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omni interface acetabular system
Omnlife Science
Summary: The Omni Interface Acetabular System is a modular component used in hip arthroplasty, designed to improve fit and function in joint replacement surgeries. It is primarily used by orthopedic surgeons for patients undergoing hip replacement.
FDA Clearance Information
Pathway
510K
Number
K142201 ↗
Decision Date
January 26, 2015
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The Omni Interface Acetabular System was cleared through the FDA 510(k) pathway on January 26, 2015. It is manufactured by Omnlife Science and classified as a Class 2 device under product code LPH.
What It Is
The Omni Interface Acetabular System is a modular acetabular component used in total hip arthroplasty. It allows for customization of the hip joint replacement, providing surgeons with the ability to tailor the fit and alignment of the implant to the patient's anatomy. This system is part of a broader trend towards modularity in joint replacement, which aims to improve outcomes by allowing for more precise surgical customization.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in total hip arthroplasty procedures. It is suitable for adult patients requiring hip joint replacement due to conditions such as osteoarthritis, rheumatoid arthritis, or traumatic injury. The system is used in both primary and revision hip replacement surgeries, offering flexibility in component selection to match patient-specific anatomical and biomechanical needs.
Indications for Use
The FDA indications suggest that the Omni Interface Acetabular System is intended for use in patients undergoing hip replacement surgery. It is designed to address joint degeneration or damage, providing a modular solution for reconstructing the hip joint.
Practical Considerations
The system offers various sizing options to accommodate different patient anatomies. Surgeons should consider compatibility with other components of the hip replacement system. Proper surgical technique is essential to ensure optimal fit and function, minimizing the risk of complications such as fretting or wear debris.
Related Literature
The linked study examined cases of modular femoral stem-sleeve junction failure in total hip arthroplasty. It highlighted the potential risks associated with modularity, such as fretting and wear debris, which can lead to mechanical failure. The study reported three cases of failure, emphasizing the need for careful consideration of component interfaces during surgery. Limitations include its focus on a specific type of failure and a small sample size.
Frequently Asked Questions
What is the Omni Interface Acetabular System used for?
It is used in total hip arthroplasty to replace the acetabular component of the hip joint, providing a modular and customizable solution for joint reconstruction.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries, particularly those focusing on hip arthroplasty, use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients undergoing hip replacement surgery, addressing joint degeneration or damage.
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.