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.
Recent Cleared Devices (11 of 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
- DePuy Orthopaedics, Inc. — 4 clearances
- Encore Medical L.P. — 4 clearances
- Biomet Manufacturing Corp — 1 clearance
- Depuy Orthopedics, Inc. — 1 clearance
- Renovis Surgical Technologies, LLC — 1 clearance
