3-D Printed Cranial Implant Gets 510(k) Clearance

A 3D-printed, patient-specific cranial implant solution received 510(k) clearance Monday from the FDA.

South Carolina-based 3D Systems claims its VSP PEEK (polyetheretherketone) Cranial Implant is the world’s first FDA-approved, 3D-printed PEEK implant utilizing additive manufacturing solutions designed for cranioplasty procedures to reestablish skull defects.

The company believes the FDA clearance enables widespread adoption of EXT 200 MED, a self-contained, cleanroom environment-based printing system with medical-grade PEEK materials and establishes a foundation for expanded applications to additional orthopedic surgical indications.

3D-printed PEEK implants using the EXT 220 MED were successfully demonstrated in nearly 40 cranioplasties across Europe, 3D Systems says.

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