📊 Evidence-Based Reference
the progressive orthopaedic company total knee system ii
The Progressive Orthopaedic
Summary: The Total Knee System II by The Progressive Orthopaedic is a knee replacement device cleared by the FDA. It is primarily used for knee osteoarthritis. Key evidence highlights its role in improving joint function.
FDA Clearance Information
Pathway
510K
Number
K183344 ↗
Decision Date
March 18, 2019
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The Total Knee System II was cleared by the FDA via the 510(k) pathway on March 18, 2019. It is manufactured by The Progressive Orthopaedic and classified as a Class 2 device under product code JWH.
What It Is
The Total Knee System II is an orthopedic implant designed for total knee arthroplasty. It aims to restore knee function and alleviate pain in patients with severe knee osteoarthritis.
Clinical Applications
This device is commonly used in total knee replacement surgeries for patients with advanced osteoarthritis who have not responded to conservative treatments. It is intended to improve mobility and reduce pain.
Evidence Summary
The available literature includes 8 studies, comprising various study types such as RCTs and case series, with publication years ranging from 2021 to 2024. These studies explore the device's efficacy and safety.
Reported Outcomes
Published studies report improvements in knee joint function and pain relief following the use of the Total Knee System II. Quantitative susceptibility mapping and T1 ρ mapping have been used to assess cartilage health post-implantation.
Safety Profile
Reported complications include potential for retear in associated procedures and stress shielding effects. However, specific adverse events related to the Total Knee System II are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed long-term safety data and specific outcomes related to the Total Knee System II. Further research is needed to evaluate long-term efficacy and potential complications.
Frequently Asked Questions
What are the clinical indications for Total Knee System II?
The device is indicated for total knee arthroplasty in patients with severe knee osteoarthritis.
What outcomes have been reported in clinical studies?
Studies report improvements in knee joint function and pain relief, with assessments using advanced imaging techniques.
What complications have been reported?
Reported complications include potential for retear and stress shielding effects, though specific adverse events for this device are not detailed.
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.