Zimmer Biomet Receives FDA Approval for Oxford® Cementless Partial Knee

Zimmer Biomet Holdings, Inc. has announced U.S. Food and Drug Administration (FDA) Premarket Approval Application (PMA) Supplement approval for the Oxford^® Cementless Partial Knee. The approval is based on safety and effectiveness data from an Investigational Device Exemption (IDE) study and non-clinical testing for cementless partial knee replacement (PKR).¹ The Oxford Cementless Partial Knee allows surgeons to perform a PKR with improved fixation,² better long-term implant survival rate^2,3 and improved efficiency in the operating room⁴ (OR) compared to the Oxford Cemented Partial Knee procedure.  Following more than 20 years of clinical experience and over 300,000 procedures across Canada, Europe, Middle East, Africa, and Asia,⁵ the Oxford Cementless Partial Knee is now the only FDA-approved cementless partial knee implant 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 outcomes⁶ as compared to a total knee replacement,” said Joe Urban, President, Knees at Zimmer Biomet. “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.⁵“

Compared to traditional partial knee replacements that use bone cement to secure the implant in place, a cementless approach allows patients’ natural bone growth to secure the implant for better long-term fixation.² The Oxford Cementless Partial Knee features a mobile bearing that can move with the femoral component throughout the entire range of motion to mimic natural knee movement. This design provides better range of motion, a more natural feel and a more stable implant-to-bone fixation for improved long-term implant survival.^2,3 The system’s tibial and femoral components have a titanium and hydroxyapatite coating to promote bone growth into the implant⁷. The UK national joint registry has more than 33,000 patients treated with Oxford Cementless Partial Knees recorded with a 94.1% rate of implant survival at 10 years after surgery,³ which is higher than the average 10-year survivorship for all other partial knees (89.9%).³ Enthusiasm and usage of partial knee replacement continues to grow around the world as published research continues to demonstrate that PKR in appropriate cases provides improved patient outcomes compared to TKR.⁶

“For younger and more active patients, the Oxford Cementless Partial Knee amplifies the benefits 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,” said Adolph V. Lombardi Jr., MD, FACS, President of JIS Orthopedics in New Albany, Ohio. “In my own practice, a cementless approach has increased OR efficiency by shortening my surgery time and reducing costs associated with cement preparation.”

Since its initial launch in England in 2004, the Oxford Cementless Partial Knee has become the preferred partial knee implant for Zimmer Biomet’s European customers.⁵

As part of the U.S. nationwide launch in Q1 2025, Zimmer Biomet will provide FDA-required training, focusing on the cementless surgical technique and proper patient selection. For patients in the U.S., the Oxford Partial Knee is the only implant with a lifetime limited warranty that covers the cost of Zimmer Biomet replacement implants.*

Important Safety Information:

The Cementless Oxford Partial Knee System is intended for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant. The Oxford Partial Knee is not indicated for use in the lateral compartment or for patients with ligament deficiency, or for use in simultaneous bilateral surgery or planned staged bilateral procedures. Potential risks include, but are not limited to, loosening, dislocation, fracture, wear and infection, any of which can require additional surgery. 

*Subject to terms and conditions set forth within the written warranty

References:

1. IFU and Surgical Technique for IDE clinical data
2. Mohammad, Hasan R., Andrew Judge, and David W. Murray. “A Matched Comparison of Implant and Functional Outcomes of Cemented and Cementless Unicompartmental Knee Replacements: A Study from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man and the Hospital Episode Statistics Patient Reported Outcome Measures Database.” JBJS 106.17 (2024): 1553-1562.
3. National Joint Registry of England Wales, Northern Ireland, the Isle of Man and Guernsey. 20th Annual Report 2023
4. Pandit, H., et al. “Improved fixation in cementless unicompartmental knee replacement: five-year results of a randomized controlled trial.” JBJS 95.15 (2013): 1365-1372.
5. Internal Data on File: Sales Data November 2024
6. Liddle, A. D., et al. “Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14 076 matched patients from the National Joint Registry for England and Wales.” The bone & joint journal 97.6 (2015): 793-801.
7. Botterill J, Khatkar H. The role of hydroxyapatite coating in joint replacement surgery – Key considerations. J Clin Orthop Trauma. 2022 Apr 22;29:101874. doi: 10.1016/j.jcot.2022.101874. PMID: 35515345; PMCID: PMC9062319.

Source:  Zimmer Biomet Holdings, Inc.