đź“‹ FDA Reference
sureshot distal targeting system v4 0 trauma interface
Smith & Nephew
Summary: The Sureshot Distal Targeting System V4.0 is a medical device used in orthopedic surgery to assist in precise targeting during trauma procedures. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K170977 ↗
Decision Date
May 3, 2017
Product Code
OLO
Device Class
Class 2
Evidence
0 studies
The Sureshot Distal Targeting System V4.0, manufactured by Smith & Nephew, was cleared through the FDA 510k pathway on May 3, 2017. It is classified as a Class 2 device under product code OLO.
What It Is
The Sureshot Distal Targeting System V4.0 is an advanced surgical tool designed to enhance accuracy in the placement of screws during orthopedic trauma surgeries. It utilizes electromagnetic technology to provide real-time feedback to the surgeon, reducing the need for repeated imaging and minimizing radiation exposure. This system is particularly beneficial in complex fracture repairs where precision is critical.
Clinical Applications
This device is commonly used in orthopedic trauma settings, particularly in hospitals and surgical centers. It is ideal for procedures involving long bone fractures, such as those of the femur or tibia, where accurate screw placement is crucial. Orthopedic surgeons use this system to improve surgical outcomes and reduce operative time, benefiting a wide range of patients, including those with high-energy trauma injuries.
Indications for Use
The FDA-cleared indications for the Sureshot Distal Targeting System V4.0 include its use in orthopedic surgeries requiring precise targeting for screw placement. It is suitable for patients with fractures requiring internal fixation.
Practical Considerations
The system is compatible with various orthopedic implants and is designed to integrate seamlessly into existing surgical workflows. Surgeons should be familiar with its electromagnetic technology to maximize its benefits. Proper training and calibration are essential for optimal performance.
Frequently Asked Questions
What is the Sureshot Distal Targeting System V4.0 used for?
It is used to assist orthopedic surgeons in accurately placing screws during trauma surgeries, particularly for long bone fractures.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in trauma and fracture repair, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in orthopedic surgeries requiring precise screw placement, particularly in fracture repairs.
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.