The new system integrates both anatomic nails for trauma cases and straight nails for deformity correction, filling a specialized gap in the pediatric orthopedic market. According to the company, the platform has already been utilized in nearly 15,000 procedures globally. The 510(k) submission confirms that the device meets safety and efficacy standards required for commercial distribution in the United States.
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OrthoPediatrics Wins FDA Nod for Pediatric Nail System
The FDA has granted 510(k) clearance to OrthoPediatrics for its PNP Retrograde nail system, a specialized platform engineered to address specific skeletal needs in children. This regulatory approval arrives as the company reports narrowing quarterly losses and an upward revision of its long-term financial revenue targets.
Financial performance continues to track toward recovery, with the company posting a loss of 25 cents per share on $72.7 million in revenue for the third quarter, compared to a 50-cent loss on $61.3 million during the same period last year. Bolstered by these results, management raised its 2026 revenue guidance to a range of $270 million to $273 million. Investors reacted positively to the news, sending shares up 7% to $25.49 in after-hours trading.
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