The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Total Knee System.
| Device ID | K173849 |
| 510k Number | K173849 |
| Device Name: | Triathlon Total Knee System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Crowe Klippel |
| Correspondent | Margaret Crowe Klippel Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-19 |
| Decision Date | 2018-02-02 |
| Summary: | summary |