Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
FDA 510(k) K172326 · Stryker Orthopaedics
510(k) numberK172326
Submission
- Device name
- Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
- Applicant
- Stryker Orthopaedics
Mahwah, NJ, US - Received
- August 1, 2017
- Decision date
- October 30, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 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 |
| K173849 | Triathlon Total Knee SystemMBH · Traditional | 02/02/2018SE |
| 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, Triathlon PKR System, Restoris MCK Knee System cleared by the FDA?
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (K172326) received a 510(k) decision of Substantially Equivalent on October 30, 2017, 90 days after the submission was received.
What is the product code of K172326?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.