OIY · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Orthopedic · 21 CFR 888.3560 · Class 2
Overview
| Product Code | OIY |
|---|---|
| Device Name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| 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 (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242665 | DePuy ATTUNE Total Knee System | Depuy Orthopedics, Inc. | Nov 1, 2024 | SESE |
| K201347 | DePuy ATTUNE Total Knee System | DePuy Orthopaedics, Inc. | Jun 18, 2020 | SESE |
| K120038 | A200 KNEE SYSTEM | Renovis Surgical Technologies, LLC | Feb 14, 2013 | SESE |
| K121727 | MOVATION KNEE SYSTEM | Encore Medical L.P. | Aug 15, 2012 | SESE |
| K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA | Encore Medical L.P. | Mar 14, 2012 | SESE |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | DePuy Orthopaedics, Inc. | Aug 30, 2011 | SESE |
| K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | DePuy Orthopaedics, Inc. | Mar 15, 2011 | SESE |
| K103223 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS | Encore Medical L.P. | Dec 21, 2010 | SESE |
| K101433 | DEPUY ATTUNE KNEE SYSTEM | DePuy Orthopaedics, Inc. | Dec 10, 2010 | SESE |
| K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 | Encore Medical L.P. | Sep 28, 2010 | SESE |
| K100048 | E1 ANTIOXIDANT INFUSED TECHNOLOGY | Biomet Manufacturing Corp | Mar 9, 2010 | SESE |
Top Applicants
- Encore Medical L.P. — 4 clearances
- DePuy Orthopaedics, Inc. — 4 clearances
- Renovis Surgical Technologies, LLC — 1 clearance
- Depuy Orthopedics, Inc. — 1 clearance
- Biomet Manufacturing Corp — 1 clearance
