K093513 is an FDA 510(k) clearance for the IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM. 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 Conformis, Inc. (Burlington, US). The FDA issued a Cleared decision on December 16, 2009, 33 days after receiving the submission on November 13, 2009.
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 | K093513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2009 |
| Decision Date | December 16, 2009 |
| Days to Decision | 33 days |
| Submission Type | Special |
| 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. |