Zimmer Biomet Announces FDA Approval for Innovative Cementless Partial Knee Replacement
Zimmer Biomet Holdings, Inc., a notable leader in medical technology, recently received the Premarket Approval (PMA) Supplement from the U.S. Food and Drug Administration (FDA) for its revolutionary Oxford® Cementless Partial Knee. This approval marks a significant milestone, establishing the Oxford Cementless Partial Knee as the only cementless partial knee replacement implant currently available in the United States.
This groundbreaking implant was developed based on extensive safety and effectiveness data derived from an Investigational Device Exemption (IDE) study alongside non-clinical testing. Its design enhances fixation and efficiency during surgery, allowing for improved long-term survival rates. Over the past 20 years, the Oxford Cementless Partial Knee has gained notable clinical experience, with more than 300,000 procedures performed in various countries, including Canada, Europe, the Middle East, Africa, and Asia.
Joe Urban, President of Knees at Zimmer Biomet, expressed his excitement about this launch, stating, "Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is entering the U.S. market with a proven record of retaining more healthy anatomy through a less invasive approach, leading to better patient outcomes than total knee replacements."
One of the primary advantages of a cementless approach over traditional methods, which deploy bone cement to secure implants, is its tendency to promote natural bone growth for superior long-term fixation. The innovative design boasts a mobile bearing that moves seamlessly with the femoral component, allowing for a more natural range of motion and stability of the implant-to-bone interface. Enhanced by a titanium and hydroxyapatite coating, the implant encourages bone growth, further contributing to its success in long-term fixation. According to data from the UK national joint registry, over 33,000 patients treated with the Oxford Cementless Partial Knees have recorded a remarkable 94.1% rate of implant survival ten years post-surgery—significantly higher than the average survival rate (89.9%) for other partial knee implants.
As the demand for partial knee replacements continues to surge globally, the Oxford Cementless Partial Knee is now positioned to cater to an unmet market need in the U.S. Its unique features amplify the benefits for younger, more active individuals, providing better knee flexion that mimics natural movement along with stronger adhesion of the implant, ensuring improved durability.
Dr. Adolph V. Lombardi Jr., President of JIS Orthopedics in New Albany, Ohio, affirmed the advantages of the cementless approach in his own practice, noting that it has shortened surgery times and reduced costs associated with the preparation of cement. This implant, having launched initially in England back in 2004, has proven to be the favored choice among Zimmer Biomet's European customers.
The company plans to initiate a nationwide launch in the U.S. during the first quarter of 2025, which will include comprehensive training mandated by the FDA. This training will focus on the techniques related to cementless surgery along with patient selection criteria. Currently, the Oxford Partial Knee stands out as the only implant with a lifetime limited warranty covering Zimmer Biomet replacement implants.
Safety information regarding the Cementless Oxford Partial Knee System indicates that it is intended solely for unilateral knee procedures involving osteoarthritis or avascular necrosis confined to the medial compartment. It is not suitable for use in the lateral compartment or for patients with ligament deficiencies or simultaneous bilateral surgeries. Potential risks include loosening, dislocation, fracture, wear, or infection, which could necessitate further surgical intervention. For thorough details on product indications and warnings, consult the associated Product Information for Use (IFU) and Surgical Technique documentation.
For those interested in the Oxford Cementless Partial Knee, more details are available on Zimmer Biomet's official website.
About Zimmer Biomet: Zimmer Biomet continues to be a frontrunner in the global medical technology sector, committed to enhancing mobility and health. The company is absorbed in innovation through a comprehensive product portfolio combined with digital and robotic technologies that leverage data and artificial intelligence. With an impressive 90+ years in the industry, Zimmer Biomet is dedicated to providing top-notch solutions for patients and healthcare providers alike, while continually evolving through innovation.
This groundbreaking implant was developed based on extensive safety and effectiveness data derived from an Investigational Device Exemption (IDE) study alongside non-clinical testing. Its design enhances fixation and efficiency during surgery, allowing for improved long-term survival rates. Over the past 20 years, the Oxford Cementless Partial Knee has gained notable clinical experience, with more than 300,000 procedures performed in various countries, including Canada, Europe, the Middle East, Africa, and Asia.
Joe Urban, President of Knees at Zimmer Biomet, expressed his excitement about this launch, stating, "Cementless knee replacement procedures are increasingly preferred by surgeons seeking to improve surgical efficiency. The Oxford Cementless Partial Knee is entering the U.S. market with a proven record of retaining more healthy anatomy through a less invasive approach, leading to better patient outcomes than total knee replacements."
One of the primary advantages of a cementless approach over traditional methods, which deploy bone cement to secure implants, is its tendency to promote natural bone growth for superior long-term fixation. The innovative design boasts a mobile bearing that moves seamlessly with the femoral component, allowing for a more natural range of motion and stability of the implant-to-bone interface. Enhanced by a titanium and hydroxyapatite coating, the implant encourages bone growth, further contributing to its success in long-term fixation. According to data from the UK national joint registry, over 33,000 patients treated with the Oxford Cementless Partial Knees have recorded a remarkable 94.1% rate of implant survival ten years post-surgery—significantly higher than the average survival rate (89.9%) for other partial knee implants.
As the demand for partial knee replacements continues to surge globally, the Oxford Cementless Partial Knee is now positioned to cater to an unmet market need in the U.S. Its unique features amplify the benefits for younger, more active individuals, providing better knee flexion that mimics natural movement along with stronger adhesion of the implant, ensuring improved durability.
Dr. Adolph V. Lombardi Jr., President of JIS Orthopedics in New Albany, Ohio, affirmed the advantages of the cementless approach in his own practice, noting that it has shortened surgery times and reduced costs associated with the preparation of cement. This implant, having launched initially in England back in 2004, has proven to be the favored choice among Zimmer Biomet's European customers.
The company plans to initiate a nationwide launch in the U.S. during the first quarter of 2025, which will include comprehensive training mandated by the FDA. This training will focus on the techniques related to cementless surgery along with patient selection criteria. Currently, the Oxford Partial Knee stands out as the only implant with a lifetime limited warranty covering Zimmer Biomet replacement implants.
Safety information regarding the Cementless Oxford Partial Knee System indicates that it is intended solely for unilateral knee procedures involving osteoarthritis or avascular necrosis confined to the medial compartment. It is not suitable for use in the lateral compartment or for patients with ligament deficiencies or simultaneous bilateral surgeries. Potential risks include loosening, dislocation, fracture, wear, or infection, which could necessitate further surgical intervention. For thorough details on product indications and warnings, consult the associated Product Information for Use (IFU) and Surgical Technique documentation.
For those interested in the Oxford Cementless Partial Knee, more details are available on Zimmer Biomet's official website.
About Zimmer Biomet: Zimmer Biomet continues to be a frontrunner in the global medical technology sector, committed to enhancing mobility and health. The company is absorbed in innovation through a comprehensive product portfolio combined with digital and robotic technologies that leverage data and artificial intelligence. With an impressive 90+ years in the industry, Zimmer Biomet is dedicated to providing top-notch solutions for patients and healthcare providers alike, while continually evolving through innovation.
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