The Medicrea® Group recently received Food and Drug Administration (FDA) clearance for its IB3D™ range of 3D-printed Titanium interbody devices and the introduction of AdapTEK™, its surgeon-adaptive technology.
AdapTEK™
Through AdapTEK™ , the pioneer in the convergence of healthcare IT and next-generation, aims to enable a surgeon to create a range of interbody devices to their individual specifications.
These interbody devices are made by the company with complete in-house additive manufacturing capabilities and total control of the internal process without any of the limitations associated with subcontracting external suppliers.
The technology leverages a surgeon’s clinical insight to design implants with a range of different footprints, lordotic angles, heights, lateral windows and endplate surface structure, including the proprietary HexaLOCK™ structure designed to enhance bone-implant interaction during the fusion process.
Denys Sournac, President and Chief Executive Officer, stated, “With the FDA clearance of our 3D-printed Titanium interbodies, we are able to approach a large segment of the spine market, where we were not previously present, with an adaptive range of implants delivered according to the clinical preferences and practices of individual spine surgeons. Our AdapTEK™ technology draws on the Company’s core competency to develop full-service solutions for spine surgery and aligns with the cage planning function of our proprietary UNiD™ HUB surgery planning software. This initial FDA clearance will support future strategic IB3D™ FDA clearances, which we will use to enhance our patient-specific UNiD™ ASI platform with the view of combining advanced cage planning capabilities with additive manufacturing to generate personalized interbody devices based on scientific data and precise MRI measurements at each level to select the right implant from thousands of available options.”
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