Medicrea files FDA 510(k) submission for 3D-printed titanium spinal devices

203
Medicrea’s UNiD lab

Medicrea has filed a 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 personalised surgical planning and analytical services.

Medicrea uses digital surgical modelling, combined with the precise inventory control afforded by in-house 3D-printing technology, to personalise the implant selection and alignment requirements for each patient prior to surgery. According to a press release, this is intended “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”.