K160025 is an FDA 510(k) clearance for the iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Conformis, Inc. (Bedford, US). The FDA issued a Cleared decision on March 7, 2016, 61 days after receiving the submission on January 6, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K160025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2016 |
| Decision Date | March 07, 2016 |
| Days to Decision | 61 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 |