Medical device company Valorem Surgical has obtained approval from the US Food and Drug Administration (FDA) for its MaxiMIS Spinal Fixation System.


The system has been developed for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.

Valorem Surgical president and CEO Joseph Jin said: "The FDA clearance and first clinical use of the MaxiMIS minimally invasive, pedicle screw system represents a notch in the win column in a challenging regulatory climate.

"We believe we have developed and commercialized a next generation, minimally invasive solution, and are proud to celebrate this regulatory clearance and first case within a day of each other."

MaxiMIS is said to offer stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities.

According to the company, the system was designed for a minimally invasive approach for less tissue disruption, blood loss, and trauma.

The system is available as a minimally invasive or open screw system in sizes from 4.0 x 25mm to 10.0 x100mm, in monoaxial, polyaxial and cannulated variations.

The company plans the limited market release of the system at the end of first quarter of 2015, and full launch in the second quarter of 2015.

Valorem develops and markets instrumentation and implants to orthopedic and neurosurgical care providers, hospital systems, ambulatory surgery centers, and device distributors.

Image: Spine with pelvis. Photo: courtesy of cooldesign/