FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

ConforMIS Hip Replacement System Scores 510(k) Clearance

June 30, 2017
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The FDA has granted 510(k) clearance to ConforMIS’ iTotal Hip Replacement System.

The devices use single-use 3D-printed instruments in combination with the company’s patient-specific technology.

The system uses the personalization technology to design customized knee implants, cutting out risks associated with hip replacements such as dislocation, uneven leg lengths and limited reproducibility. Because the replacement hips offer a better match for the patient’s anatomy, the system can address these shortcomings and improve patient outcomes, said Scott Ball, M.D., of the University of California, San Diego’s Department of Orthopedic Surgery, a member of the device’s design team. — Zack Budryk

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