Medicrea Gains FDA Clearance for 3D-Printed Ti Interbody

By Julie A. Vetalice

Medicrea enters the 3D-printed interbody device segment, announcing FDA 510(k) clearance to market IB3D™ 3D-printed titanium interbody devices. Further, Medicrea introduced AdapTEK™ additive manufacturing (AM) technology that supports the build of personalized interbody devices.

The submission was filed in January 2017, and clearance comes within the planned year-end deadline.

AdapTEK allows the surgeon to specify the design of devices which are then produced in-house using Medicrea's AM capabilities, without reliance on external suppliers. Devices may employ the company's proprietary HexaLOCK™ structure, designed to enhance bone/implant integration.

These offerings complement Medicrea's UNiD™ HUB surgery planning and analytic software to create patient-specific implants.

Funds raised in a mid-2017 private placement will partially support commercialization of IB3D devices.

Sources: Medicrea International; ORTHOWORLD Inc.


Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory