WishBone Medical Granted FDA Clearance for Smart Correction External Fixator

By Julie A. Vetalice

WishBone Medical Granted FDA Clearance for Smart Correction External Fixator

WishBone Medical received FDA 510(k) clearance to market the Smart Correction® External Fixation System, hexapod external fixator hardware and proprietary planning software.

Used in Asia and Europe in over 2,700 cases worldwide since 2009, Smart Correction is designed to offer higher accuracy vs. Ilizarov fixators and unrestricted strut placement. In the future, WishBone will transition the system to single-use, sterile packed procedure kits.

The hexapod external fixator is used to stabilize and maintain alignment of complicated fractures, soft tissues and/or congenital deformity repairs. It is intended to treat open and closed fractures, arthrodesis and pseudoarthrosis of long bones, as well as limb lengthening, deformity and angular correction, bony or soft tissue defect correction and malunions.

Free strut positioning allows surgeons to mount struts wherever needed on a ring without a mounting parameter, master tab or a reference ring.

“Developed by our subsidiary, Response Ortho, the System’s predecessor has already improved the quality of life for thousands of patients,” says Nick Deeter, WishBone’s Founder and CEO. “Together, our teams refined Smart Correction to better suit a child’s body. External fixation in children is a large and growing area, and WishBone Medical has the most advanced software and hardware available. The advantages of Smart Correction will only compound when offered as a single-use, sterile packed procedure kit.”

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory