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FDA 510(k)

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

K-Number: K260802 · 2026-06-09

ApplicantMaterialise NV
Decision Date2026-06-09
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K260802. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Materialise NV. The 510(k) number is K260802.

When did Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner received FDA 510(k) clearance on 2026-06-09, under 510(k) number K260802.

Who is the listed applicant for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is QHE.

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryK242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

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Related Devices (Code: QHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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