The following data is part of a premarket notification filed by Howmedica Osteonics Corp. Dba Stryker Orthopaedics with the FDA for Triathlon Total Kneesystem.
| Device ID | K201343 |
| 510k Number | K201343 |
| Device Name: | Triathlon Total KneeSystem |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Shikha Khandelwal |
| Correspondent | Shikha Khandelwal Howmedica Osteonics Corp. Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-20 |
| Decision Date | 2020-07-10 |