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zimmer unicompartmental knee system vivacit-e articular surface
Zimmer
Summary: The Zimmer Unicompartmental Knee System is an orthopedic implant used for partial knee replacement. It is primarily utilized by orthopedic surgeons to treat patients with knee osteoarthritis affecting a single compartment.
FDA Clearance Information
Pathway
510K
Number
K122529 ↗
Decision Date
November 16, 2012
Product Code
HSX
Device Class
Class 2
Evidence
0 studies
The Zimmer Unicompartmental Knee System was cleared via the FDA 510(k) pathway on November 16, 2012. Manufactured by Zimmer, it is classified as a Class 2 device under product code HSX.
What It Is
The Zimmer Unicompartmental Knee System is a medical device designed for partial knee replacement surgery. It consists of a femoral component, tibial component, and the Vivacit-E articular surface, which is made from a highly cross-linked polyethylene. This system allows for the replacement of only the damaged compartment of the knee, preserving healthy bone and tissue, and potentially leading to a quicker recovery compared to total knee replacement.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in unicompartmental knee arthroplasty (UKA). It is suitable for patients with osteoarthritis confined to a single compartment of the knee, often the medial or lateral compartment. The procedure is typically performed in hospital settings, and the patient population includes adults who have not responded adequately to conservative treatments.
Indications for Use
The FDA indications suggest that this device is intended for patients with knee osteoarthritis affecting only one compartment. It is suitable for those who have sufficient bone stock and intact ligaments, and who are not candidates for total knee replacement.
Practical Considerations
The Zimmer Unicompartmental Knee System comes in various sizes to accommodate different patient anatomies. It is important for surgeons to ensure proper alignment and fit during implantation to optimize outcomes. Compatibility with existing surgical tools and techniques is generally high, but familiarity with unicompartmental procedures is beneficial.
Frequently Asked Questions
What is the Zimmer Unicompartmental Knee System used for?
It is used for partial knee replacement in patients with osteoarthritis affecting a single compartment of the knee.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and arthroplasty procedures commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with knee osteoarthritis confined to one compartment, who have adequate bone stock and intact ligaments.
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.