Zimmer Biomet (NYSE:ZBH) today announced it has obtained 510(k) clearance from the FDA for its Persona SoluTion porous plasma spray femur. This innovative knee implant component provides a beneficial option for individuals who are sensitive to traditional bone cement and/or metals. The design incorporates a porous coating for cementless attachment and employs a unique surface treatment aimed at enhancing durability.
Based in Warsaw, Indiana, Zimmer Biomet highlighted that certain patients struggle with metal hypersensitivity when using conventional cobalt-chrome (Co-Cr-Mo) alloy knee replacement implants. Such hypersensitivity can lead to inflammation, discomfort, and implant failure, frequently necessitating a revision of the total knee replacement (TKR).
The Persona SoluTion PPS femur offers a cementless attachment using its validated PPS coating. This coating ensures initial stability and promotes bone growth for long-term fixation. When paired with the Persona OsseoTi tibia and Vivacit-E crosslinked polyethylene (HXLPE), the knee implant reduces the risk of metal sensitizers that trigger immune reactions.
Zimmer Biomet has crafted this component from their proprietary Tivanium (Ti-6Al-4V) alloy, which has over 17 years of clinical history. It’s further strengthened with their Ti-Nidium surface hardening technology.
The company announced in their press release plans to commercially debut this product in the first quarter of 2025.
“Receiving FDA clearance for the Persona SoluTion PPS femur, when used with our Persona OsseoTi tibia and OsseoTi Patella, enables us to deliver a completely cementless alternative to cobalt-chrome implants,” said Joe Urban, who leads the Knees division at Zimmer Biomet. “The adaptability and clinical reliability of our Persona Knee System is enhanced further by this groundbreaking solution, which aids surgeons in addressing the challenges of bone cement sensitivity and metal hypersensitivity that can lead to revision surgeries.”