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Stratasys Medical Regulatory Information

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FDA Cleared Diagnostic Workflows

Stratasys is a global leader in additive technology solutions for a variety of industries including healthcare. We deliver 3D printing solutions for patient-specific or general anatomies for production tools, planning, testing, simulation, and training in the dental and medical fields.

Hospitals as point of care manufacturers can now count on the reliability and accuracy of Stratasys’ solutions when creating anatomical models for diagnostic use.

Several PolyJet printers have been validated* for use with Materialise, Synopsys, Ricoh 3D for Healthcare, and Axial3D as part of the FDA-cleared workflow solutions to create accurate anatomical models for diagnostic use:

       J5 MediJet

       J750 Digital Anatomy Printer

       J850 Digital Anatomy Printer

       J750

       J735

 

* Validation applies to the printer, its compatible materials and software.

Materials included in FDA-validated solution**:

Elastico, Agilus, Agilus30Clr, Agilus30, Vero PureWhite, Vero Gray, Vero Clear, Vero Black, Vero WhitePlus, Vero Yellow, Vero Cyan, Vero Magenta, MED610, MED615RGD, VeroWhite, VeroVividTM Cyan, VeroVividTM Magenta, VeroVividTM Yellow, DraftWhite, VeroUltraClearTMS, ElasticoTM Clear, VeroBlackPlus, VeroGrey, VeroPureWhite, VeroUltraWhiteTMS, SUP706, SUP710, ABS‐M30 WHT, QSR Support, BoneMatrixTM

** Please consult individual certifications for exact material guidance

For the latest details of the Stratasys printers and materials validated for different applications under FDA clearances, please visit Materialise, Synopsys, Ricoh 3D for Healthcare, and Axial3D

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 the 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, Synopsys Simpleware ScanIP Medical, RICOH 3D for Healthcare, and Axial3D Cloud Segmentation Software.

These software programs have FDA clearance for this purpose.

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, J735, Objet 30 Prime, and J5 MediJet have been validated by Materialise as part of the FDA-cleared solution to create accurate anatomical models for diagnostic use. 

 

Synopsys Simpleware software has been cleared for 3D anatomical models used for diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications. Stratasys J750, J750 Digital Anatomy Printer, J850 Digital Anatomy Printer, J5 MediJet have been validated by Synopsys as part of a FDA-cleared solution to create accurate anatomical models for diagnostic use.

RICOH 3D for Healthcare received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling. The offered solution is an integrated HIPAA-enabled end-to-end workflow solution for the development, design, and production of 3D-printed anatomic models, produced using Stratasys 3D printing technology. 

The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Both Stratasys J5 MediJet and J750 printers have been validated by Axial3D as part of their FDA-cleared solution.

 

For additional information, refer to FDA’s 3D Printing Medical Devices at the Point of Care: Discussion Paper.

 

J850 Digital Anatomy Printer

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

Find out more about the integrated PolyJet technology and FDA-cleared software.

Find out more about the integrated PolyJet technology and FDA-cleared software.

Read more on the Ricoh Press Release 

Read More on the Materialise Press Release

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