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news.US-based orthopedic implants company Amedica has reported that the FDA has granted 510(k) marketing clearance to its Valeo Pedicle Screw system, which is designed to allow surgeons greater flexibility in the positioning of spinal implants.
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The Valeo Pedicle Screw system is a low-profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5 vertebral bodies of the spine as an adjunct to fusion.
According to the company, the implant and related instruments are designed to facilitate greater modularity and to better suit patient anatomy and achieve a consistent supplemental fixation outcome for many indications, including degenerative disc disease, spinal stenosis and failed prior spine fusion surgery.
Ashok Khandkar, CEO of Amedica, said: “Our pedicle screw system and recently cleared cervical plate will complement our line of innovative, silicon nitride ceramic spinal spacers, providing surgeons and patients with an important new option for spinal fixation.”