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stainless steel orthopaedic cable system
Richards Medical
Summary: The stainless steel orthopaedic cable system by Richards Medical is primarily used for fracture fixation. Key evidence highlights its biomechanical stability compared to alternative materials.
FDA Clearance Information
Pathway
510K
Number
K875156 ↗
Decision Date
January 20, 1988
Product Code
JDQ
Device Class
Class 2
Evidence
0 studies
The stainless steel orthopaedic cable system was cleared by the FDA via the 510(k) pathway on January 20, 1988. It is manufactured by Richards Medical and classified as a Class 2 device.
What It Is
The stainless steel orthopaedic cable system is designed for use in orthopaedic surgeries to provide stabilization and fixation of fractures. It operates by encircling and compressing bone fragments to facilitate healing.
Clinical Applications
This device is commonly used in scenarios requiring fracture fixation, such as in periprosthetic femur fractures and tendon repair procedures. It provides a robust solution for maintaining bone alignment during the healing process.
Evidence Summary
The literature includes 10 studies, ranging from biomechanical evaluations to systematic reviews, conducted between 2016 and 2025. These studies compare the device's performance with alternative materials in various models.
Reported Outcomes
Published studies report that the stainless steel orthopaedic cable system demonstrates superior biomechanical stability compared to non-metallic alternatives. It is noted for its high tensile strength and resistance to elongation under cyclic loading conditions.
Safety Profile
Reported complications include potential for metal fatigue and breakage under extreme conditions. However, no significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is primarily based on ex vivo and cadaveric models, which may not fully replicate in vivo conditions. Further clinical trials are needed to validate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for stainless steel orthopaedic cable system?
The device is indicated for use in fracture fixation and stabilization in orthopaedic surgeries.
What outcomes have been reported in clinical studies?
Studies report high tensile strength and stability, with better performance compared to non-metallic alternatives.
What complications have been reported?
Safety data indicates potential for metal fatigue and breakage, though no significant adverse events were reported in the studies.
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.