3DPrint.com April 16, 2024
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,...