FDA 510(k)

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

K-Number: K212569 · 2022-01-12

Decision Date2022-01-12

Product CodeQHE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2022-01-12 under approval number K212569. 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 2022-01-12. It is manufactured by Materialise NV. The 510(k) number is K212569.

When was Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner approved by the FDA?

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-01-12, under approval number K212569.

What company makes Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is manufactured by Materialise NV.

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.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202454Smart SPACE Shoulder SystemTechmah Medical, LLC K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerMaterialise NV K212560Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202151Smart SPACE Shoulder SystemTechmah Medical, LLC

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.