K122239 is an FDA 510(k) clearance for the FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING. 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 April 11, 2013, 258 days after receiving the submission on July 27, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K122239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2012 |
| Decision Date | April 11, 2013 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| 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 |