FDA OKs OrthoSpin’s 2nd Gen Robotic, Digital External Fixation System

The U.S. Food and Drug Administration has granted clearance to OrthoSpin’s second generation, robotic, digitally enabled external fixation system for orthopedic treatments, the Generation 2 OrthoSpin system.
 
External fixation devices are commonly used for bone lengthening, setting complex fractures, and correcting deformities. Challenges in patient compliance and a lack of real-time feedback for clinician follow-up are especially challenging. Effective treatment currently requires patients to manually adjust fixation devices every day, necessitating complicated training for patients. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.
 
The firm completed initial U.S. and Israeli clinical cases with the FDA-cleared OrthoSpin Generation 1 system, which makes pre-programmed adjustments automatically without patient involvement. Integrated software lets physicians chart progress and immediately tweak treatment programs when needed. According to OrthoSpin, the second-generation is more user-friendly, covers all strut range sizes, and is 20 percent lighter.
 
“We are very excited to launch the Generation 2 OrthoSpin system,” Dr. Assaf Dekel, Active Chairman of OrthoSpin said in a press release. “We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation.”
 
Future applications, such as the ability to follow and modify treatment plans via smart phones and cloud-based AI algorithms treatment plans based on computerized historical data, could play an increasingly prominent role in medicine and healthcare.
 
The OrthoSpin G2 system is approved in Israel and-cleared for use in USA and can be used with the DePuy Synthes MAXFRAME Multi-Axial Correction System.