What 3D-Printed Implant Made Medical Device History Earlier This Year?

Earlier this year, 3D Systems received FDA 510(k) clearance for its 3D-printed, patient-specific cranial implant system. The regulatory milestone marked a historic moment for 3D-printed medical devices as it was the first additively manufactured PEEK implant for cranioplasty procedures.

The VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, 3D Systems’ EXT 220 MED 3D printer, Evonik’s VestaKeep i4 3DF polyetheretherketone (PEEK) resin, and a pre-defined production process.

In addition to producing patient-specific cranial implants, the technology reportedly uses up to 85% less material than implants produced by traditional machining. That can have a significant impact on cost when using expensive raw materials such as implantable PEEK.

Norbert Sparrow, editor-in-chief of Plastics Today, a sister publication to MD+DI, writes that PEEK polymer is especially well suited for medical device applications thanks to its biocompatibility, resistance to body fluids, and stability in a range of temperatures. The material’s inherent radiolucency ensures minimal interference in medical imaging. Its performance and mechanical properties that closely mirror those of human bone make PEEK an ideal material specifically for the cranial implant application, according to 3D Systems.

Gautam Gupta, SVP and general manager of medical devices at 3D Systems, said the company is already looking to the next applications for the technology. This could include 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, Gupta noted.

Click here to read more about 3D Systems' technology and how PEEK is uniquely suited for medical device applications.