FDA Approval for 3D Printed Guides

The Food and Drug Administration has provided 510(k) clearance for maxillofacial surgical guides 3D printed using 3D Systems’ LaserForm Ti and DuraForm ProX PA materials. The new clearance allows for more innovative surgical guide designs that improve performance and is the latest delivery on 3D Systems’ customer-centric approach to address the needs of surgeons performing maxillofacial and reconstructive surgeries.

3D Systems’ VSP technology is a service-based approach to personalized surgery, combining expertise in medical imaging, surgical simulation, and 3D printing. The surgeon initiates the process, bringing their clinical knowledge and desired surgical plan to an online web meeting with a 3D Systems biomedical engineer to simulate and plan the surgical procedure. The outcome is a digital plan that is transferred to the operating room via accurate 3D printed patient-specific models, guides, and templates. 3D Systems has provided VSP solutions or anatomical services in more than 120,000 unique patient cases.

Maxillofacial surgical guides 3D printed using 3D System’s LaserForm Ti and DuraForm ProX PA materials allow for more innovative designs that improve performance.

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3D System’s new material options allow for innovative surgical guide designs that improve performance in surgery. It is now possible to design surgical guides with less overall material bulk while improving strength and durability. Mechanical testing shows that Titanium cutting and marking guides produced in LaserForm Ti are 20x stronger than traditional guides according to Proprietary Mechanical Validation Testing Data on file at 3D Systems. With the improvement in strength, Titanium fibula cutting guides can be 70 percent thinner than traditional guides – facilitating improved access to the surgical site. Similarly, Nylon marking guides produced in DuraForm ProX PA exhibit up to 88 percent higher toughness  – rendering them better able to withstand forces applied during surgery. This enables the creation of thinner guides than previously possible and facilitates a close, snap-like, fit to patient anatomy that cannot be achieved in the traditional material.

Additionally, the guides created using LaserForm Ti and DuraForm ProX PA have been validated with a wider range of cleaning and steam sterilization options. Users now have more flexibility in using manual or automated cleaning methods, and the devices can be steam sterilized using a wrap or pouch under a wider range of accepted sterilization cycles.