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Acufex Smooth and Threaded Pins
Acufex Microsurgical
Summary: The Acufex Smooth and Threaded Pins are surgical devices used primarily in orthopedic procedures for fixation. They are typically used by orthopedic surgeons in various surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K931836 ↗
Decision Date ?
June 28, 1994
Product Code ?
HTY
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Smooth and Threaded Pins were cleared through the FDA 510(k) pathway on June 28, 1994. Manufactured by Acufex Microsurgical, this device is classified as Class 2 under product code HTY.
What It Is
The Acufex Smooth and Threaded Pins are surgical pins designed for use in orthopedic procedures. They come in smooth and threaded varieties, allowing for versatile applications in bone fixation. These pins are typically made of surgical-grade stainless steel, providing strength and biocompatibility. They are used to stabilize bone fragments or soft tissues during surgical interventions.
FDA-Cleared Indications
- Fixation of bone structures during orthopedic surgical procedures.
- Fixation or stabilization of soft-tissue structures during orthopedic surgical procedures.
- Use in surgical procedures requiring temporary or permanent stabilization with smooth or threaded pins.
Clinical Applications
- Stabilization of bone fragments during fracture-fixation procedures.
- Fixation of bone structures during reconstructive orthopedic surgery.
- Stabilization during bone-grafting procedures.
- Fixation of soft-tissue structures when pin stabilization is required.
- Use in hospital or outpatient orthopedic surgery when the surgeon determines that pin fixation is appropriate.
Practical Considerations
- Pins are available in different lengths and diameters; the surgeon selects the size and smooth or threaded design according to the anatomy and fixation requirements.
- The pins should be used with compatible orthopedic instruments and according to the manufacturer’s instructions for use.
- The record identifies surgical-grade stainless steel, but the exact alloy and MRI conditions should be confirmed in the current labeling before MRI.
- Potential concerns include infection, pin migration or loosening, breakage, soft-tissue irritation, neurovascular injury, and inadequate fixation.
- Contraindications and precautions depend on the specific procedure, implant material, bone quality, infection status, and patient factors.
Frequently Asked Questions
What is Acufex Smooth and Threaded Pins used for?
These pins are used for the fixation of bones or soft tissues in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use these pins in surgical procedures involving bone stabilization.
What are the FDA-cleared indications?
The pins are indicated for use in surgical procedures requiring fixation of bones or soft tissues.
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.