đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended to provide organized, sterile surgical instruments and supplies for orthopedic surgical procedures.
- Used when a procedure requires a packaged set of instruments and supplies selected for the planned operation.
Clinical Applications
- Instrument and supply support during orthopedic surgery.
- Preparation for joint replacement procedures.
- Preparation for fracture repair procedures.
- Preparation for ligament reconstruction and other orthopedic operations requiring procedure-specific instruments.
Practical Considerations
- Tray contents, instrument sizes, and quantities vary according to the procedure and the facility's surgical protocol.
- The surgical team should verify that the pack contains the required instruments and is compatible with existing equipment before the procedure.
- Inspect packaging, sterility indicators, expiration information, and instrument condition before use; do not use a damaged or compromised pack.
- These trays are not implants and generally do not have an MRI safety classification as a packaged product. Individual metallic instruments should be managed according to their labeling and institutional MRI-safety policy.
- Use requires appropriate handling, opening, sterilization, and disposal procedures as specified by the manufacturer and facility.
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.