đź“Š Evidence-Based Reference
progressive orthopaedic total hip system
The Progressive Orthopaedic
Summary: The Progressive Orthopaedic Total Hip System is a medical device used in total hip arthroplasty. It is primarily used for hip replacement surgeries. Key evidence highlights its accuracy in cup placement and feasibility in measuring liner wear.
FDA Clearance Information
Pathway
510K
Number
K143314 ↗
Decision Date
February 27, 2015
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 27, 2015, by The Progressive Orthopaedic. It is classified as a Class 2 device under product code LPH.
What It Is
The Progressive Orthopaedic Total Hip System is designed for use in total hip arthroplasty procedures. It assists in the replacement of the hip joint, providing improved joint function and pain relief for patients with hip joint degeneration.
Clinical Applications
This device is commonly used in patients requiring hip replacement due to conditions such as osteoarthritis, rheumatoid arthritis, or traumatic injury. It is particularly relevant in cases where joint preservation is no longer viable.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from recent years, with the latest being published in 2024.
Reported Outcomes
Published studies report that the device allows for accurate cup placement in total hip arthroplasty and demonstrates feasibility in measuring liner wear using advanced imaging systems. The device is associated with improved surgical precision and patient outcomes.
Safety Profile
Reported complications include typical surgical risks such as infection, dislocation, and wear-related issues. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base is limited by a lack of long-term follow-up studies and comprehensive safety data. Further research is needed to evaluate long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Progressive Orthopaedic Total Hip System?
The device is indicated for use in total hip arthroplasty, particularly in patients with degenerative joint diseases such as osteoarthritis or rheumatoid arthritis.
What outcomes have been reported in clinical studies?
Studies report accurate cup placement and feasibility in measuring liner wear, contributing to improved surgical precision and patient outcomes.
What complications have been reported?
Reported complications include infection, dislocation, and wear-related issues, although specific safety data from the evidence is limited.
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.