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news.Orthofix International has received 510(k) approval from the FDA for its new Pillar SA spine interbody device. The company also received a notification of approval to begin selling its CentroNail family of nailing systems in Japan.
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Pillar SA is said to be the latest addition to Orthofix’s line of Pillar Peek spacer systems. The new spinal device is designed to be used in most cases as a stand-alone implant between the spinal vertebrae or as a partial vertebral body replacement, without the need for supplemental internal fixation, during lumbar spinal fusion procedures. The company expects Pillar SA to be available in the US in 2009.
Orthofix’s family of CentroNail nailing systems is said to be designed to stabilize bone fractures in the leg. The internal fixation devices feature titanium construction with multiple locking options, reliable mechanical distal targeting and specialized instrumentation.
Alan Milinazzo, CEO of Orthofix, said: “These two approvals are very important to our respective spine and orthopedic businesses, both in the US and Japan. The continuous introduction of innovative new products to the market, and expansion of the global distribution of our broad product portfolios are key aspects of our growth strategy.”