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smith nephew orthopaedic cabling system
Smith & Nephew
Summary: The Smith & Nephew Orthopaedic Cabling System is a device used for fracture fixation and stabilization in orthopedic surgeries. Key evidence highlights its biomechanical performance and tension maintenance capabilities.
FDA Clearance Information
Pathway
510K
Number
K031162 ↗
Decision Date
May 1, 2003
Product Code
JDQ
Device Class
Class 2
Evidence
0 studies
The Smith & Nephew Orthopaedic Cabling System was cleared by the FDA via the 510(k) pathway on May 1, 2003. It is manufactured by Smith & Nephew and classified as a Class 2 medical device.
What It Is
The Smith & Nephew Orthopaedic Cabling System is designed for use in orthopedic surgeries to provide stabilization and fixation of fractures. It employs a cerclage mechanism to maintain tension and support bone healing.
Clinical Applications
This device is commonly used in scenarios such as fracture fixation, particularly in cases involving interprosthetic femoral fractures and trochanteric fixation. It is also utilized in spinal surgeries for stabilization.
Evidence Summary
The available literature includes five studies ranging from 1997 to 2025, encompassing various study types such as biomechanical assessments and prospective evaluations. These studies focus on the device's mechanical properties and clinical outcomes.
Reported Outcomes
Published studies report that the Smith & Nephew Orthopaedic Cabling System demonstrates effective biomechanical performance in fracture fixation. Improvements in functional and radiologic outcomes have been observed, particularly in trochanteric fixation cases.
Safety Profile
Reported complications include tension loss in cerclage cables and potential for implant breakage. However, third-generation systems have been designed to mitigate these issues, showing improved outcomes in long-term follow-ups.
Evidence Limitations
Current evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Smith & Nephew Orthopaedic Cabling System?
The device is indicated for fracture fixation and stabilization in orthopedic surgeries, including interprosthetic femoral fractures and trochanteric fixation.
What outcomes have been reported in clinical studies?
Studies have reported effective biomechanical performance and improved functional outcomes, particularly in trochanteric fixation cases.
What complications have been reported?
Reported complications include tension loss and potential implant breakage, although newer systems have shown improved safety profiles.
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.