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Orthopaedic Polyethylene Cable
Smith & Nephew Richards
Summary: The orthopaedic polyethylene cable by Smith & Nephew Richards is a device used primarily for surgical fixation in orthopaedic procedures. Key evidence highlights its biomechanical stability compared to traditional materials.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K924141 ↗
Decision Date ?
November 30, 1993
Product Code ?
JDQ
Device Class ?
Class 2
Evidence ?
0 studies
The orthopaedic polyethylene cable was cleared by the FDA via the 510(k) pathway on November 30, 1993. It is manufactured by Smith & Nephew Richards and is classified as a Class 2 medical device.
What It Is
The orthopaedic polyethylene cable is a surgical device used in orthopaedic procedures to provide fixation and stabilization. It is designed to replace or augment traditional fixation methods such as stainless steel cerclage wires.
FDA-Cleared Indications
- Fixation and stabilization of fractures during orthopaedic surgery.
- Stabilization of joints or disrupted ligaments during orthopaedic procedures.
- Use as an alternative or adjunct to conventional metallic cerclage wire fixation when indicated by the product labeling.
Clinical Applications
- Cerclage fixation of selected long-bone fractures.
- Fixation or stabilization of patellar fractures.
- Stabilization of selected sternoclavicular joint dislocations.
- Adjunctive fixation during orthopaedic reconstruction when a flexible polyethylene cable is specified.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs, prospective, and retrospective studies, with publication years ranging from 2021 to 2025.
Reported Outcomes
Published studies report that the orthopaedic polyethylene cable provides comparable biomechanical stability to traditional stainless steel wires in fracture fixation. It has been effectively used in patellar tendon reconstruction and sternoclavicular joint stabilization.
Safety Profile
Reported complications include potential issues with fixation stability in certain complex fractures. However, no significant adverse events have been consistently reported across studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety and efficacy profiles across diverse patient populations.
Practical Considerations
- The cable must be selected in a size and configuration appropriate for the anatomy, fracture pattern, and fixation technique.
- It is intended for orthopaedic fixation and should be used with compatible instruments and components specified by the manufacturer.
- Polyethylene is nonmetallic, but the complete implanted construct may include metallic components; MRI safety depends on the entire construct and device-specific labeling.
- The cable should not be used where adequate bone quality, fixation purchase, soft-tissue coverage, or control of infection cannot be achieved.
- Handling, tensioning, knotting, and cutting should follow the manufacturer’s surgical instructions to avoid fraying, loss of fixation, or tissue injury.
Frequently Asked Questions
What are the clinical indications for orthopaedic polyethylene cable?
The device is indicated for use in surgical fixation of fractures and joint stabilization, particularly in cases where traditional metal wires may not be suitable.
What outcomes have been reported in clinical studies?
Studies have reported that the cable provides effective biomechanical stability and is comparable to traditional fixation methods in various orthopaedic applications.
What complications have been reported?
Reported complications include potential fixation stability issues in complex fractures, but no significant adverse events have been consistently noted.
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.