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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
510K
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.
Clinical Applications
These pins are commonly used in orthopedic surgeries, such as fracture fixation, bone grafting, and reconstructive procedures. They are utilized in both hospital and outpatient surgical settings. Orthopedic surgeons use these pins for patients requiring stabilization of bone structures, including those with fractures or undergoing corrective surgeries.
Indications for Use
The FDA indications for the Acufex Smooth and Threaded Pins include their use in procedures requiring the fixation of bones or soft tissues. They are suitable for patients needing surgical stabilization of fractures or during reconstructive surgeries.
Practical Considerations
The pins are available in various lengths and diameters to accommodate different surgical needs. They are compatible with standard orthopedic surgical instruments. Surgeons should consider the specific anatomical requirements and choose the appropriate size and type of pin for each procedure.
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.