Zimmer Biomet receives FDA premarket approval for Oxford cementless partial TKR implant
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Key takeaways:
- Zimmer Biomet received FDA premarket approval for its Oxford cementless partial knee replacement implant.
- The implant first launched in England in 2004.
- The U.S. launch is expected in the first quarter of 2025.
Zimmer Biomet Holdings Inc. announced it received FDA premarket application supplement approval in the U.S. for its Oxford cementless partial knee replacement implant, according to a company press release.
“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,” Joe Urban, president of knees at Zimmer Biomet, said in the release. “We are excited to address the unmet U.S. demand for a cementless partial knee with a new offering which has 20 years of clinical experience in more than 50 countries.”
The Oxford implant is indicated for patients with osteoarthritis or avascular necrosis who are undergoing unilateral partial knee replacement of the medial compartment without the application of cement, according to the release. The implant is not indicated for use in patients undergoing partial knee replacement of the lateral compartment, patients with ligament deficiencies or patients undergoing bilateral surgery.
“For younger and more active patients, the Oxford cementless partial knee amplifies the benefit of a traditional partial knee replacement by offering knee flexion that resembles natural knee movement, and stronger adhesion of the implant to the bone for better long-term durability," Adolph V. Lombardi Jr., MD, FACS, orthopedic surgeon and president of Joint Implant Surgeons Inc., said in the release. “In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation.”
The Oxford cementless partial knee implant initially launched in England in 2004, according to the release. Zimmer Biomet plans to launch the implant in the first quarter of 2025.
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