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stryker orthopaedics rfid instrumentation
Howmedica Osteonics
Summary: The Stryker Orthopaedics RFID Instrumentation by Howmedica Osteonics is a Class 2 medical device used primarily in orthopedic procedures to track surgical instruments. It is typically used by orthopedic surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K053348 ↗
Decision Date
August 4, 2006
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The Stryker Orthopaedics RFID Instrumentation was cleared through the FDA 510(k) pathway on August 4, 2006. Manufactured by Howmedica Osteonics, it is classified as a Class 2 device under product code HAW.
What It Is
This device is an RFID-based system designed to track and manage surgical instruments during orthopedic procedures. It uses radio-frequency identification technology to ensure that all instruments are accounted for before, during, and after surgery. This helps reduce the risk of retained surgical items and enhances surgical efficiency.
Clinical Applications
The Stryker Orthopaedics RFID Instrumentation is commonly used in orthopedic surgeries, such as joint replacements and fracture repairs. It is particularly useful in high-volume surgical centers where instrument tracking is critical. This device aids in maintaining surgical inventory and ensuring patient safety by preventing retained instruments.
Indications for Use
The device is indicated for use in tracking surgical instruments during orthopedic procedures. It is suitable for surgeries where precise instrument management is crucial, such as in complex joint replacements or trauma surgeries.
Practical Considerations
The RFID system is compatible with a wide range of surgical instruments typically used in orthopedic procedures. It requires minimal setup and integrates seamlessly into existing surgical workflows. Clinicians should ensure that all instruments are tagged correctly to maximize the system's effectiveness.
Frequently Asked Questions
What is Stryker Orthopaedics RFID Instrumentation used for?
It is used to track and manage surgical instruments during orthopedic procedures to enhance efficiency and safety.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in hospital operating rooms.
What are the FDA-cleared indications?
It is indicated for tracking surgical instruments during orthopedic surgeries to prevent retained items and improve surgical workflow.
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.