The cementless method relies on bone growth to secure the implant. A U.K. registry study of more than 33,000 recipients of the Oxford device found implant survival at 10 years after surgery was 94.1%. The average for all other partial knees was 89.9%.
Zimmer received premarket approval (PMA) from the Food and Drug Administration after completing an investigational device exemption study to validate the safety and effectiveness of the device. The PMA notice says the device is intended for patients “whose clinical condition would benefit from a shorter surgical time compared to the cemented implant.”
The company will provide FDA-required training as part of its U.S. launch focused on the cementless surgical technique and proper patient selection. A study of the U.K. registry data found the benefits of cementless procedures are most pronounced when performed by high-caseload surgeons.