đź“‹ FDA Reference
acufex spiked washer system acufex suture washer system acufex cancellous screw and spiked washer system
Smith & Nephew
Summary: The Acufex Spiked Washer System is a surgical device used primarily in orthopedic procedures to secure soft tissue to bone. It is utilized by orthopedic surgeons in various settings.
FDA Clearance Information
Pathway
510K
Number
K994202 ↗
Decision Date
February 25, 2000
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Spiked Washer System was cleared through the FDA 510(k) pathway on February 25, 2000. Manufactured by Smith & Nephew, it is classified as a Class 2 device.
What It Is
The Acufex Spiked Washer System is a surgical device designed to assist in the fixation of soft tissue to bone. It includes spiked washers and screws that provide secure attachment, often used in ligament repair or reconstruction surgeries. The system is engineered to offer stability and support during the healing process.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in procedures involving ligament repair such as ACL reconstruction. It is suitable for use in both hospital and outpatient surgical settings. The patient population includes individuals requiring surgical intervention for ligament injuries, typically athletes or those with traumatic injuries.
Indications for Use
The FDA-cleared indications suggest that the device is intended for use in securing soft tissue to bone, which is crucial in procedures like ligament reconstruction. It is suitable for patients undergoing surgeries to repair or reconstruct torn ligaments.
Practical Considerations
The Acufex Spiked Washer System is available in various sizes to accommodate different surgical needs and anatomical variations. It is compatible with other orthopedic surgical tools, and proper technique is essential to ensure optimal fixation and patient outcomes.
Frequently Asked Questions
What is the Acufex Spiked Washer System used for?
It is used for securing soft tissue to bone in orthopedic surgeries, such as ligament repair or reconstruction.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for securing soft tissue to bone, particularly in ligament repair or reconstruction surgeries.
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.