Stratasys Medical Regulatory Information

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FDA Cleared Solutions

Stratasys J750 and J735 multi-color, multi-texture printers along with the Objet 30 Prime are the first and only Polyjet 3D printers on the market today to be validated by Materialise InPrint as part of the first FDA-cleared solution to create accurate anatomical models for diagnostic use.

Hospitals as Point of Care Manufacturers, can now proceed with peace of mind and can count on the reliability and accuracy of Stratasys’ solutions when creating anatomical models for diagnostic use.

The Stratasys J750/J735: support a wide range of medical applications with the only printer validated with Materialise Mimics that can print in multiple colors and textures in the same part. One printer can create flexible heart models, highly accurate bone and cranial maxillofacial models, transparent surgical oncology, and many more.

Materials included in FDA validated solution: Agilus, VeroMagenta, VeroGray, VeroBlackPlus, VeroCyan, VeroYellow, VeroPureWhite, VeroClear.

Objet 30 Prime: A smaller platform, cost effective entry point to hospital point of care printing that provides the accuracy and resolution of PolyJet high performance printing. Print single materials models from biocompatible transparent materials. Materials included in FDA validated solution: transparent MED610.

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Model of patient’s left atrial appendage (LAA) created with Stratasys and Materialise technology allows surgeons to select the appropriate device and plan the optimal approach to occlude the LAA. Image provided by Materialise.

FDA Regulatory Guidance

Medical models used for diagnostic use may be considered medical devices and subject to regulations. The U.S. FDA considers 3D printed anatomical models that can affect/change diagnosis, patient management, and/or patient treatment as diagnostic tools and, as such, are Class 2 medical devices. The FDA requires that models marketed for diagnostic use be prepared using software that has received FDA clearance, such as Materialise Mimics InPrint. The InPrint software is the first and only cleared FDA software for this purpose. Specifically, the Mimics InPrint software has been cleared for 3D anatomical models used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Stratasys J750 and J735 and the Objet 30 Prime have been validated by Materialise as part of the FDA-cleared solution to create accurate anatomical models for diagnostic use.

For additional information, refer to FDA Current Practices and Regulations document.

3D printed medical models come to life with FDA-cleared solution.

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