FDA Approves Mechanically Integrated Pedicle Screw System

The thoracolumbar pedicle screw system, brand name OsteoCentric Spine MIS Pedicle Fastener System, manufactured by OsteoCentric Technologies is, of course, “intended for fixation and stabilization of spinal segments in skeletal mature patients as a combined treatment for acute and thoracic, lumbar and chronic sacral instability or deformity” .
Specifically, pedicle screws are intended for “non-cervical pedicle fixation for the following indications:
The thoracolumbosacral pedicle screw system is essentially the same as the Altus Partners, LLC thoracolumbosacral pedicle screw system.
According to OsteoCentric, the OsteoCentric Pedicle Screw Fastener System™ will feature UnifiMI technology. In a press release, Eric Brown, Founder and CEO of OsteoCentric, explained, “The UnifiMI stem attachment system will be the only system on the market that uses mechanical integration technology to eliminate implant instability at the bone-implant interface.”
With FDA 510(k) approval for the pedicle screw system, OsteoCentric has gained additional momentum in the market with FDA 510(k) approval for its sacroiliac joint system and a capital growth fund led by OnPoint Advisors. The Foundation will support mechanical integration in orthopedics and dentistry.


Post time: Dec-20-2022