OrthoSpin Gains FDA Clearance for G2 System

By Julie A. Vetalice

OrthoSpin Gains FDA Clearance for G2 System

OrthoSpin was granted FDA 510(k) clearance to market a next-generation robotic digitally-enabled external fixation system.

The OrthoSpin G2 system is approved in Israel as well, and can be used with the DePuy Synthes MAXFRAME™ Multi-Axial Correction System. Parent company Johson & Johnson led an investment round of $3 million for OrthoSpin's smart robotic external fixation system in 2018.

The company has 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 allows physicians to chart patient progress and immediately adjust treatment programs. The second-generation system is more user friendly, covers all strut range sizes and is 20% lighter than the original.

Future applications and features may include the ability to follow and modify treatment plans via smart phones, and cloud-based AI algorithms treatment plans based on computerized historical data.

"We are very excited to launch the Generation 2 OrthoSpin system," said Dr. Assaf Dekel, Active Chairman of OrthoSpin. "We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation."

Product Labels: External Fixation

Tags: 510(k) Clearance, Regulatory