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Medicrea announces 510(k) submission for FDA clearance of 3D-printed titanium spinal interbody devices

Published 11 January 2017

The Medicrea Group has announced the filing of its 510(k) submission to the US Food and Drug Administration (FDA) for approval of the company’s 3D-printed Titanium interbody devices, with compatible UNiD Lab personalized surgical planning and analytical services.

Denys SOURNAC, President and CEO, stated, “As the first company in spine to develop the highly technical capabilities and differentiated infrastructure required to support a personalized approach to each individual spinal surgical procedure, Medicrea continues to further advance its leading position in the U.S. market, which is estimated at nearly $6 billion, for our UNiD™ patient-specific technologies.

“With in-house additive manufacturing capabilities and FDA clearance anticipated before the end of 2017, Medicrea’s platform of 3D-printed Titanium devices will enable the Company to provide an even more robust and comprehensive solution for patients and surgeons.”

Rick KIENZLE, Chief Commercial Officer, added, “The associated UNiD™ Lab services enable the surgeon to pre-operatively define the exact 3D-printed interbody anatomical specifications matched with a predictive analysis of global spinal alignment parameters, directly linked to clinical results.”

The Company’s deep expertise with digital surgical modeling, combined with the precise inventory control afforded by in-house 3D-printing technology, enables Medicrea to personalize the implant selection and alignment requirements for each patient prior to surgery in order to achieve an iterative procedural cycle, thereby increasing surgical efficiency, streamlining inventory requirements and significantly reducing the high number of costly revision surgeries currently experienced in traditional spinal surgery.

Medicrea first introduced its comprehensive, service-based approach to personalized spine with UNiD™ Rod technology, the first patient-specific spinal implant to be FDA-cleared in late 2014, which recently surpassed 1,100 procedures at the end of 2016.

With the development of 3D-printed Titanium technology and compatible UNiD™ Lab services, Medicrea continues to transform the relationship between healthcare providers and device manufacturers in the spine industry by creating a collaborative interaction that results in reliable, data-driven personalized patient care.



Source: Company Press Release