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stryker navigation system infinitus hip resurfacing module
Stryker
Summary: The Stryker Navigation System Infinitus Hip Resurfacing Module is a surgical navigation tool used in hip resurfacing procedures. It aids orthopedic surgeons in precisely aligning and positioning implants.
FDA Clearance Information
Pathway
510K
Number
K072271 ↗
Decision Date
December 18, 2007
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The Stryker Navigation System Infinitus Hip Resurfacing Module was cleared via the FDA 510(k) pathway on December 18, 2007. It is manufactured by Stryker and classified as a Class 2 device.
What It Is
The Stryker Navigation System Infinitus Hip Resurfacing Module is a sophisticated surgical navigation system designed to assist surgeons during hip resurfacing procedures. It provides real-time, three-dimensional imaging and guidance to enhance the precision of implant placement. This system is particularly useful in ensuring accurate alignment and positioning, which can improve surgical outcomes and implant longevity.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in hip resurfacing procedures. It is utilized in both hospital and specialized orthopedic surgical centers. The primary patient population includes individuals with hip joint degeneration who are candidates for hip resurfacing rather than total hip replacement. Surgeons use this system to achieve optimal implant positioning, which is crucial for patient mobility and implant durability.
Indications for Use
The FDA indications for this device include its use in hip resurfacing surgeries. It is intended for patients with hip joint issues such as osteoarthritis, where preserving bone and achieving precise implant placement is critical.
Practical Considerations
Clinicians should be aware of the system's compatibility with various implant types and sizes. Proper training in the navigation system is essential to maximize its benefits. The system requires a stable setup in the operating room to ensure accurate imaging and guidance.
Frequently Asked Questions
What is the Stryker Navigation System Infinitus Hip Resurfacing Module used for?
It is used to assist surgeons in accurately aligning and positioning implants during hip resurfacing procedures.
What specialties typically use this device?
Orthopedic surgeons specializing in hip surgeries, particularly those performing hip resurfacing, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in hip resurfacing surgeries to aid in the precise placement of implants.
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.