K070849 is an FDA 510(k) clearance for the DEPUY GCK FEMORAL AND TIBIAL COMPONENTS. This device is classified as a Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code NPJ).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 26, 2007, 90 days after receiving the submission on March 28, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560. The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement..
| 510(k) Number | K070849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2007 |
| Decision Date | June 26, 2007 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NPJ - Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |
| Definition | The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement. |