K163497 is an FDA 510(k) clearance for the EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II - Special Controls, product code KWZ).
Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on March 2, 2017, 79 days after receiving the submission on December 13, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310.
| 510(k) Number | K163497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2016 |
| Decision Date | March 02, 2017 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3310 |