OrthoPediatrics Wins FDA Approval for Surgery Plating System; 3Q Revenue Rises

By Kelly Cloonan

OrthoPediatrics received approval from the Food and Drug Administration for a plate-and-screw system for pediatric orthopedic surgeons.

The orthopedic company also separately logged higher revenue in its latest quarter, driven by growth in its scoliosis, trauma and deformity and specialty bracing products.

OrthoPediatrics said its newly approved system supports a range of trauma and deformity surgeries with various plate sizes and aims to boost operating room efficiency.

The company plans to offer the system in a limited release early next year. The company has now received six FDA approvals this year, it said.

The company separately logged a loss of $11.8 million, or 50 cents a share, for the third quarter, compared with a loss of $7.9 million, or 34 cents a share, a year earlier.

Adjusted losses per share were 24 cents.

Revenue rose 12% to $61.3 million. Analysts expected $61.2 million.

The increase was due to growth in its scoliosis, trauma and deformity and specialty bracing products, partially offset by a decline in its machine-vision image guidance system unit and lower stocking and sales to Latin and South America.

The company also cut its outlook for the full year, guiding for revenue of $233.5 million to $234.5 million, down from a prior range of $237 million to $242 million.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

October 28, 2025 17:17 ET (21:17 GMT)