Materialise PKA Guide System
FDA 510(k) K172650 · Materialise NV
510(k) numberK172650
Submission
- Device name
- Materialise PKA Guide System
- Applicant
- Materialise NV
Leuven, BE - Received
- September 5, 2017
- Decision date
- November 20, 2017
- 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 |
|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 06/09/2026SE |
| K251964 | Mimics Thoracic PlannerLLZ · Traditional | 03/12/2026SE |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | 01/07/2026SE |
| K253793 | Materialise TKA Guide SystemJWH · Special | 01/06/2026SE |
| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 10/18/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | 05/31/2024SE |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 05/22/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
Questions and answers
When was Materialise PKA Guide System cleared by the FDA?
Materialise PKA Guide System (K172650) received a 510(k) decision of Substantially Equivalent on November 20, 2017, 76 days after the submission was received.
What is the product code of K172650?
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.