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3D Systems Announces FDA Clearance for Products

By 3D Systems Press Release

ROCK HILL, S.C. – 3D Systems -- inventor of 3D printing and creator of Virtual Surgical Planning for craniomaxillofacial (CMF) applications -- today is announcing that the Food and Drug Administration (FDA) has provided 510(k) clearance for maxillofacial surgical guides 3D printed using its 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’ surgical guides produced using these materials as part of its VSP System offer unprecedented flexibility in design options, and are capable of having lower profile designs to enhance visibility and access in the surgical site, while also possessing improved strength and rigidity. Creating patient-specific surgical guides as part of the VSP System has been shown to save surgeons and patients hours in the operating room.

As a pioneer in the personalized medicine space, 3D Systems’ VSP technology received FDA market clearance as 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.

“Through close collaboration with surgeons and Stryker’s CMF division, we’ve uncovered opportunities to refine VSP guide designs that leverage additional capabilities in our materials portfolio,” said Menno Ellis, executive vice president, healthcare solutions, 3D Systems. “Our expert biomedical engineers are now able to design surgical guides tailored to the surgeon’s needs with enhanced properties that can help improve accuracy and facilitate procedures in ways not previously possible. Our powerful VSP System continues to transform surgery – enabling better patient outcomes.” 

Improved Surgical Guide Designs and Performance

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.

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.

Flexibility in Treatment Options

With the new clearance, 3D Systems is pleased to offer an unmatched portfolio of material and guide design options that provides surgeons with the flexibility to better serve the needs of their patients.

The new materials allow for customizable designs, which are tailored to the cutting and drilling instrumentation to be used in surgery, to assist surgeons with accurately performing cutting and drilling operations.

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. The accepted cleaning and sterilization techniques validated for the new guide materials offer unprecedented flexibility in assuring safe patient-matched instrumentation is delivered to the operating room.

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