K180317 is an FDA 510(k) clearance for the EVOLUTION? Knee Systems ? MR Labeling, EVOLUTION? BIOFOAM? Tibial System, EVOLUTION? Revision Tibial System, EVOLUTION? Revision CCK System. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on May 4, 2018, 88 days after receiving the submission on February 5, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K180317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2018 |
| Decision Date | May 04, 2018 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |