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) → NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

# NPJ · Prosthesis, Knee Patellofemorotibial, Partial, 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/NPJ

## Overview

- **Product Code:** NPJ
- **Device Name:** Prosthesis, Knee Patellofemorotibial, Partial, 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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150307](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K150307.md) | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | Mar 10, 2015 | SESE |
| [K133039](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K133039.md) | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | Mako Surgical Corporation | Dec 10, 2013 | SESE |
| [K093513](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K093513.md) | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | Dec 16, 2009 | SESE |
| [K093056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K093056.md) | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | Smith & Nephew, Inc. | Dec 15, 2009 | SESE |
| [K090763](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K090763.md) | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | Mako Surgical Corporation | Jun 17, 2009 | SESE |
| [K070849](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K070849.md) | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | Jun 26, 2007 | SESE |
| [K061648](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K061648.md) | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | DePuy Orthopaedics, Inc. | Sep 11, 2006 | SESE |
| [K061569](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K061569.md) | SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS | Smith & Nephew, Inc. | Jul 6, 2006 | SESE |
| [K053488](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K053488.md) | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | Mar 9, 2006 | SESE |
| [K052917](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K052917.md) | STRYKER COMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | Dec 27, 2005 | SESE |
| [K052265](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K052265.md) | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL | Smith & Nephew, Inc. | Dec 27, 2005 | SESE |
| [K042896](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ/K042896.md) | SMITH & NEPHEW HYBRID KNEE FEMORAL | Smith & Nephew, Inc. | Jan 12, 2005 | SESE |

## Top Applicants

- Smith & Nephew, Inc. — 4 clearances
- Conformis, Inc. — 2 clearances
- DePuy Orthopaedics, Inc. — 2 clearances
- Mako Surgical Corporation — 2 clearances
- Howmedica Osteonics Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NPJ)

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