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-staging.innolitics.com/productcode/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 920)

Showing 20 most recent of 920 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260063](/device/K260063.md) | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | Sep 11, 2026 | SESE |
| [K262293](/device/K262293.md) | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | Sep 10, 2026 | SESE |
| [K262341](/device/K262341.md) | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | Sep 8, 2026 | SESE |
| [K262130](/device/K262130.md) | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | Sep 4, 2026 | SESE |
| [K253961](/device/K253961.md) | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | Sep 1, 2026 | SESE |
| [K261563](/device/K261563.md) | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | Aug 7, 2026 | SESE |
| [K262251](/device/K262251.md) | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | Jul 31, 2026 | SESE |
| [K261734](/device/K261734.md) | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | Jul 23, 2026 | SESE |
| [K261458](/device/K261458.md) | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | Jun 25, 2026 | SESE |
| [K261032](/device/K261032.md) | NovoKnee (SteriKnee) | NovoSource | Apr 27, 2026 | SESE |
| [K253793](/device/K253793.md) | Materialise TKA Guide System | Materialise NV | Jan 6, 2026 | SESE |
| [K252974](/device/K252974.md) | EMPOWR Knee | Encore Medical L.P. | Dec 19, 2025 | SESE |
| [K253197](/device/K253197.md) | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | Nov 19, 2025 | SESE |
| [K253314](/device/K253314.md) | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | Oct 29, 2025 | SESE |
| [K253144](/device/K253144.md) | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | Oct 22, 2025 | SESE |
| [K252725](/device/K252725.md) | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | Sep 25, 2025 | SESE |
| [K251554](/device/K251554.md) | Materialise TKA Guide System | Materialise NV | Jul 14, 2025 | SESE |
| [K251776](/device/K251776.md) | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | Jul 8, 2025 | SESE |
| [K251241](/device/K251241.md) | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | Jul 2, 2025 | SESE |
| [K251717](/device/K251717.md) | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | Jun 26, 2025 | SESE |

## Top Applicants

- Zimmer, Inc. — 51 clearances
- Smith & Nephew, Inc. — 49 clearances
- Howmedica Corp. — 47 clearances
- Biomet, Inc. — 40 clearances
- Conformis, Inc. — 40 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/JWH](https://fda-staging.innolitics.com/productcode/JWH)

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