US-based medical device company Zimmer Biomet has secured the US Food and Drug Administration (FDA) 510(k) approval for its Persona Revision SoluTion Femur.
Persona Revision SoluTion Femur is a knee implant component designed for patients with metal sensitivities.
The device provides alternatives for those affected by metal hypersensitivity, a condition that can lead to inflammatory responses and implant complications.
It is part of the company’s broader Persona Revision Knee System and has been in clinical use for over seventeen years.
Zimmer Biomet plans to commercialise the Persona Revision SoluTion Femur in the US in the third quarter of this year.
Zimmer Biomet Knees president Joe Urban said: “We are pleased to expand our proprietary surface-hardening technology into the revision knee space with FDA clearance of the Persona Revision SoluTion Femur, the first metal alternative option for those with certain metal sensitivities.
“We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (nickel, cobalt, and chromium).
“Metal sensitivity is one of the potential causes of revision procedures, and the Persona Revision SoluTion Femur is yet another innovation that delivers on our commitment to solve the most meaningful challenges in musculoskeletal health.”
The Persona Revision SoluTion Femur is made from Tivanium (Ti-6Al-4V) alloy, and incorporates a unique surface-hardening treatment to enhance wear performance.
The alloy undergoes the Ti-Nidium Surface Hardening Process, which results in enhanced hardness and wear performance, reducing the risk of particle release.
The system provides surgeons with a range of anatomical components, including tibial and femoral cones with various stem options, to address zonal fixation needs.
Zimmer Biomet is offering the implant in standard and plus sizes to address flexion instability and soft tissue balancing, while minimising implant overhang.
Earlier this year, Zimmer Biomet agreed to acquire Paragon 28 for an equity value of around $1.1bn and an enterprise value of up to $1.2bn.
