đź“‹ FDA Reference
Osteonics Microsurfaced Cdh Hip Stem
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a femoral component in total hip arthroplasty.
- Use in patients requiring hip joint reconstruction because of degenerative disease, fracture, traumatic injury, or other conditions for which hip replacement is indicated.
Clinical Applications
- Total hip arthroplasty for replacement of the femoral side of the hip joint.
- Hip reconstruction for advanced osteoarthritis or other degenerative hip disease.
- Hip replacement for rheumatoid or inflammatory arthritis when joint reconstruction is indicated.
- Hip replacement after traumatic injury or fracture involving the hip joint.
Practical Considerations
- The stem is one component of a hip replacement system and must be compatible with the selected femoral head, acetabular component, and other system components.
- Multiple sizes may be available; the surgeon selects the size and fixation approach based on the patient's femoral anatomy, bone quality, and surgical plan.
- Implantation requires orthopedic surgery, typically with regional or general anesthesia, sterile handling, and imaging or direct surgical assessment as appropriate.
- MRI safety depends on the complete implant system and its materials. Patients should provide the implant information to the MRI facility before scanning so that conditions for MRI can be verified.
- Contraindications, precautions, and expected implant service life depend on the device labeling, patient factors, fixation method, activity level, and other hip components.
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.