US-based paediatric orthopaedic medical device firm WishBone Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its Smart Correction External Fixation System.

This paediatric external fixation system is developed as hexapod external fixator to stabilise and maintain alignment of complicated fractures, soft tissues, and congenital deformity repairs.

It is intended for the treatment of open and closed fractures, arthrodesis, and pseudoarthrosis of long bones.

Additionally, this system can be used for limb lengthening, deformity, and angular correction, boney or soft tissue defect correction, and malunions.

Smart Correction facilitates enhanced accuracy and flexible strut placement

The WishBone Medical Smart Correction System, which is said to have been used in facilities across Asia and Europe since 2009, consists of hexapod external fixator hardware and a flagship planning software.

It is claimed to have a record of higher accuracy compared with Ilizarov fixators and features a design that allows surgeons to perform enhanced calculations with flexible strut placement.

The company intends to develop the system to single-use, sterile packed procedure kits.

WishBone founder and CEO Nick Deeter said: “Developed by our subsidiary, Response Ortho, the System’s predecessor has already improved the quality of life for thousands of patients.

“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.”

WishBone Professional Education vice-president and SC development team leader 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 favourite 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.”

In August this year, WishBone Medical acquired all assets of the privately held medical device companies Back 2 Basics Direct and Orbbö Surgical, expanding its sterile spine product range.