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osteonics microsurfaced cdh hip stem
Stryker
Summary: The Osteonics Microsurfaced CDH Hip Stem by Stryker is a hip implant used in orthopedic surgeries, specifically for hip replacement. It is primarily used by orthopedic surgeons to treat patients with hip joint issues.
FDA Clearance Information
Pathway
510K
Number
K920250 ↗
Decision Date
April 20, 1992
Product Code
JDI
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 20, 1992. It is manufactured by Stryker and classified as a Class 2 device under product code JDI.
What It Is
The Osteonics Microsurfaced CDH Hip Stem is a prosthetic component used in total hip arthroplasty (THA). It is designed to replace the femoral component of the hip joint. The microsurfaced design aims to enhance osseointegration and stability within the femoral canal, providing a durable solution for patients requiring hip replacement.
Clinical Applications
This hip stem is commonly used in total hip replacement surgeries, often performed in orthopedic settings. It is suitable for patients with severe hip arthritis, fractures, or other degenerative hip conditions. The device is typically used in hospitals or specialized orthopedic centers, catering to adult and elderly populations who require hip joint reconstruction.
Indications for Use
The device is indicated for patients needing hip joint replacement due to conditions like osteoarthritis, rheumatoid arthritis, or traumatic injury. It is designed to restore mobility and alleviate pain in patients with compromised hip joints.
Practical Considerations
The Osteonics Microsurfaced CDH Hip Stem is available in various sizes to accommodate different patient anatomies. Surgeons should consider compatibility with other hip replacement components and ensure proper surgical technique to optimize outcomes.
Frequently Asked Questions
What is the Osteonics Microsurfaced CDH Hip Stem used for?
It is used for total hip replacement surgeries to treat conditions such as osteoarthritis or hip fractures.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries commonly use this device.
What are the FDA-cleared indications?
It is indicated for hip joint replacement in patients with arthritis, fractures, or other degenerative hip conditions.
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.