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.
Cleared Devices (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
- Mako Surgical Corporation — 2 clearances
- DePuy Orthopaedics, Inc. — 2 clearances
- Conformis, Inc. — 2 clearances
- Mako Surgical Corp. — 1 clearance
