Medicrea (EPA:ALMED) said today it won FDA clearance for its IB3D portfolio of 3D-printed titanium interbody devices featuring its AdapTEK technology.
The company’s AdapTEK technology is intended to allow surgeons to create interbody devices customized to individual specifications through in-house additive manufacturing techniques. Customization features include different ranges of footprints, lordotic angles, heights, lateral windows and endplate surface structure, Medicrea said.
“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,” prez & CEO Denys Sournac said in a press release.
Earlier this month, Medicrea said it was seeking a temporary restraining order against K2M Spine and Kinetic Surgical, as well as former sales representatives Chad Jackson, Thom Thomas, Lauren Brown and William Haigh, according to court documents.