Zimmer Biomet has scored an FDA clearance for a new component of its total knee replacement offering, aimed at patients who may be sensitive to certain metals or bone cement.
The Persona SoluTion Porous Plasma Spray Femur has a permeable coating and a proprietary surface treatment—allowing it to be fixed in place without cement while supporting bony growth around the implant.
“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,” Joe Urban, president of Zimmer Biomet’s knee business, said in a statement.
Exposures to metal can lead to increased inflammatory responses among some patients that have received traditional, cemented knee replacements made of cobalt-chrome alloys, causing pain and an eventual loosening of the implant. Unfortunately, hypersensitivities to metal and bone cement are typically not identified until after undergoing the procedure.
The Persona SoluTion PPS Femur, made of a hardened titanium alloy, is designed to be combined with the company’s Persona OsseoTi tibia and patella, as well as its Vivacit-E polyethylene bearing, to limit the body’s contact with metals such as nickel, cobalt and chromium. Zimmer Biomet said it would commercially launch the femur implant in the first quarter of next year.
In late November, the company also obtained a separate FDA premarket approval for a cementless version of its partial knee replacement, the Oxford.
According to the company, its cementless implant has been placed in more than 300,000 procedures across Canada, Europe, Asia, the Middle East and Africa, after being first launched in England in 2004. Its FDA green light, meanwhile, has made it the first of its type in the U.S.
“Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is coming into the U.S. with a proven track record of retaining more healthy anatomy with a less invasive approach and improved outcomes as compared to a total knee replacement,” said Urban, who joined Zimmer Biomet in October.