Medicrea (EPA:ALMED) said today it filed a 510(k) submission to the FDA seeking approval of its 3D-printed titanium interbody devices.
The New York City and Lyon, France-based company’s 3D-printed interbody device services include compatible UNiD Lab personalized surgical planning and analytical services, the company said.
“As the 1st 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,” CEO & prez Denys Sournac said in a press release.
Medicrea touted the 3D-printed device, saying the production process allows the company to personalize the implant selection and alignment requirements for each patient prior to surgery to reduce revisions often seen in spinal surgery.
“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,” CCO Rick Kienzle said in prepared remarks.
Last October, Medicrea said it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients.
The company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed for pediatric deformity surgery.
The devices are designed to better allow surgeons to effectively treat pediatric patients with 40% less implant volume during surgery and a lower construct profile in-situ than other offerings available.
