The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Total Knee System, Triathlon Pkr System, Restoris Mck Knee System.
| Device ID | K172326 |
| 510k Number | K172326 |
| Device Name: | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Klippel |
| Correspondent | Margaret Klippel Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JWH |
| Subsequent Product Code | HRY |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRR |
| Subsequent Product Code | MBH |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2017-10-30 |
| Summary: | summary |