Materialise TKA Guide System
FDA 510(k) K253793 · Materialise NV
510(k) numberK253793
Submission
- Device name
- Materialise TKA Guide System
- Applicant
- Materialise NV
Leuven, BE - Received
- November 28, 2025
- Decision date
- January 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| 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 |
| 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 |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 11/09/2023SE |
Questions and answers
When was Materialise TKA Guide System cleared by the FDA?
Materialise TKA Guide System (K253793) received a 510(k) decision of Substantially Equivalent on January 6, 2026, 39 days after the submission was received.
What is the product code of K253793?
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.