Pediatric Orthopedic Device Innovation ‘Lags’: Research

University of Missouri—Kansas City researchers say innovation for pediatric orthopedic devices lags substantially behind that for adult orthopedic devices. “These findings are consistent with clinical experience and the common practice of modifying adult implants for off-label use in pediatric patients,” the researchers write in the Journal of Bone and Joint Surgery.

The researchers assessed FDA medical device approval statements for pediatric indications within the approved labeling. They found that of 1,925 devices cleared via the 510(k) pathway, only nine (0.5%) were designed exclusively for pediatrics and 160 (8.3%) included pediatric indications. Five of the nine pediatrics-only devices were for spine and four were for trauma indications, they said.

“Despite longstanding efforts to stimulate innovation for this vulnerable population, our results suggest little progress,” the study report concludes.