MCRA Assists 3D Systems in Securing FDA 510(k) Clearance for VSP PEEK Cranial Implant Device

Wednesday, June 19, 2024

MCRA, the premier independent Clinical Research Organization (CRO) and advisory firm specializing in medical devices, diagnostics, and biologics, proudly announces its significant role in achieving FDA 510(k) clearance for 3D Systems' VSP® PEEK Cranial Implant, a pioneering patient-specific, 3D-printed cranial implant solution.

3D Systems partnered with MCRA for regulatory support during their FDA submission process for the VSP PEEK Cranial Implant.

MCRA's leading biocompatibility team collaborated with 3D Systems to develop and execute a biocompatibility strategy, including detailed chemical characterization studies, that satisfied FDA requirements and confirmed the device's biocompatibility for patient use.

The VSP PEEK Cranial Implant is now the first patient-specific, 3D-printed PEEK cranial implant using an extrusion platform to obtain such clearance.

Biocompatibility team was excited to be part of this critical project for 3D Systems. Extensive experience in biocompatibility and familiarity with FDA expectations allowed us to promptly address the necessary requirements to ensure this device received 510(k) clearance.

"This milestone reflects our dedication to advancing patient care through innovative solutions. Successful collaboration with MCRA was crucial in navigating the regulatory process, especially with their expert guidance on biocompatibility.

Partnering with MCRA has been a highly professional and productive experience, and their support was essential in achieving this important milestone."

"MCRA's esteemed biocompatibility team provided exceptional work in bringing 3D Systems' device to market. This achievement demonstrates MCRA's expertise and invaluable service to our clients, contributing to the introduction of key innovations in the healthcare industry."