January 25, 2021

OrthoSpinGen2 400x275OrthoSpin Ltd. announced it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for its second generation, robotic, digitally-enabled external fixation system for orthopedic treatments. The OrthoSpin G2 system is also approved in Israel, and can be used with the DePuy Synthes MAXFRAME Multi-Axial Correction System, the company said.

External fixation devices are a common treatment choice for bone lengthening, setting complex fractures, and correcting deformities, OrthoSpin said. “Patient compliance challenges and a lack of real-time feedback for physician follow-up present substantial challenges,” the company said. Current treatments require that patients manually adjust fixation devices daily, which can cause adjustment errors and non-compliance, as well as involve complicated patient training.

The company said it completed initial clinical cases in the U.S. and Israel with the OrthoSpin Generation 1 system, which makes pre-programmed adjustments automatically without the need for patient involvement. Integrated software lets physicians chart patient progress, and when required, immediately adjust treatment programs. The second-generation system is more user friendly, covers all strut range sizes, and is lighter by 20%, OrthoSpin said.

“We believe that robotic automation will revolutionize the hexapod bone deformity market, and we are proud to play a part in this transformation,” said Dr. Assaf Dekel, active chairman of OrthoSpin.

The company said future applications, such as the ability to follow and modify treatment plans via smartphones and cloud-based AI algorithms based on computerized historical data, have the potential to play a prominent role in medicine and healthcare.

More details are available at the OrthoSpin website.