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510(k) K231112

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner by Materialise NV — Product Code QHE

K231112 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner". The FDA issued a decision of Substantially Equivalent on September 12, 2023. The device falls under product code QHE (Shoulder Arthroplasty Implantation System), a Class II device regulated under 21 CFR 888.3660. Materialise NV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2023
Date Received
April 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Other clearances by Materialise NV

  • K260802 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (June 9, 2026)
  • 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)

Other clearances for product code QHE

  • K260802 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (June 9, 2026)
  • K261510 — Signature™ ONE System (June 4, 2026)
  • K260104 — Signature™ ONE System (February 4, 2026)
  • K251558 — Precision AI Surgical Planning System (PAI-SPS) (January 12, 2026)
  • K243509 — Archer PSI System (May 12, 2025)
  • K241470 — CORE Shoulder System (February 20, 2025)
  • K243955 — Precision AI Surgical Planning System (PAI-SPS) (January 21, 2025)
  • K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (October 18, 2024)
  • K241097 — Arthrex Virtual Implant Positioning (VIP) System Software (October 2, 2024)
  • K233992 — Precision AI Surgical Planning System (PAI-SPS) (August 5, 2024)

FDA data resources