Zimmer Biomet receives FDA 510(k) clearance for cementless TKR implant
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Key takeaways:
- Zimmer Biomet announced FDA clearance of its Persona solution porous plasma spray femur implant for knee replacement.
- The implant is a cementless option for patients who are sensitive to cement or metal.
Zimmer Biomet Holdings Inc. announced it received FDA 510(k) clearance of its Persona solution porous plasma spray femur implant for total knee replacement, according to a company press release.
The Persona solution porous plasma spray (PPS) femur is designed with a porous coating and offers surgeons a cementless options for TKR in patients who are sensitive to cement or metal, according to the release.
“With the FDA clearance of Persona solution PPS femur, in combination with our Persona OsseoTi tibia and OsseoTi patella, we are proud to offer surgeons a fully cementless alternative to cobalt-chrome implants,” Joe Urban, president of knees at Zimmer Biomet, said in the release. “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. The 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.”
Zimmer Biomet plans for a commercial launch of the implant in the first quarter of 2025, according to the release.
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