Global medical technology leader, Zimmer Biomet Holdings, Inc., has announced that their Persona OsseoTi Keel Tibia cementless knee replacement device has received U.S. Food and Drug Administration 510(k) clearance.
In recent years, cementless knees have revolutionized the orthopedic industry in the United States, forcing businesses without the necessary technology, like Smith & Nephew, to scramble to add the products to their portfolios. Zimmer has been expanding its cementless product line for many years. In 2018, the Persona Trabecular Metal Tibia received FDA certification, and now the company is adding a 3D-printed product to its line-up. The Persona OsseoTi Knee System is the newest addition to the clinically successful Persona Knee System. It includes a new porous variant of the Persona anatomic tibia made with Zimmer Biomet’s OsseoTi Porous Metal Technology, which combines anatomical information with 3D printing to create a framework that closely resembles the design of human cancellous, or spongey, bone. The material is also combined with a keeled design to provide a stable initial fixation and biological fixation.
Zimmer contends that the technology can be utilized for cementless surgeries, but also to allow surgeons to transition to a cemented method until final implantation by utilizing only one instrument tray. “With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless total knee replacement,” said Chief Operating Officer at Zimmer Biomet, Ivan Tornos. “Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application.”
According to Zimmer’s website, the same amount of bone preparation is required for both cementless and cemented treatments, allowing surgeons to choose their preferred method during surgery depending on the patient’s demands and the condition of the patient’s bone. “The Persona OsseoTi Keel Tibia offers the added convenience of a new cemented option with the same bone prep as the cementless option so that surgeons can make an intraoperative decision between a cementless or cemented approach based on bone quality and the unique needs of their patient.”