Home / 510(k) Clearances / K253793

510(k) K253793

Materialise TKA Guide System by Materialise NV — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2026
Date Received
November 28, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Materialise NV

  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF T (January 7, 2026)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (February 21, 2025)
  • K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (October 18, 2024)
  • K223427 — Mimics Enlight CMF (May 31, 2024)
  • K241143 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (May 22, 2024)
  • K233217 — Mimics Cardiac Planner (February 12, 2024)
  • K233408 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (November 9, 2023)
  • K231112 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (September 12, 2023)

Other clearances for product code JWH

  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)
  • K242410 — NextStep Arthropedix Total Knee System (May 8, 2025)