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custom orthopaedic trays packs
Associated Medical Products
Summary: Custom orthopaedic trays packs are pre-packaged sets of surgical instruments and supplies used in orthopedic procedures. They are utilized by surgeons and surgical teams to streamline operations and ensure all necessary tools are readily available.
FDA Clearance Information
Pathway
510K
Number
K930507 ↗
Decision Date
February 22, 1994
Product Code
HTS
Device Class
Class 1
Evidence
0 studies
The custom orthopaedic trays packs by Associated Medical Products were cleared through the FDA 510(k) pathway on February 22, 1994. This device is classified as Class 1 under product code HTS.
What It Is
Custom orthopaedic trays packs are collections of surgical instruments and supplies tailored for specific orthopedic procedures. These trays are designed to provide all necessary tools in a single, sterile package, reducing preparation time and ensuring consistency across procedures. By having a pre-arranged set of instruments, surgical teams can focus more on patient care and less on logistical concerns.
Clinical Applications
These trays are commonly used in orthopedic surgeries such as joint replacements, fracture repairs, and ligament reconstructions. They are particularly beneficial in high-volume surgical settings where efficiency and standardization are critical. Orthopedic surgeons, operating room nurses, and surgical technologists are the primary users, ensuring that all required instruments are available and sterile for each procedure.
Indications for Use
The FDA indications suggest that these trays are intended for use in procedures requiring organized and sterile surgical instruments, particularly in orthopedic surgeries. They help streamline the surgical process by providing a ready-to-use set of tools.
Practical Considerations
Custom orthopaedic trays packs are typically tailored to the specific needs of the procedure, with variations in instrument types and quantities. Compatibility with existing surgical protocols and equipment should be confirmed prior to use. Proper training on the specific tray configuration is recommended to maximize efficiency.
Related Literature
The linked study titled 'Custom Surgical Tray in ACLR Procedure' explores the use of custom trays in anterior cruciate ligament reconstruction (ACLR). Although the abstract is not available, such studies typically assess the impact on surgical efficiency and outcomes. Limitations may include a lack of detailed findings and specific data on clinical outcomes.
Frequently Asked Questions
What is custom orthopaedic trays packs used for?
They are used to provide a pre-packaged, sterile set of instruments and supplies for orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgery teams, including surgeons, nurses, and surgical technologists, commonly use these trays.
What are the FDA-cleared indications?
The trays are indicated for use in orthopedic procedures requiring organized and sterile surgical instruments.
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.