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apex modular acctabular cup now named apex interface acetabular system
Omnlife Science
Summary: The Apex Interface Acetabular System is a modular hip replacement component used in orthopedic surgeries. It is typically utilized by orthopedic surgeons for patients requiring hip joint reconstruction.
FDA Clearance Information
Pathway
510K
Number
K112779 ↗
Decision Date
December 2, 2011
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The Apex Interface Acetabular System was cleared through the FDA 510k pathway on December 2, 2011. Manufactured by Omnlife Science, it is classified as a Class 2 device under product code LPH.
What It Is
The Apex Interface Acetabular System is a modular component used in hip arthroplasty procedures. It serves as the acetabular cup, a critical part of the hip joint replacement, allowing for articulation with the femoral head. The system is designed to provide stability and durability, accommodating various patient anatomies through its modular design.
Clinical Applications
This device is commonly used in total hip replacement surgeries, particularly in patients with degenerative joint diseases such as osteoarthritis or rheumatoid arthritis. It is utilized by orthopedic surgeons in hospital operating rooms and specialized orthopedic centers. The system is suitable for adult patients requiring hip joint reconstruction due to trauma or degenerative conditions.
Indications for Use
The Apex Interface Acetabular System is indicated for patients needing hip joint reconstruction, typically due to conditions like osteoarthritis, rheumatoid arthritis, or hip fractures. It is designed to replace the acetabular part of the hip joint.
Practical Considerations
The system offers various sizing options to fit different patient anatomies. It is compatible with standard surgical techniques for hip arthroplasty. Surgeons should consider the patient's bone quality and anatomy when selecting the appropriate components.
Frequently Asked Questions
What is the Apex Interface Acetabular System used for?
It is used in hip replacement surgeries to replace the acetabular component of the hip joint.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement or reconstructive surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for hip joint reconstruction in patients with conditions like osteoarthritis, rheumatoid arthritis, or hip 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.