3D SYSTEMS ANNOUNCES FDA CLEARANCE FOR WORLD’S FIRST 3D-PRINTED PEEK CRANIAL IMPLANTS

3D Systems announced the Food and Drug Administration (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 utilizing additive manufacturing 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.

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, making it an ideal choice for many medical device applications. Furthermore, its inherent radiolucency ensures minimal interference in medical imaging, facilitating a clearer evaluation of the surgical site and implant integrity.

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.