đź“Š Evidence-Based Reference
the progressive orthopaedic total hip system
The Progressive Orthopaedic
Summary: The Progressive Orthopaedic Total Hip System is a total hip arthroplasty device used primarily for hip replacement surgeries. Key evidence highlights its long-term survivorship and application in various patient populations.
FDA Clearance Information
Pathway
510K
Number
K151424 ↗
Decision Date
July 27, 2016
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on July 27, 2016. It is manufactured by The Progressive Orthopaedic and classified as a Class 2 medical device.
What It Is
The Progressive Orthopaedic Total Hip System is designed for total hip arthroplasty, providing a prosthetic solution for hip joint replacement. It utilizes hydroxyapatite coating to enhance implant fixation and longevity.
Clinical Applications
Commonly used in patients requiring hip replacement due to conditions like osteoarthritis, femoral neck fractures, and degenerative arthritis. It is applicable in both primary and revision hip arthroplasty scenarios.
Evidence Summary
The literature includes 15 studies, comprising retrospective analyses, RCTs, and case series, spanning from 2021 to 2025. These studies evaluate the device's efficacy, safety, and cost-effectiveness in various patient populations.
Reported Outcomes
Published studies report long-term survivorship of the device, with hydroxyapatite coating contributing to enhanced implant fixation. The device has shown efficacy in diverse patient groups, including those with Parkinson's disease and hypophosphatemic osteomalacia.
Safety Profile
Reported complications include early postoperative complications in Parkinson's disease patients and potential issues related to implant longevity in younger patients. Overall, the device demonstrates a favorable safety profile.
Evidence Limitations
There is limited data on long-term outcomes beyond 28 years and specific patient subgroups. Further research is needed to assess the device's performance in younger, more active populations and its cost-effectiveness in different healthcare settings.
Frequently Asked Questions
What are the clinical indications for the progressive orthopaedic total hip system?
The device is indicated for total hip arthroplasty in patients with conditions such as osteoarthritis, femoral neck fractures, and degenerative arthritis.
What outcomes have been reported in clinical studies?
Studies report long-term survivorship and effective implant fixation due to hydroxyapatite coating, with positive outcomes in various patient populations.
What complications have been reported?
Reported complications include early postoperative issues in Parkinson's disease patients and concerns about implant longevity in younger patients.
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.