CD Horizon system pedicle screw gets 510K FDA clearance

289

Medtronic announced in early December 2010 that it had received 510K clearance to treat adolescent idiopathic scoliosis. This marks the first such clearance by the FDA under the Agency’s newly established category for paediatric adolescent idiopathic scoliosis patients treated with posterior pedicle screw instrumentation.

“With this clearance we will now be able to provide training and education to surgeons to treat children diagnosed with adolescent idiopathic scoliosis.” said Doug King, general manager of Medtronic’s Spine business. “Unlike adults, adolescent spines are still in a period of growth. Medtronic is committed to collaborating with some of the world’s best surgeons to develop and advance technologies to address the unique needs of children.”

David L Skaggs, professor and chief of Orthopaedic Surgery at the Children’s Hospital in Los Angeles commented that getting children back to their active lives and potentially reducing the need for additional surgeries are two key advantages of using pedicle screws.

 

About CD Horizon spinal system

The CD Horizon spinal system is a broad platform of fixation technologies, including implants and instruments, designed to provide spinal stabilisation and correction in degenerative, deformity and trauma applications. 

 

More than 500,000 individuals worldwide have been treated using the system, including those patients who suffered from such debilitating conditions as spondylolisthesis and spinal fractures.

 

The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.

(Visited 48 times, 1 visits today)