WishBone Medical’s Pediatric External Fixation System Earns FDA Nod

WishBone Medical Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance on their Smart Correction External Fixation System, which comprises hexapod external fixator hardware and proprietary planning software. Used in facilities across Asia and Europe since 2009, the System boasts a proven record of higher accuracy [compared to Ilizarov fixators] and a design that enables surgeons to perform efficient, precise calculations with unrestricted strut placement. Looking forward, WishBone will ultimately transition the System to single-use, sterile packed procedure kits.
 
The WishBone Medical Smart Correction System is a hexapod external fixator used to stabilize and maintain alignment of complicated fractures, soft tissues and/or congenital deformity repairs. The System is intended for the treatment of open and closed fractures, arthrodesis, and pseudoarthrosis of long bones, as well as limb lengthening, deformity and angular correction, boney or soft tissue defect correction, and malunions.
 
With Smart Correction, free strut positioning allows surgeons to mount struts wherever needed on a ring; neither a mounting parameter, master tab nor a reference ring is required. Eren, et al in the Journal of International Orthopaedics (SICOT)¹ reported, “The SC [Smart Correction] fixator demonstrates higher deformity correction accuracy than an Ilizarov external fixator.” Smart Correction offers a wide variety of wire and pin fixation choices as well as the lowest profile ring to be offered at 6mm. This thinner ring profile allows for more fixation options within the same defined ring span—allowing surgeons to address multiple issues in close proximity at once.
 
“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.”
 
“Smart Correction brings a rich clinical history of over 2,700 successful cases worldwide,” added Skip Roofner, WishBone’s VP of Professional Education and a team leader for SC development. “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.”
 
Reference
¹ Eren, Ilker & Eralp, Levent & Kocaoğlu, Mehmet. (2013). Comparative clinical study on deformity correction accuracy of different external fixators. International orthopaedics. 37. 10.1007/s00264-013-2116-x.