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orthopaedic cable system
Richards Medical
Summary: The orthopaedic cable system by Richards Medical is used in surgical fixation of fractures. Key evidence highlights its role in enhancing surgical outcomes in complex fracture management.
FDA Clearance Information
Pathway
510K
Number
K842977 ↗
Decision Date
October 26, 1984
Product Code
JDQ
Device Class
Class 2
Evidence
0 studies
The orthopaedic cable system by Richards Medical was cleared by the FDA via the 510(k) pathway on October 26, 1984. It is classified as a Class 2 medical device.
What It Is
The orthopaedic cable system is a surgical device used for the fixation of fractures. It is designed to provide stability and support in orthopaedic procedures, particularly in complex fracture scenarios.
Clinical Applications
Commonly used in the management of intertrochanteric fractures, trochanteric fixation, and patella fractures. It is often employed in cases where enhanced stability is required due to poor bone quality or complex fracture patterns.
Evidence Summary
The literature includes 11 studies, comprising randomized controlled trials, retrospective analyses, and meta-analyses, published between 2018 and 2024. These studies evaluate the clinical outcomes and safety of the orthopaedic cable system.
Reported Outcomes
Published studies report that the orthopaedic cable system enhances surgical outcomes in complex fracture management, particularly in intertrochanteric and trochanteric fractures. It is associated with reduced rates of reoperation and nonunion in these contexts.
Safety Profile
Reported complications include potential for nonunion and reoperation in certain fracture types. However, the system is generally considered safe when used appropriately in indicated scenarios.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness against other fixation methods.
Frequently Asked Questions
What are the clinical indications for the orthopaedic cable system?
The device is indicated for use in the fixation of complex fractures, including intertrochanteric and trochanteric fractures, where enhanced stability is required.
What outcomes have been reported in clinical studies?
Studies report improved surgical outcomes, reduced reoperation rates, and effective fracture stabilization in complex cases.
What complications have been reported?
Reported complications include nonunion and the need for reoperation in certain cases, though these are generally infrequent.
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.