Corin gets FDA approval of Unity Knee insert for robotic knee replacement

By Sean Whooley | October 6, 2024

Corin Group PLC last week said it has received 401(k) clearance from the U.S. Food and Drug Administration for for its Unity Knee medial constrained, or MC, tibial insert. The Cirencester, U.K.-based company said this option will enable surgeons to independently stabilize the medial compartment during a standard or robotic-assisted total knee arthroplasty, or TKA.

The Unity Knee MC Tibial Insert was designed to help restore native knee kinematics by stabilizing the medial condyle while allowing lateral translation. It is suitable for use with or without the posterior cruciate ligament (PCL), said Corin.

The company said Unity Knee has been used in more than 75,000 surgical cases since its 2012 launch. Corin claimed that the system has demonstrated some of the best performance across the U.K. and Australian implant registries and that it is committed to growing the brand.

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Unity Knee MC compatible with ApolloKnee robot

The Unity Knee MC Insert is manufactured with ECiMa bearing technology, a vitamin E-enriched, highly cross-linked polyethylene that provides low wear characteristics, oxidative stability, and enhanced mechanical performance. As part of the Unity Knee system, it is compatible with ApolloKnee, Corin’s next-generation robotic-assisted surgical platform.

“Studies have demonstrated that a balanced joint has a greater impact on total knee replacement outcomes than component alignment alone.” stated Christopher Plaskos, Ph.D. and vice president of global clinical innovation at Corin.

“Combining Unity Knee MC with the robotic soft tissue-balancing capabilities of ApolloKnee, a new level of natural joint kinematics and stability can be achieved throughout the range of motion,” he added. “We believe this will provide patients with a more natural-feeling knee.”

“ApolloKnee provides an objective, dual-compartment, sensing and tensing balance assessment prior to bone resections, allowing surgeons to optimize knee function in real-time,” said Corin. “The combination of advanced implant design and unique robotic-assisted balancing aims to improve patient outcomes and satisfaction.”

Corin plans to continue expanding product line

“With the recent 510(k) clearances of the Unity Knee MC and PS-C Tibial Inserts, we’re expanding the range of solutions for surgeons to achieve personalized dynamic knee balance,” said Jim Pierrepont, global franchise lead at Corin. “These advancements reflect our ability to respond quickly to market needs while delivering high-quality innovations.”

“We’re also anticipating further clearances in the coming months, which will strengthen our implant, Apollo, and CorinConnect digital portfolios,” he said. “With our agile R&D pipeline, we remain committed to providing differentiated solutions that enhance patient outcomes.”

The Unity Knee MC Tibial Insert is exclusively available in the U.S. through a limited market release.

The company said its combination of robotics, artificial intelligence, and data to plan, implement and learn, along with clinically proven implants, is intended to deliver improved outcomes and maximize value for patients, surgeons and healthcare providers.