Total Knee System | Smith & Nephew, Inc. | Apr 2, 2025 | SESE | | [K243991](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K243991.md) | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | Mar 24, 2025 | SESE | | [K250382](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K250382.md) | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | Mar 13, 2025 | SESE | | [K243724](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K243724.md) | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | Mar 6, 2025 | SESE | | [K244039](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K244039.md) | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | Feb 28, 2025 | SESE | | [K243574](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K243574.md) | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | Feb 18, 2025 | SESE | | [K243817](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K243817.md) | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 6, 2025 | SESE | | [K241180](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K241180.md) | Consensus Knee System with TiNbN | Shalby Advanced Technologies | Jan 14, 2025 | SESE | ## Top Applicants - Zimmer, Inc. — 51 clearances - Smith & Nephew, Inc. — 49 clearances - Howmedica Corp. — 47 clearances - Conformis, Inc. — 40 clearances - Biomet, Inc. — 40 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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