FDA gives clearance to Warsaw company’s pediatric bone repair system

WARSAW, Ind. (Inside INdiana Business) — WishBone Medical Inc. says it has received U.S. Food and Drug Administration 510(k) clearance on a complex system of rings, wire and screw clamps to help stabilize and mend severely broken and malformed bones in children.

The pediatric orthopedic medical device manufacturer says the Smart Correction External Fixation System can now be used by surgeons in the U.S.

The company says the external fixator and proprietary software is a lightweight frame that gives surgeons a more precise tool. Plus, it offers enhanced patient comfort.

Wishbone says the system is designed for the treatment of open and closed fractures, deformities, non-unions and malunions of bones.

The Kosciusko County company says the medical device has been in use across Asia and Europe since 2009.