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Zimmer Biomet receives FDA clearance for cementless TKA solution
Zimmer Biomet Holdings Inc. announced it received FDA 510(k) clearance and CE mark approval for its Persona Trabecular Metal Tibia, a component of the company’s portfolio of cementless total knee arthroplasty solutions.
The Persona Trabecular Metal (TM) Tibia preserves the anatomic benefits of the Persona Tibia design while featuring new drilling, sizing and insertion instrumentation, according to a company press release. A porous biomaterial made from elemental tantalum with structural, functional and physiological properties similar to cancellous bone, the release noted Zimmer Biomet’s TM material has been used in more than 2 million orthopedic devices.
“Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution, furthering our long-standing commitment to enhancing patient experienced and outcomes,” Dan Williamson, group president of joint reconstruction at Zimmer Biomet, said in the release. “We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”
According to the release, the Persona TM Tibia will have a limited launch in the first half of 2018, followed by a full commercial launch in the second half of 2018.
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