đź“‹ FDA Reference
acufex passing pins and surgical wire
Acufex Microsurgical
Summary: Acufex Passing Pins and Surgical Wire are surgical tools used primarily in orthopedic procedures for precise pin placement. They are typically utilized by orthopedic surgeons in both hospital and outpatient surgical settings.
FDA Clearance Information
Pathway
510K
Number
K920621 ↗
Decision Date
May 5, 1993
Product Code
HWQ
Device Class
Class 1
Evidence
0 studies
The Acufex Passing Pins and Surgical Wire were cleared through the FDA 510(k) pathway on May 5, 1993. Manufactured by Acufex Microsurgical, this device is classified as Class 1 under product code HWQ.
What It Is
The Acufex Passing Pins and Surgical Wire are surgical instruments designed for use in orthopedic procedures. These devices facilitate the accurate placement of pins and wires during surgeries, aiding in the stabilization and alignment of bones. The passing pins are typically used in conjunction with other surgical tools to ensure precise surgical outcomes.
Clinical Applications
Commonly used in orthopedic surgeries, these devices are essential in procedures such as fracture fixation and joint stabilization. They are particularly useful in arthroscopic surgeries where precision is crucial. Orthopedic surgeons often use these tools in both hospital operating rooms and specialized outpatient surgical centers.
Indications for Use
The FDA indications suggest that these devices are intended for use in procedures requiring the placement of surgical pins and wires. This is particularly relevant for patients undergoing surgeries for bone fractures or joint issues.
Practical Considerations
The Acufex Passing Pins and Surgical Wire come in various sizes to accommodate different surgical needs. They are compatible with standard orthopedic surgical instruments. Surgeons should be mindful of the technique to avoid overpenetration, as highlighted in clinical studies.
Related Literature
The linked study investigated the anatomical risks associated with the use of transglenoid pins, specifically noting the potential for pneumothorax if pins overpenetrate the glenoid. The study involved cadaveric shoulders to assess the risk to vital structures. While informative, the study's limitations include its small sample size and focus on a specific anatomical area.
Frequently Asked Questions
What is Acufex Passing Pins and Surgical Wire used for?
These devices are used for precise placement of pins and wires in orthopedic surgeries, aiding in bone stabilization and alignment.
What specialties typically use this device?
Orthopedic surgeons commonly use these devices in both hospital and outpatient surgical settings.
What are the FDA-cleared indications?
The devices are indicated for use in procedures requiring the placement of surgical pins and wires, such as fracture fixation and joint stabilization.
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.