Medicrea files 510(k) submission for FDA clearance of spinal interbody devices
Medicrea Group has filed a 510(k) submission to the US Food and Drug Administration (FDA) for approval of its 3D-printed titanium interbody devices, with UNiD Lab personalised surgical planning and analytical services.
The firm personalises the implant selection and alignment requirements for each patient before a surgery utilising its digital surgical modeling, inventory control and 3D-printing technology.
The personalisation allows the firm to achieve an iterative procedural cycle, improve surgical efficiency, streamline inventory requirements and minimise the number of revision surgeries.
Medicrea Group president and chief executive officer Denys Sournac said: "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.”
UNiD Rod technology was the first service-based approach by the firm to personalised spine.
The spinal implant secured FDA clearance in 2014 and was utilised in more than 1100 spinal procedures by the end of last year.
Medicrea chief commercial officer Rick Kienzle said: “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.”
Medicrea intends to achieve reliable, data-driven personalised patient care using its 3D-printed Titanium technology and compatible UNiD Lab services.
Medicrea designs and manufactures personalised analytical services and implant solutions for the treatment of complex spinal conditions.
The firms distributes more than 30 FDA approved implant technologies.
Image: Staff at the UNiD Lab. Photo: courtesy of Medicrea.