OrthoPediatrics Gets FDA Clearance for PNP Nail System
By Stephen Nakrosis
OrthoPediatrics, an orthopedic company focused exclusively on pediatric orthopedics, said it received U.S Food and Drug Administration 510(k) clearance for its PNP Retrograde nail system.
A 510(K) submission is made before a device is brought to market to demonstrate it can be marketed as safe and effective, the FDA said.
OrthoPediatrics said the system was designed specifically for pediatric anatomy, and addresses an important unmet market need. The system includes anatomic nails for trauma and straight nails for deformity, the company said.
The platform has supported nearly 15,000 patients worldwide, the company said.
OrthoPediatrics also reported its third quarter financial results, posting a loss per share of 25 cents on revenue of $72.7 million. In the year-ago period, the company reported a loss per share of 50 cents on revenue of $61.3 million.
The company also said it was increasing its 2026 revenue guidance to a range of $270 million to $273 million, from its previous guidance of a range of $265 million to $269 million.
After the bell, the company's shares traded 7% higher, at $25.49. The shares closed the day's regular session with a loss of less than 1%, finishing at $23.82.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
October 27, 2026 17:50 ET (21:50 GMT)
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