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Pediatric Orthopedic Device Drought Continues, Study Finds

 
• By Elizabeth Orr

A recent review of orthopedic device approvals between 2018 and 2022 found that less than 10% of 510(k) devices – and less than 5% of PMA and de novo products – have been authorized for use in children, highlighting the ongoing lack of pediatric devices.   

Model of spine in foreground of orthopedist treating a young boy.
• Source: Shutterstock

Only a small fraction of orthopedic devices cleared by the US Food and Drug Administration carry pediatric indications, a recent review of agency data found.

The lack of device options for pediatric patients has long hindered treatment of children and adolescents, with many physicians repurposing...

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