Exactech has obtained 510(k) clearance for its TriVerse primary knee replacement system from the US Food and Drug Administration (FDA).

The new primary knee system has been designed to provide cruciate retaining, anterior stabilised and posterior stabilised constructs.

It is intended to offer similar surgical performance in both surgery centres and hospitals.

The TriVerse primary knee replacement system adds to Exactech’s knee solutions portfolio, which includes primary and revision implants and instruments as well as the company’s balanced knee system and completely integrated Guided Personalized Surgery (GPS) platform.

The company stated that the insert bearings for the TriVerse knee system will be available in highly crosslinked vitamin E-stabilised polyethylene only.

Exactech chief marketing officer and large joints senior vice-president Adam Hayden said: “The TriVerse primary knee system is positioned to be a powerful addition to Exactech’s portfolio that leverages proven design principles and data from hundreds of thousands of total knee replacement patients.

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By GlobalData

“TriVerse will offer orthopaedic surgeons an impactful solution that is developed using proven implant design features, intraoperative flexibility and a straightforward approach.”

The company plans a limited-scale commercialisation of the TriVerse primary knee replacement system from the second quarter of next year.

The new knee replacement system will be available alongside a compact set of adjustable mechanical instrumentation.

It is also planned to be compatible with Exactech’s ExactechGPS system in future.

Exactech is engaged in developing and producing implants, instrumentation and smart technologies for joint replacement surgery.

In July, the company introduced the Equinoxe Shoulder Planning App v2.1 in the US.