Medical technology firm Zimmer Biomet has received 510(k) clearance for its Persona OsseoTi Keel Tibia from the US Food and Drug Administration (FDA).
The new Persona OsseoTi Keel Tibia has been designed for cementless knee replacement and represents a new addition to the Persona Knee system platform.
It features a new porous version of the Persona anatomic tibia along with the company’s OsseoTi porous metal technology.
The technology leverages anatomical data along with 3D printing technology to build a structure that mimics the human cancellous (or spongey) bone architecture directly.
Zimmer Biomet stated that the combination of this material with a keeled design will offer stable initial and biological fixation.
Zimmer Biomet chief operating officer Ivan Tornos said: “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-centred solution for performing a cementless total knee replacement.
“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.”
Persona OsseoTi also includes an anatomic tibia that offers less micromotion and optimal bone coverage, as well as 3D-printed, porous OsseoTi technology for biological fixation.
Additionally, it features a new cemented implant option, which offers surgeons seamless versatility during the procedure.
In 2020, Zimmer Biomet acquired A&E Medical, a portfolio company of Vance Street Capital, for a total deal value of $250m.