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micro-structured surface hip prosthesis
Osteonics
Summary: The micro-structured surface hip prosthesis by Osteonics is a hip replacement device designed to promote osseointegration. It's used by orthopedic surgeons for patients requiring hip arthroplasty.
FDA Clearance Information
Pathway
510K
Number
K831708 ↗
Decision Date
September 15, 1983
Product Code
—
Device Class
—
Evidence
0 studies
The device was cleared through the FDA 510k pathway on September 15, 1983. Manufactured by Osteonics, it currently does not have a specific product code or class designation.
What It Is
This device is a hip prosthesis featuring a micro-structured surface designed to enhance osseointegration, which is the integration of the implant with the bone. The surface is engineered to facilitate bone ingrowth, providing stable biological fixation without the need for bone cement. This approach is particularly beneficial in younger, more active patients who may require a longer-lasting solution.
Clinical Applications
The micro-structured surface hip prosthesis is commonly used in total hip arthroplasty procedures, particularly in orthopedic settings. It is suitable for patients with degenerative hip diseases such as osteoarthritis or rheumatoid arthritis, as well as those with hip fractures. The device is primarily used by orthopedic surgeons in both hospital and specialized orthopedic clinic settings.
Indications for Use
The FDA indications suggest this device is intended for patients requiring hip replacement due to conditions like arthritis or hip fractures. It is designed to provide a stable and long-lasting solution by promoting bone integration.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with standard surgical techniques for hip arthroplasty. Surgeons should be familiar with the press-fit technique to ensure optimal osseointegration.
Related Literature
The linked study investigated the osseointegration of titanium implants with different surface structures in dogs. It found that micro-structured surfaces, such as those used in this hip prosthesis, promote bone ingrowth and provide strong biomechanical fixation. However, the study was limited by its animal model and may not fully translate to human outcomes.
Frequently Asked Questions
What is the micro-structured surface hip prosthesis used for?
It is used for hip replacement surgeries to treat conditions like osteoarthritis or hip fractures.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in hip arthroplasty procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hip replacement due to degenerative conditions or fractures.
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.