Modular Hip System Cleared by FDA

A system that features a patented locking mechanism utilizing tapers and an expanding collet to connect three components into one customized femoral hip stem has been cleared by the U.S. Food and Drug Administration (FDA). The connection technology allows surgeons to select from a wide range of distal stems, metaphyseal bodies, and neck components to create the optimal implant for each patient.

The system, called UniSyn, is being positioned as a high performance implant for both the primary and revision markets by Hayes Medical, Inc. (El Dorado Hills, CA, USA). The company notes that while the importance of intramedullary fit has been well established, surgeons have become increasingly aware of the need to manage the extramedullary aspects of the hip joint. UniSyn will allow them to fit the inside of the femur and then select the neck component that will best restore length, offset, and anteversion of the patient's hip joint.

Hayes acquired the Consensus knee and hip product lines three years ago. "Over the past few years we have worked hard to upgrade and streamline the existing product lines we acquired. Now, it's great to make this new technology available to orthopedic surgeons,” said Daniel Hayes, Ph.D., CEO of Hayes Medical.


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