FDA approves J&J spinal device for rare pediatric syndrome

by Val Kennedy at MassDevice

Johnson & Johnson's (NYSE:JNJ) DePuy Synthes Spine unit has won U.S. regulatory approval for a titanium rod device for the treatment of a rare congenital condition known as thoracic insufficiency syndrome.

The FDA awarded 510(k) market clearance for DePuy's vertical expandable prosthetic titanium rib devices for TIS, which can cause severe deformities of the spine, chest or ribs. The devices were previously available to doctors through a humanitarian device exemption from the federal watchdog agency.

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