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interface acetabular cup liners
Omni Life Science
Summary: Interface acetabular cup liners by Omni Life Science are used in hip arthroplasty. Key evidence suggests low risk of cup fixation failure at 10 years when used with acetabular component revision.
FDA Clearance Information
Pathway
510K
Number
K092443 ↗
Decision Date
October 23, 2009
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on October 23, 2009. It is manufactured by Omni Life Science and classified as a Class 2 device.
What It Is
Interface acetabular cup liners are components used in hip arthroplasty to provide a bearing surface between the femoral head and the acetabular component. They are intended to improve joint stability and reduce wear.
Clinical Applications
These liners are commonly used in revision total hip arthroplasty, particularly when there is a need to address dislocation risks or improve joint stability. They are often utilized in cases involving acetabular component revision.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2023 and 2025. These studies focus on outcomes related to implant survival and complications.
Reported Outcomes
Published studies report a low risk of cup fixation failure at 10 years when constrained liners are used during acetabular component revision. Dual-mobility constructs have shown promise in reducing dislocation risks in revision THA.
Safety Profile
Reported complications include potential fixation loss at the bone-implant interface and fretting corrosion at the head-neck taper junction. These issues highlight the importance of careful surgical technique and component selection.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the lack of large-scale randomized controlled trials. Further research is needed to assess long-term outcomes and optimize liner design.
Frequently Asked Questions
What are the clinical indications for interface acetabular cup liners?
They are indicated for use in revision total hip arthroplasty to improve joint stability and reduce dislocation risks.
What outcomes have been reported in clinical studies?
Studies report low risk of cup fixation failure and reduced dislocation rates with dual-mobility constructs.
What complications have been reported?
Safety data indicate potential fixation loss and fretting corrosion as complications.
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.