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interface acetabular system acetabular insert 4 offset
Omni Life Science
Summary: The Interface Acetabular System Acetabular Insert 4 Offset by Omni Life Science is a component used in hip arthroplasty. It is primarily used to address acetabular defects and improve prosthetic stability. Key evidence highlights its biomechanical efficacy and wear resistance.
FDA Clearance Information
Pathway
510K
Number
K101976 ↗
Decision Date
September 14, 2010
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 14, 2010. It is manufactured by Omni Life Science and classified as a Class 2 device under product code LPH.
What It Is
The Interface Acetabular System Acetabular Insert 4 Offset is designed for use in hip arthroplasty procedures. It serves to replace or augment the acetabular component of the hip joint, providing stability and reducing the risk of dislocation.
Clinical Applications
This device is commonly used in total hip arthroplasty, particularly in cases involving acetabular defects or instability. It is suitable for both primary and revision surgeries, offering a solution for patients with degenerative hip conditions.
Evidence Summary
The literature includes 11 studies, encompassing a range of study types such as RCTs and retrospective analyses, published between 2018 and 2025. These studies evaluate biomechanical performance, wear characteristics, and clinical outcomes.
Reported Outcomes
Published studies report that the Interface Acetabular System Acetabular Insert 4 Offset demonstrates effective biomechanical stability and reduced wear compared to conventional polyethylene inserts. The device is associated with improved prosthetic positioning and reduced dislocation risk.
Safety Profile
Reported complications include potential dislocation and wear-related issues, although the use of cross-linked polyethylene has been shown to mitigate some of these risks. No significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively short follow-up periods in some studies. Further research is needed to assess long-term outcomes and the impact of different surgical techniques on device performance.
Frequently Asked Questions
What are the clinical indications for Interface Acetabular System Acetabular Insert 4 Offset?
The device is indicated for use in total hip arthroplasty, particularly in cases with acetabular defects or instability, and is suitable for both primary and revision surgeries.
What outcomes have been reported in clinical studies?
Studies report effective biomechanical stability, reduced wear, and improved prosthetic positioning, contributing to a lower risk of dislocation.
What complications have been reported?
Reported complications include potential dislocation and wear-related issues, though cross-linked polyethylene has been shown to reduce these risks.
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.