Zimmer Biomet Gets FDA Approval for Cementless Partial Knee

Zimmer Biomet Gets FDA Approval for Cementless Partial Knee

Introduction

Zimmer Biomet announced it has received supplemental FDA premarket approval (PMA) for the Oxford Cementless Partial Knee, making it the only FDA-approved cementless partial knee implant available in the U.S.

FDA investigational device exemption (IDE) study and non-clinical testing

This approval follows safety and efficacy data from an FDA investigational device exemption (IDE) study and non-clinical testing.

Oxford Cementless Partial Knee

The Oxford Cementless Partial Knee offers improved fixation, enhanced long-term implant survival, and increased surgical efficiency compared to its cemented counterpart. Unlike traditional partial knee replacement (PKR), which relies on bone cement for implant stability, the cementless approach enables natural bone growth to secure the implant. This promotes better long-term fixation and stability, according to the company.

Design of the system

Featuring a mobile bearing design, the Oxford system allows the femoral component to move naturally through a full range of motion, providing a more natural feel and improved knee function. The system’s tibial and femoral components are coated with titanium and hydroxyapatite to encourage bone integration into the implant.

Launch in 2025

Zimmer Biomet highlights the system’s 20 years of clinical use globally, with over 300,000 procedures performed in more than 50 countries. The company plans to launch the Oxford Cementless Partial Knee nationwide in the U.S. in early 2025.

What did the company official say?

“Cementless knee replacement procedures are increasingly preferred by surgeons seeking improved surgical efficiency,” said Zimmer Biomet’s President of Knees. “The Oxford Cementless Partial Knee offers a less invasive alternative to total knee replacement, retaining more healthy anatomy and improving outcomes. We’re excited to meet the U.S. demand for this proven technology.”

This innovation is poised to address unmet needs for less invasive and durable knee replacement options, backed by decades of clinical success worldwide.