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navitrack system- partial hip resurfacing universal
Orthosoft
Summary: The Navitrack System is a medical device used for partial hip resurfacing, aiding surgeons in precise navigation during procedures. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K071929 ↗
Decision Date
September 19, 2007
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The Navitrack System by Orthosoft was cleared through the FDA 510(k) pathway on September 19, 2007. It is classified as a Class 2 device under product code HAW.
What It Is
The Navitrack System is a surgical navigation device designed to assist surgeons in performing partial hip resurfacing. It utilizes advanced imaging and tracking technology to provide real-time feedback and enhance surgical precision. This system is particularly useful in aligning and positioning implants accurately, which is crucial for successful hip resurfacing outcomes.
Clinical Applications
The Navitrack System is commonly used in orthopedic surgery settings, particularly in procedures involving partial hip resurfacing. It is beneficial for patients with hip joint issues that require resurfacing rather than total replacement, often seen in younger or more active patients. The system is used in hospitals and specialized orthopedic centers, aiding surgeons in achieving optimal implant placement and alignment.
Indications for Use
The FDA indicates this device for use in partial hip resurfacing procedures. It is intended for patients who need resurfacing due to conditions like osteoarthritis or avascular necrosis, where preserving bone is advantageous.
Practical Considerations
The Navitrack System is compatible with various implant sizes and designs, offering flexibility in different surgical scenarios. Surgeons should be trained in its use to maximize its benefits, and it integrates with standard surgical workflows to enhance precision without significantly extending procedure time.
Frequently Asked Questions
What is the Navitrack System used for?
The Navitrack System is used for assisting in partial hip resurfacing procedures by providing precise navigation and alignment of implants.
What specialties typically use this device?
Orthopedic surgeons specializing in hip surgeries and joint preservation techniques typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in partial hip resurfacing, particularly for patients with conditions like osteoarthritis or avascular necrosis, where bone preservation is beneficial.
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.