3D Systems Brings 3D Printed PEEK Cranial Implant to the U.S. with FDA Clearance

For more than 10 years, 3D Systems (NYSE:DDD) has worked hand-in-hand with surgeons to plan over 150,000 patient-specific cases, and develop more than two million instruments and implants from its FDA-registered, ISO 13485-certified facilities in Littleton, Colorado and Leuven, Belgium. In 2017, its Virtual Surgical Planning (VSP) service expanded to include VSP Cranial for craniofacial and cranial procedures, and this week, the company announced that the FDA has granted 510(k) clearance for its 3D printed, patient-specific VSP PEEK Cranial Implant. This includes a complete workflow including segmentation and 3D modeling software, Evonik’s medical-grade VESTAKEEP ® i4 3DF PEEK material, the 3D Systems EXT 220 MED 3D printer (formerly the Kumovis R1), and a pre-defined production process—everything needed to create high-quality, patient-specific cranial reconstruction solutions.

“As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients. Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey,” said Dr. Gautam Gupta, SVP & general manager, medical devices, 3D Systems. “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 U.S. — 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.”

The company says the VSP PEEK Cranial Implant is the first FDA-cleared, 3D printed PEEK implant for cranioplasty procedures to fix skull defects. According to Acumen Research and Consulting, the market for cranial reconstruction was about $1.2 billion in 2021, and is estimated to reach roughly $2.1 billion by 2030. Cranial implants are used in multiple skull repair applications, such as defects, reconstruction, and trauma. As materials and manufacturing methods continue to improve, new solutions will be possible, and the market will continue to grow, so that number doesn’t seem out of the realm of possibility.

PEEK is a high-performance thermoplastic that’s perfect for implants and other medical device applications due to its resistance to bodily fluids, excellent biocompatibility, stability in many temperatures, and mechanical properties that aren’t terribly dissimilar to human bone. Plus, the material’s radiolucency (partly or completely permeable to radiation) means there’s less interference in medical imaging, which can help ensure implant integrity and better evaluation of the surgical site. This clearance from the FDA will allow 3D Systems to majorly expand its range of PEEK products in the U.S. through the EXT 220 MED platform. Speaking of which, the self-contained, cleanroom environment-based 3D printer, when paired with easier post-processing workflows, helps keep costs down for producing patient-specific medical devices at hospitals, and enables faster turnaround as well.

Using the company’s AM solutions, users can fabricate patient-specific cranial implants with up to 85% less material than what traditional machining could achieve, which also helps in cutting costs for implantable PEEK, which is a fairly pricey raw material. As Dr. Gupta mentioned, the VSP PEEK Cranial Implant solution has been used in almost 40 successful cranioplasties throughout Europe, including in Switzerland at University Hospital Basel, in Israel at Tel-Aviv Sourasky Medical Center, and in Austria at Salzburg University Hospital Salzburg.

“3D-printed PEEK cranial plates are an innovative solution that can improve patient care and expand the possibilities for precise, individualized neurosurgery. The solution is revolutionizing the field,” stated Dr. Johannes Pöppe, senior attending surgeon, department of neurosurgery, University Hospital Salzburg. “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.”

3D Systems has plenty of experience in developing patient-specific PEEK implants, and with this new FDA clearance, it’s in a great place to speed up the development process and push for widespread adoption of its VSP PEEK Cranial Implant solution in the U.S. This milestone shows the company’s commitment to helping its partners more efficiently wade through the tricky regulatory landscape of surgical 3D printing.

Images courtesy of 3D Systems