K122015 is an FDA 510(k) clearance for the DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 22, 2013, 227 days after receiving the submission on July 10, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K122015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2012 |
| Decision Date | February 22, 2013 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |