JWH · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | JWH |
|---|---|
| Device Name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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 | Materialise TKA Guide System | Materialise NV | Jan 6, 2026 | SESE |
| K252974 | EMPOWR Knee | Encore Medical L.P. | Dec 19, 2025 | SESE |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | Nov 19, 2025 | SESE |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | Oct 29, 2025 | SESE |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | Oct 22, 2025 | SESE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | Sep 25, 2025 | SESE |
| K251554 | Materialise TKA Guide System | Materialise NV | Jul 14, 2025 | SESE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | Jul 8, 2025 | SESE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. | Jul 2, 2025 | SESE |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | Jun 26, 2025 | SESE |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | May 8, 2025 | SESE |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | Apr 17, 2025 | SESE |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | Apr 2, 2025 | SESE |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | Mar 24, 2025 | SESE |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | Mar 13, 2025 | SESE |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | Zimmer, Inc. | Mar 6, 2025 | SESE |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | Feb 28, 2025 | SESE |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | Feb 18, 2025 | SESE |
| K243817 | 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 | 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
