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FDA clears Orthofix's Pillar SA spinal implant

This article was originally published in Clinica

Executive Summary

Orthofix International has received 510(k) clearance from the US FDA for its Pillar SA spine interbody device. It is designed to be used as a stand-alone implant between the spinal vertebrae or as a partial vertebral body replacement, during lumbar spinal fusion procedures. The device eliminates the need for supplemental fixation, reducing trauma and costs for hospitals, due to reduced surgery times. Orthofix, headquartered in Netherlands Antilles, expects Pillar SA to go on sale in the US in 2009. The interbody device markets in the US and Europe together are estimated to be worth over $1bn in 2007. In addition, the firm's CentroNail nailing systems, which are used to stabilise leg fractures, have been approved in Japan. The CentroNail line includes both tibial and femoral intramedullary nails.

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