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progressive orthopaedic total knee system
The Progressive Orthopaedic
Summary: The Progressive Orthopaedic Total Knee System is a medical device designed for total knee arthroplasty, primarily used to alleviate pain and restore function in patients with severe knee osteoarthritis. Key evidence highlights its widespread use and ongoing improvements in surgical techniques.
FDA Clearance Information
Pathway
510K
Number
K150783 ↗
Decision Date
June 23, 2015
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The Progressive Orthopaedic Total Knee System was cleared by the FDA through the 510(k) pathway on June 23, 2015. It is manufactured by The Progressive Orthopaedic and classified as a Class 2 medical device.
What It Is
The Progressive Orthopaedic Total Knee System is a prosthetic device used in total knee arthroplasty (TKA) procedures. It is intended to replace the knee joint in patients with severe osteoarthritis, providing pain relief and improved joint function.
Clinical Applications
This device is commonly used in patients with moderate-to-severe knee osteoarthritis who have not responded to conservative treatments. It is particularly indicated for those requiring total knee replacement to restore mobility and reduce pain.
Evidence Summary
The available literature includes 14 peer-reviewed studies, encompassing various study types such as RCTs and case series. The studies span from 2022 to 2024, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Progressive Orthopaedic Total Knee System effectively reduces pain and improves function in patients undergoing total knee arthroplasty. The device is associated with high patient satisfaction rates, although some studies note that up to 20% of patients may experience suboptimal outcomes.
Safety Profile
Reported complications include implant survivorship concerns and the need for revision surgeries in some cases. However, the overall safety profile is consistent with other total knee arthroplasty devices.
Evidence Limitations
The evidence base is limited by the lack of long-term follow-up studies and the variability in patient selection criteria across studies. Further research is needed to establish the long-term durability and optimal patient selection for this device.
Frequently Asked Questions
What are the clinical indications for the Progressive Orthopaedic Total Knee System?
The device is indicated for patients with severe knee osteoarthritis requiring total knee replacement to alleviate pain and improve joint function.
What outcomes have been reported in clinical studies?
Studies report effective pain reduction and improved function, with high patient satisfaction, although some patients may experience suboptimal outcomes.
What complications have been reported?
Reported complications include implant survivorship issues and the potential need for revision surgeries.
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.