Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for the Persona OsseoTi Keel Tibia.
Warsaw, Indiana-based Zimmer Biomet designed the system for cementless knee replacement. It represents the latest addition to the Persona Knee system platform.
Persona OsseoTi features a new porous version of the Persona anatomic tibia. It includes the Zimmer Biomet OsseoTi porous medical technology. That uses anatomical data with 3D printing technology.
The technology helps to build a structure that directly mimics the architecture of human cancellous (spongey) bone. Combined with a keeled design, it delivers stable initial and biological fixation, according to Zimmer Biomet.
Clearance helps Zimmer Biomet “close out the year” strong
“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 Ivan Tornos, COO at Zimmer Biomet. “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.”
Persona OsseoTi’s anatomic tibia offers less micromotion and optimal bone coverage. It also features a new cemented implant option. Zimmer Biomet said this enables 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 Dr. Charles Lawrie, orthopedic surgeon at Baptist Health Orthopedic Care and Clinical Associate Professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, Florida, 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.”