đź“Š Evidence-Based Reference
orthopaedic wires
Acu Med
Summary: Orthopaedic wires by Acu Med are used in fracture fixation and stabilization. Cleared by FDA in 1994, they are supported by 15 studies highlighting their efficacy in tension band wiring and cerclage applications.
FDA Clearance Information
Pathway
510K
Number
K942603 ↗
Decision Date
November 9, 1994
Product Code
LRN
Device Class
Class 2
Evidence
0 studies
The orthopaedic wires by Acu Med were cleared through the FDA 510(k) pathway on November 9, 1994. They are classified as Class 2 devices under product code LRN.
What It Is
Orthopaedic wires are medical devices used for the fixation and stabilization of bone fractures. They function by converting tensile forces into compressive forces, aiding in bone healing and early mobilization.
Clinical Applications
Commonly used in tension band wiring for upper extremity fractures and cerclage wiring for periprosthetic fractures, orthopaedic wires provide stability and promote healing in various fracture types.
Evidence Summary
The literature includes 15 studies ranging from 2016 to 2023, covering various study types such as RCTs, prospective, and retrospective studies. These studies explore the efficacy and applications of orthopaedic wires.
Reported Outcomes
Published studies report that orthopaedic wires are effective in providing stability for fracture fixation, particularly in tension band and cerclage applications. They are noted for reducing periosteal stripping and being cost-effective compared to other methods.
Safety Profile
Reported complications include mechanical failure and potential for wire migration. However, these events are relatively rare and often manageable with proper surgical technique.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and comparative effectiveness with newer fixation technologies.
Frequently Asked Questions
What are the clinical indications for orthopaedic wires?
Orthopaedic wires are indicated for fracture fixation and stabilization, particularly in tension band and cerclage applications.
What outcomes have been reported in clinical studies?
Studies report effective fracture stabilization, reduced periosteal stripping, and cost-effectiveness in tension band and cerclage applications.
What complications have been reported?
Reported complications include mechanical failure and wire migration, though these are relatively rare with proper technique.
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.