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genesis ii xlpe resurfacing patellar components
Smith & Nephew
Summary: The Genesis II XLPE Resurfacing Patellar Components are used in knee arthroplasty procedures to replace or resurface the patella. Orthopedic surgeons typically use this device in patients undergoing knee replacement surgery.
FDA Clearance Information
Pathway
510K
Number
K150241 ↗
Decision Date
October 27, 2015
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The Genesis II XLPE Resurfacing Patellar Components, manufactured by Smith & Nephew, received FDA clearance through the 510(k) pathway on October 27, 2015. It is classified as a Class 2 device under product code JWH.
What It Is
The Genesis II XLPE Resurfacing Patellar Components are medical devices designed for use in knee replacement surgeries. These components are made from highly cross-linked polyethylene (XLPE), which is known for its durability and wear resistance. The device is intended to replace or resurface the patella, or kneecap, to improve joint function and reduce pain in patients with knee joint degeneration.
Clinical Applications
This device is commonly used in total knee arthroplasty (TKA) procedures, particularly in patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the knee. Orthopedic surgeons in hospital settings or specialized orthopedic centers typically perform these procedures. The device is suitable for adult patients who require knee joint resurfacing to restore mobility and alleviate pain.
Indications for Use
The FDA indications for the Genesis II XLPE Resurfacing Patellar Components include use in patients who need knee joint resurfacing due to degenerative conditions like osteoarthritis. It is intended for those undergoing knee replacement surgery to improve joint function and reduce pain.
Practical Considerations
The Genesis II XLPE components are available in various sizes to accommodate different patient anatomies. They are compatible with other components of the Genesis II knee system. Surgeons should be familiar with the specific surgical techniques required for successful implantation and alignment.
Frequently Asked Questions
What is Genesis II XLPE Resurfacing Patellar Components used for?
It is used in knee replacement surgeries to replace or resurface the patella, improving joint function and reducing pain.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement or arthroplasty procedures typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients needing knee joint resurfacing due to degenerative conditions such as osteoarthritis.
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.