Zimmer Biomet has secured the US Food and Drug Administration (FDA) 510(k) clearance for its total knee implant component, Persona SoluTion porous plasma spray (PPS) femur.
It provides an alternative for patients with metal and bone cement sensitivities.
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Persona is a cementless total knee implant option and aims to enhance wear performance through its proprietary surface treatment.
It features a porous coating designed for cementless fixation and addresses the challenges faced by individuals with hypersensitivity to traditional cemented total knee replacements made from cobalt-chrome alloys.
These sensitivities can lead to inflammation, pain, and implant loosening, potentially necessitating a revision surgery.
The implant’s PPS coating has been clinically proven to provide stability that encourages bone ongrowth for biological fixation.
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By GlobalDataZimmer Biomet Knees president Joe Urban said: “With the FDA clearance of Persona SoluTion PPS femur, in combination with our Persona OsseoTi聽Tibia and OsseoTi Patella, we are proud to offer surgeons a fully cementless alternative to cobalt-chrome implants.
“Persona SoluTion PPS Femur combines our latest advances in cementless fixation with decades of proprietary clinical expertise in developing novel materials and surface hardening processes.
鈥淭he utility and versatility of our comprehensive and clinically proven Persona Knee System is further enhanced with the addition of this innovative solution that could help surgeons address two potential causes of revision procedures: sensitivities to bone cement and metal.”
The total knee implant system, when combined with Persona OsseoTi tibia and Vivacit-E highly crosslinked polyethylene (HXLPE), reduces common metal sensitisers that are likely to elicit immune responses.
It is made from tivanium alloy, which undergoes the Ti-Nidium surface hardening process for compatibility with Vivacit-E HXLPE articular surfaces.
Wear performance of the Persona SoluTion PPS Femur, when paired with Vivacit-E, is comparable to that of the Persona cobalt chromium alloy femur with the same bearing.
The implant is set to be available commercially in the US market by the first quarter of next year.
Last month, NeuroOne Medical Technologies amended its agreement with Zimmer Biomet, granting the latter exclusive distribution rights to the OneRF system for an upfront payment of $3m.
