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synthes 3 5mm quadrilateral surface plates
Synthes (Usa)
Summary: The Synthes 3.5mm Quadrilateral Surface Plates are orthopedic implants used for fracture fixation in the quadrilateral surface of the pelvis. They are typically used by orthopedic surgeons in trauma settings.
FDA Clearance Information
Pathway
510K
Number
K093928 ↗
Decision Date
March 29, 2010
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Synthes 3.5mm Quadrilateral Surface Plates were cleared through the FDA 510(k) pathway on March 29, 2010. Manufactured by Synthes (USA), this device is classified as a Class 2 medical device under product code HRS.
What It Is
The Synthes 3.5mm Quadrilateral Surface Plates are specialized orthopedic implants designed for use in the stabilization of fractures in the quadrilateral surface of the pelvis. These plates are made from biocompatible materials and are designed to conform to the complex anatomy of the pelvic region, providing stable fixation to facilitate proper healing. The plates are used in conjunction with screws to secure the fractured bone segments.
Clinical Applications
These plates are commonly used in orthopedic trauma surgery, particularly in cases involving complex pelvic fractures. They are employed in hospital settings, often in trauma centers, where orthopedic surgeons perform procedures to stabilize fractures and ensure proper alignment of the pelvic bones. The device is particularly useful in adult patients who have sustained high-impact injuries, such as those from motor vehicle accidents or falls.
Indications for Use
The FDA-cleared indications for this device include the fixation of fractures in the quadrilateral surface of the pelvis. This means it is used in patients who have sustained pelvic fractures that require surgical intervention to stabilize the bone and promote healing.
Practical Considerations
The Synthes 3.5mm Quadrilateral Surface Plates are available in various lengths to accommodate different fracture patterns and patient anatomies. They are compatible with standard orthopedic screws, and surgeons should be familiar with the specific surgical techniques required for pelvic fracture fixation. Proper preoperative planning and imaging are essential to ensure optimal outcomes.
Frequently Asked Questions
What is Synthes 3.5mm Quadrilateral Surface Plates used for?
These plates are used for the fixation of fractures in the quadrilateral surface of the pelvis, providing stability to facilitate healing.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in trauma surgery, use this device in hospital and trauma center settings.
What are the FDA-cleared indications?
The device is indicated for the fixation of fractures in the quadrilateral surface of the pelvis.
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.