Triathlon Total Knee System
FDA 510(k) K173849 · Stryker Orthopaedics
510(k) numberK173849
Submission
- Device name
- Triathlon Total Knee System
- Applicant
- Stryker Orthopaedics
Mahwah, NJ, US - Received
- December 19, 2017
- Decision date
- February 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K211703 | Insignia Hip StemMEH · Traditional | 08/16/2021SE |
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | 08/28/2019SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | 03/19/2018SE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH · Traditional | 10/30/2017SE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateLPH · Traditional | 05/25/2016SE |
| K151264 | Restoration Anatomic ShellLPH · Traditional | 08/10/2015SE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…LPH · Traditional | 02/09/2015SE |
| K143393 | Triathlon Tritanium Cone AugmentsMBH · Traditional | 01/13/2015SE |
| K142462 | Restoration Anatomic ShellLPH · Traditional | 11/14/2014SE |
| K141056 | Triathlon Knee System Posterior Stabilized ComponentsMBH · Traditional | 08/05/2014SE |
Questions and answers
When was Triathlon Total Knee System cleared by the FDA?
Triathlon Total Knee System (K173849) received a 510(k) decision of Substantially Equivalent on February 2, 2018, 45 days after the submission was received.
What is the product code of K173849?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.