Home / 510(k) Clearances / K190286

510(k) K190286

Materialise Glenoid Positioning System by Materialise NV — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2019
Date Received
February 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
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)
  • K253793 — Materialise TKA Guide System (January 6, 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)

Other clearances for product code KWS

  • K252418 — Catalyst F1x Shoulder System (November 6, 2025)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)