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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation and stabilization of bone fractures using orthopaedic wire.
- Use in fracture fixation techniques such as tension-band wiring and cerclage wiring, according to the specific device labeling.
Clinical Applications
- Tension-band fixation of selected fractures.
- Cerclage fixation around fractured bone or bone fragments.
- Stabilization of fracture fragments during healing.
- Adjunct fixation during orthopaedic fracture repair when specified by the device labeling.
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.
Practical Considerations
- Wire diameter, length and configuration must match the bone, fracture pattern and fixation technique.
- The wire is typically used with compatible orthopaedic implants or instruments and must be handled to avoid kinking, excessive bending or surface damage.
- MRI safety depends on the wire material, dimensions, implant configuration and the specific device labeling; confirm conditions before scanning.
- Potential complications include infection, wire migration or breakage, soft-tissue irritation, loss of fixation and the need for removal.
- Contraindications and precautions include active infection at the operative site, inadequate bone quality or an inability to follow postoperative restrictions; the treating orthopaedic surgeon should assess each case.
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.