K161945 is an FDA 510(k) clearance for the EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm). This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on September 23, 2016, 70 days after receiving the submission on July 15, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K161945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2016 |
| Decision Date | September 23, 2016 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |