FDA clears Zimmer Biomet Knee Implant for metal sensitivity

USA—Zimmer Biomet Holdings, Inc., a global leader in medical technology, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Persona® Revision SoluTion™ Femur.

This innovative revision knee implant component offers a new alternative for patients who have sensitivities to certain metals.

 The Persona Revision SoluTion™ Femur is an integral part of the comprehensive Persona Revision Knee System and incorporates a surface-hardening treatment to improve wear performance.

This system provides surgeons with a variety of anatomical components, including tibial and femoral cones, along with stem choices to facilitate zonal fixation.

Metal hypersensitivity affects a significant portion of the population, with 10% to 15% of the general population and as many as 25% of patients with metallic implants experiencing this issue.

 These patients can develop an immunological reaction to metallic particles, or ions, that are released due to implant wear or corrosion.

Exposure to metals like nickel, cobalt, and chromium, which are commonly used in metal knee implants, can cause inflammatory responses, pain, and implant loosening in individuals with metal hypersensitivities, often requiring total knee replacement revision procedures.

The Persona Revision SoluTion™ Femur addresses this critical issue by being made exclusively from a proprietary Tivanium® (Ti-6Al-4V) alloy that has been clinically used for more than 17 years.

This alloy undergoes a specialized Ti-Nidium Surface Hardening Process, resulting in a strengthened material with hardness comparable to metal implants, along with enhanced wear performance that resists particle release.

 The new revision femur is available in standard and plus sizes, which allows surgeons to address flexion instability and balance soft tissues while minimizing implant overhang.

The Persona Revision SoluTion™ Femur is expected to be commercially available in the U.S. in the third quarter of 2025.

Joe Urban, President, Knees at Zimmer Biomet, expressed enthusiasm about the FDA clearance of the Persona Revision SoluTion™ Femur, noting that it expands their proprietary surface-hardening technology into the revision knee space and provides the first metal alternative option for individuals with certain metal sensitivities.

He also stated that the company is proud to offer a total revision knee construct that avoids the deliberate addition of common metal allergens like nickel, cobalt, and chromium.

Urban further emphasized that metal sensitivity is a potential cause of revision procedures, and the Persona Revision SoluTion™ Femur demonstrates Zimmer Biomet’s commitment to addressing significant challenges in musculoskeletal health.

Zimmer Biomet’s new Persona® Revision SoluTion™ Femur strategically expands their knee revision options, offering a specialized solution that meets a substantial, previously unmet need.

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