Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner— 510(k) K220452

Name: FDA 510(k) clearance K220452
Creator: U.S. Food and Drug Administration
Published: 2022-08-17

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K220452 for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner, Substantially Equivalent on 2022-08-17. Applicant: Materialise NV. Device class: 2.

Clearance details

Applicant: Materialise NV
Product code: Product code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2022-02-17
Decision date: 2022-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHE

view all

K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner2026-06-09
K261510 — Signature ONE System2026-06-04
K260104 — Signature ONE System2026-02-04
K251558 — Precision AI Surgical Planning System (PAI-SPS)2026-01-12
K243509 — Archer PSI System2025-05-12

More clearances from Materialise NV

view all

K260913 — CMF Titanium Splints2026-10-09
K251964 — Mimics Thoracic Planner2026-03-12
K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models2026-01-07
K253793 — Materialise TKA Guide System2026-01-06
K251554 — Materialise TKA Guide System2025-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.