Conformis Gains FDA Clearance for Next-Gen Hip

By Julie A. Vetalice

Conformis announced FDA 510(k) clearance of a next-generation Conformis Hip System. Since limited launch in mid-2018, the device has been used in over 400 surgeries; the new system incorporates design improvements based on surgeon feedback.

The Conformis Hip uses proprietary imaging and design software to create a patient-specific pre-operative surgical plan for use with iJig instruments and patient-matched implants. The instruments work with anatomic landmarks to help place and orient the femoral stem and acetabular cup. A proprietary single-use reamer enables patient-matched reaming.

“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,” said Mark Augusti, Chief Executive Officer. “We believe our system will allow surgeons to improve efficiency in the O.R., and importantly—for the anterior approach—potentially eliminate the use of fluoroscopy.”

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory