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acufex cannulated screws washers bone plates
Acufex Microsurgical
Summary: Acufex Cannulated Screws Washers Bone Plates are orthopedic devices used for internal fixation in bone surgeries. They are primarily used by orthopedic surgeons to stabilize fractures and aid in bone healing.
FDA Clearance Information
Pathway
510K
Number
K890641 ↗
Decision Date
February 27, 1989
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Acufex Cannulated Screws Washers Bone Plates were cleared via the FDA 510k pathway on February 27, 1989. Manufactured by Acufex Microsurgical, this Class 2 device is designed for orthopedic surgical applications.
What It Is
The Acufex Cannulated Screws Washers Bone Plates are orthopedic devices used to stabilize bone fragments during the healing process. Cannulated screws allow for precise placement over guide wires, while washers distribute pressure and plates provide structural support. These components are crucial in surgeries requiring internal fixation to ensure proper alignment and healing of bones.
Clinical Applications
These devices are commonly used in orthopedic surgeries, particularly in trauma cases involving fractures. They are essential in procedures such as open reduction and internal fixation (ORIF) to treat fractures in various bones, including long bones like the femur and tibia. Orthopedic surgeons in hospital and surgical center settings frequently utilize these devices for patients with traumatic injuries or conditions requiring bone stabilization.
Indications for Use
The FDA indications for these devices involve their use in stabilizing fractures and aiding in bone healing. They are suitable for patients with fractures requiring surgical intervention to ensure proper alignment and stabilization during the healing process.
Practical Considerations
These devices come in various sizes to accommodate different anatomical needs and fracture types. Compatibility with other surgical instruments and implants is crucial for successful outcomes. Surgeons should be familiar with the technique of using cannulated screws over guide wires for precise placement.
Frequently Asked Questions
What is Acufex Cannulated Screws Washers Bone Plates used for?
They are used for stabilizing fractures and aiding in the healing process during orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons commonly use these devices in trauma and fracture repair surgeries.
What are the FDA-cleared indications?
These devices are indicated for use in stabilizing bone fractures and supporting bone healing.
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.