WishBone Medical this week announced that it received FDA 510(k) clearance for its pediatric Smart Correction external fixation system.
The device features hexapod external fixator hardware and planning software for a higher accuracy and design that enable surgeons to perform strut replacement procedures. It is designed to stabilize and maintain alignment of complicated fractures, soft tissues and/or congenital deformity repairs.
WishBone’s Smart Correction system is designed to treat open and closed fractures, arthrodesis and pseudoarthrosis of long bones and limb lengthening, deformity and angular correction, boney or soft tissue defect correction, and malunions. The system’s free strut positioning allows surgeons to mount struts on a ring where needed.
“Developed by our subsidiary, Response Ortho, the system’s predecessor has already improved the quality of life for thousands of patients,” founder and CEO Nick Deeter said in a news release. “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.”
The Smart Correction comes in a variety of wire and infixation choices with a low profile ring of 6 mm. The tinnier ring allows for more fixation options in the same defined ring span.
“Smart Correction brings a rich clinical history of over 2,700 successful cases worldwide,” VP of professional education Skip Roofner said. “A number of features enable users to easily and freely assemble a construct specific to the case at hand. The software’s user-friendly interface makes it a favorite amongst surgical teams. It’s evident that designers truly listened to and implemented user feedback across the entire system, down to each pin and wire.”