Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries.
The Billerica, Mass.–based company began hip surgeries in July 2018 during a limited launch of its hip system. The latest version of the system, announced yesterday, incorporates design improvements based on surgeon feedback after more than 400 surgeries were completed with the hip system.
Conformis said its hip system’s design process is similar to the one used for its knee technologies, using imaging and design software to deliver a patient-specific pre-operative surgical plan with a set of disposable surgical iJig instruments and patient-matched implants.
The iJigs are designed to work with anatomic landmarks to ensure proper placement and orientation of the femoral stem and acetabular cup in the hip system. Conformis’ reamer system is also designed to offer a single-use, patient-matched solution that adds efficiency and accuracy to the operation.
“Our new Conformis hip system is compatible with multiple surgical approaches and is designed to provide the surgeon an efficient and accurate experience in the execution of the operative plan,” Conformis CEO Mark Augusti said in a news release. “We believe our system will allow surgeons to improve efficiency in the OR, and importantly — for the anterior approach — potentially eliminate the use of fluoroscopy.”
The company previously won FDA clearance for its primary iTotal hip replacement system, which features Conformis’ iFit technology that applies single-use, custom 3D printed instruments and reusable instruments to deliver a customized hip replacement.