NPJ · Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | NPJ |
|---|---|
| Device Name | Prosthesis, Knee Patellofemorotibial, Partial, 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | Mar 10, 2015 | SESE |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | Mako Surgical Corporation | Dec 10, 2013 | SESE |
| K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | Dec 16, 2009 | SESE |
| K093056 | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | Smith & Nephew, Inc. | Dec 15, 2009 | SESE |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | Mako Surgical Corporation | Jun 17, 2009 | SESE |
| K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | Jun 26, 2007 | SESE |
| K061648 | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | DePuy Orthopaedics, Inc. | Sep 11, 2006 | SESE |
| K061569 | SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS | Smith & Nephew, Inc. | Jul 6, 2006 | SESE |
| K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | Conformis, Inc. | Mar 9, 2006 | SESE |
| K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | Howmedica Osteonics Corp. | Dec 27, 2005 | SESE |
| K052265 | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL | Smith & Nephew, Inc. | Dec 27, 2005 | SESE |
| K042896 | 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
