Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
FDA 510(k) K180612 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
510(k) numberK180612
Submission
- Device name
- Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Mahwah, NJ, US - Received
- March 8, 2018
- Decision date
- June 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3520
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261609 | Freedom Partial Knee SystemHSX · Traditional | Maxx Orthopedics, Inc. | 08/04/2026SE |
| K260796 | Tahoe Unicondylar Knee System with TiNbN OvercoatHSX · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 04/02/2026SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | Signature Orthopaedics Pty, Ltd. | 12/16/2025SE |
| K251834 | Persona Partial KneeHSX · Traditional | Zimmer Biomet | 08/15/2025SE |
| K251618 | MOTO Partial Knee System ExtensionHSX · Traditional | Medacta International S.A. | 07/24/2025SE |
| K251453 | Arthrex iBalance Partial Knee SystemHSX · Traditional | Arthrex, Inc. | 07/01/2025SE |
| K241260 | ACTIFY Unicondylar Knee SystemHSX · Traditional | Globus Medical, Inc. | 12/06/2024SE |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK)HSX · Traditional | Smith & Nephew, Inc. | 10/30/2024SE |
| K242746 | OvertureTi Knee Resurfacing SystemTMHSX · Special | Overture Orthopaedics | 10/07/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | Kyocera Medical Technologies, Inc. | 04/04/2024SE |
More from Kyocera Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233261 | Global Modular Replacement SystemJDI · Traditional | 12/08/2023SE |
| K210893 | Restoration Anatomic ShellLPH · Special | 04/22/2021SE |
| K203099 | Triathlon PKR SystemHSX · Traditional | 10/27/2020SE |
| K191358 | Trident II Acetabular SystemLPH · Special | 10/24/2019SE |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemLPH · Traditional | 03/19/2019SE |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsMBH · Traditional | 11/16/2017SE |
| K171768 | Trident® II Acetabular SystemLPH · Traditional | 10/02/2017SE |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsLPH · Traditional | 10/14/2016SE |
Questions and answers
When was Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts cleared by the FDA?
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (K180612) received a 510(k) decision of Substantially Equivalent on June 7, 2018, 91 days after the submission was received.
What is the product code of K180612?
The FDA product code is HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3520.