K122395 is an FDA 510(k) clearance for the DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS. This device is classified as a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSN).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 31, 2012, 85 days after receiving the submission on August 7, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110.
| 510(k) Number | K122395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2012 |
| Decision Date | October 31, 2012 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSN - Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |