FDA Clears Zimmer Biomet’s Persona OsseoTi Keel Tibia for Cementless Knee Replacement

Zimmer Biomet Holdings Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Persona OsseoTi Keel Tibia for cementless knee replacement. Persona OsseoTi is the latest addition to the company’s Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet’s OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human cancellous (spongey) bone. This material is combined with a keeled design to deliver stable initial and biological fixation.
 
“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,” Chief Operating Officer Ivan Tornos said. “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. We’re proud to close out the year with another advancement in our portfolio, thanks to the strong execution of our team members and our commitment to fueling growth with innovation.”
 
Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coveragei and 3D printed, porous OsseoTi technology for biological fixation. The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure.
 
“The predicted growth in the prevalence of arthritis in younger, active patients has made cementless total knee arthroplasty an increasingly essential option for surgeons,” said Charles Lawrie, M.D., orthopedic surgeon at Baptist Health Orthopedic Care and clinical associate professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, and a member of the Persona OsseoTi development team. “In addition to the spike-keel design, 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.” 

Zimmer Biomet has a comprehensive portfolio of products and integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. 

Reference
Data on file with Zimmer Biomet: The Persona® OsseoTi® Keel Tibia Provides Strong Initial Fixation. Nov. 2022. 4027.1-GLBL-en