FDA Clears 'World’s First' 3D-Printed Cranial Implants

It can produce patient-specific cranial implants with up to 85% less material.

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3D Systems

3D Systems announced the FDA has provided 510(k) clearance for its 3D-printed, patient-specific cranial implant solution — VSP PEEK Cranial Implant.

VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), and a pre-defined production process. By using additive manufacturing solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining.

Furthermore, the cleanroom-based architecture of the printer combined with simplified post-processing workflows makes it an ideal technology for producing patient-specific medical devices at the hospital site with faster turnaround while keeping the overall cost under control. To date, this solution has been used to enable nearly 40 successful cranioplasties in Switzerland at University Hospital Basel, in Austria at Salzburg University Hospital, and in Israel at Tel-Aviv Sourasky Medical Center.

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3D Systems has worked with surgeons for more than a decade to plan over 150,000 patient-specific cases and manufacture more than two million implants and instruments for 100+ CE-marked and FDA-cleared devices from its world-class, FDA-registered, ISO 13485-certified facilities in Littleton, Colorado and Leuven, Belgium.

This FDA clearance enables 3D Systems to significantly expand its PEEK product portfolio through the EXT 220 MED platform. With this milestone, the company is not just introducing a pioneering product; it is setting the stage for a comprehensive range of advanced PEEK-based solutions designed to meet the diverse needs of the medical field. 3D Systems' extensive experience in developing patient-specific PEEK implants, combined with its robust database, places the company in an unparalleled position to accelerate the development process. This expertise is a valuable asset for all existing customers and partners, offering them an expedited pathway to bring their products to market. By leveraging 3D Systems' proven track record and the capabilities of the EXT 220 MED platform, the company is committed to supporting its partners in navigating the regulatory landscape more efficiently, ensuring faster access to innovative medical solutions that enhance patient care and outcomes.

It is anticipated that the use of 3D-printed cranial implants will accelerate based on the availability of advanced technologies. According to a report by Acumen Research and Consulting in February 2023, the cranial implants market size in 2021 was roughly $1.2 billion and is anticipated to approach $2.1 billion by 2030. Cranial implants can address a breadth of applications including trauma, defects, and reconstruction. The continued innovation in materials and manufacturing methodologies such as 3D printing are expected to enable new solutions to catalyze growth in this market.

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