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empowr porous femur with hanano surfacetm
Encore Medical, L.P.
Summary: The empowr porous femur with hanano surfacetm is a medical device used in orthopedic surgeries, specifically for femoral replacements. It is typically utilized by orthopedic surgeons in procedures involving patients with severe joint damage or degeneration.
FDA Clearance Information
Pathway
510K
Number
K210308 ↗
Decision Date
March 30, 2021
Product Code
MBH
Device Class
Class 2
Evidence
0 studies
The empowr porous femur with hanano surfacetm was cleared via the FDA 510k pathway on March 30, 2021. Manufactured by Encore Medical, L.P., it is classified as a Class 2 device under product code MBH.
What It Is
The empowr porous femur with hanano surfacetm is a femoral implant designed for use in hip replacement surgeries. It features a porous structure that promotes bone ingrowth, enhancing stability and integration with the patient's natural bone. The hanano surface technology further aids in osseointegration, potentially improving long-term outcomes for patients undergoing hip arthroplasty.
Clinical Applications
This device is commonly used in total hip arthroplasty procedures, particularly in patients with osteoarthritis, rheumatoid arthritis, or traumatic joint damage. Orthopedic surgeons in hospital settings frequently employ this implant to restore mobility and alleviate pain in affected patients. It is suitable for a wide range of patients, including those with severe joint degeneration requiring a durable and reliable femoral component.
Indications for Use
The empowr porous femur with hanano surfacetm is indicated for patients requiring hip replacement due to joint diseases like osteoarthritis or rheumatoid arthritis. It is designed to replace the femoral component of the hip joint, providing structural support and improved joint function.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies, ensuring a proper fit during surgery. Surgeons should consider the compatibility of this implant with other components used in hip arthroplasty. Proper surgical technique is crucial to ensure optimal implant positioning and patient outcomes.
Frequently Asked Questions
What is empowr porous femur with hanano surfacetm used for?
It is used in hip replacement surgeries to replace the femoral component of the hip joint.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries use this device.
What are the FDA-cleared indications?
It is indicated for patients needing hip replacement due to conditions like osteoarthritis or rheumatoid arthritis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.