US-based medical device company Exactech has received the US Food and Drug Administration 510(k) approval to market its TriVerse primary knee system.
The TriVerse primary knee system is designed to provide cruciate retaining, anterior stabilised and posterior stabilised constructs.
In addition, the system offers similar surgical performance in both hospitals and surgery centres.
Exactech said that the insert bearings for the primary knee system will be exclusively available in highly cross-linked vitamin E-stabilised polyethylene.
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.
“TriVerse will offer orthopaedic surgeons an impactful solution that is developed using proven implant design features, intraoperative flexibility and a straightforward approach.”
TriVerse system comes with a compact set of adjustable mechanical instrumentation and will be compatible with the company’s ExactechGPS system in the future.
The new system adds to the company’s portfolio of knee solutions, which includes a balanced knee system, primary and revision implants, and instruments and an integrated GPS platform.
The company intends to commercialise TriVerse primary knee system on a limited scale, starting from Q2 2023.
Exactech is engaged in the development and production of implants, instrumentation, and smart technologies for joint replacement surgery.
Earlier this year, the medical device company completed the first surgical procedure using the Spartan Stem and Logical Cup System for total hip arthroplasty.
The Spartan Hip Stem represents the most recent developments in surgical technique with features like three-offset options and a tapered, polished distal segment.
The Logical Cup is an advanced, modular acetabular solution designed to fulfil the needs of patients for a smooth surgical workflow in hospitals and outpatient surgery centres.
