Exactech Announces FDA 510(k) Clearance of the TriVerse™ Primary Knee Replacement System

November 4, 2022 |

2 min read

Exactech announced today 510(k) clearance from the U.S. Food and Drug Administration to market the TriVerse™ primary knee system.

GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc., a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced today 510(k) clearance from the U.S. Food and Drug Administration to market the TriVerse™ primary knee system.

The TriVerse primary knee system is designed to accommodate surgical efficiency in hospitals and surgery centers alike, offering cruciate retaining, anterior stabilized and posterior stabilized constructs. Additionally, the TriVerse insert bearings will be exclusively available in highly crosslinked vitamin E-stabilized polyethylene.

Exactech’s Chief Marketing Officer and Senior Vice President of Large Joints 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 launch with a compact set of adjustable mechanical instrumentation, with future compatibility planned with the company’s flagship ExactechGPS® system.

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

The new system will add to the company’s portfolio of knee solutions, which includes its balanced knee system, award-winning primary and revision implants and instruments and fully integrated GPS platform.

TriVerse will be in limited launch starting in Q2 2023. Visit www.exac.com/knee/ for more information about Exactech’s knee replacement products.

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, Vumedi, YouTube, Instagram and Twitter.

ExactachGPS is manufactured by Blue Ortho, a subsidiary of Exactech, and distributed by Exactech, Inc. TriVerse is a distributed product. For full product information, please visit https://www.signatureortho.com.au/.