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stabil orthopaedic solutions total knee system
Stabil Orthopaedic Solutions
Summary: The Stabil Orthopaedic Solutions Total Knee System is a medical device used in total knee arthroplasty to replace damaged knee joints. It is primarily used by orthopedic surgeons in surgical settings to improve mobility and reduce pain in patients with severe knee joint conditions.
FDA Clearance Information
Pathway
510K
Number
K183225 ↗
Decision Date
February 15, 2019
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The Stabil Orthopaedic Solutions Total Knee System received FDA clearance through the 510(k) pathway on February 15, 2019. Manufactured by Stabil Orthopaedic Solutions, it is classified as a Class 2 medical device under product code JWH.
What It Is
The Stabil Orthopaedic Solutions Total Knee System is an orthopedic implant designed for total knee replacement surgeries. It consists of components that replace the femoral, tibial, and patellar surfaces of the knee joint. The system aims to restore knee function and alleviate pain in patients with severe arthritis or knee damage. Its design allows for improved joint stability and range of motion, making it a critical tool in orthopedic surgery.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, particularly for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. Orthopedic surgeons in hospitals and specialized surgical centers typically perform these procedures. The device is suitable for adult patients experiencing significant knee pain and mobility issues that have not responded to conservative treatments.
Indications for Use
The FDA indications for this device include use in patients requiring a total knee replacement due to severe arthritis or knee joint damage. It is intended for individuals who have not found relief through non-surgical treatments and need surgical intervention to restore knee function.
Practical Considerations
The Stabil Orthopaedic Solutions Total Knee System comes in various sizes to accommodate different patient anatomies. Surgeons should consider the compatibility of the system with existing surgical techniques and ensure proper alignment and fixation during implantation. Preoperative planning and intraoperative adjustments are crucial for optimal outcomes.
Frequently Asked Questions
What is the Stabil Orthopaedic Solutions Total Knee System used for?
It is used for total knee replacement surgeries to alleviate pain and restore function in patients with severe knee joint damage.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring total knee replacement due to severe arthritis or knee joint damage.
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.