Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner— 510(k) K260802

Name: FDA 510(k) clearance K260802
Creator: U.S. Food and Drug Administration
Published: 2026-06-09

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K260802 for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Substantially Equivalent on 2026-06-09. Applicant: Materialise NV. Device class: 2.

Summary

Materialise's clearance names the Materialise Shoulder System, the Materialise Shoulder Guide and Models, and the SurgiCase Shoulder Planner. The record lists one product code, QHE, shoulder arthroplasty implantation systems.

Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Materialise filed from Leuven, Belgium. The decision came 90 calendar days after FDA received it (March 11 to June 9, 2026).

Clearance details

Applicant: Materialise NV
Product code: Product code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2026-03-11
Decision date: 2026-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

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