3D Systems achieves 510(k) clearance for PEEK cranial implants

The Food and Drug Administration (FDA) has provided 510(k) clearance for 3D Systems’ 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 utilizing AM solutions, this technology can produce patient-specific cranial implants with up to 85% less material than similar implants produced by traditional machining, which can lead to significant cost savings for an expensive raw material like implantable PEEK. 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.

“3D printed PEEK cranial plates are an innovative solution that can improve patient care and expand the possibilities for precise, individualized neurosurgery,” said Dr. Johannes Pöppe, Senior Attending Surgeon at the Department of Neurosurgery in the University Hospital Salzburg. “The solution is revolutionizing the field. The combination of 3D Systems’ printing technology that is uniquely engineered for sterile environments along with the mechanical properties of PEEK are helping surgeons push boundaries. Within our hospital, we have already completed several successful surgeries using these technologies. I believe the potential for customized PEEK cranial plates is significant to integrate 3D printing into routine clinical practice.”

The VSP PEEK Cranial Implant is the first FDA-cleared, additively manufactured PEEK implant intended for cranioplasty procedures to restore defects in the skull. This implant-grade, high-performance polymer has a well-known clinical history in medical device applications due to its exceptional performance with mechanical properties closely mirroring human bone. In addition, PEEK has excellent biocompatibility, resistance to bodily fluids, and stability in a wide range of temperatures. Furthermore, its inherent radiolucency ensures minimal interference in medical imaging – facilitating a clearer evaluation of the surgical site and implant integrity.

“As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients,” said Dr. Gautam Gupta, SVP and General Manager of Medical Devices at 3D Systems. “Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey. Our EXT 220 MED printing system has already enabled the production of nearly 40 cranial implants in support of successful cranioplasties throughout Europe. With this FDA clearance, we are now able to bring VSP PEEK Cranial Implant to the US – setting a new standard of excellence for these procedures. We are now looking to the next applications for this technology, which includes 3D printed spine interbody fusion implants, carbon fiber-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.”

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 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, high-performance PEEK implants, combined with its robust database, places the company in an unparalleled position to accelerate the development process.

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.