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acufex tibial anchor screw spiked washer
Smith & Nephew Endoscopy
Summary: The Acufex Tibial Anchor Screw Spiked Washer is a surgical device used for securing soft tissue to bone, commonly in orthopedic procedures. It is primarily used by orthopedic surgeons in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K961649 ↗
Decision Date
July 16, 1996
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Acufex Tibial Anchor Screw Spiked Washer was cleared through the FDA 510(k) pathway on July 16, 1996. It is manufactured by Smith & Nephew Endoscopy and is classified as a Class 2 device under product code HWC.
What It Is
The Acufex Tibial Anchor Screw Spiked Washer is designed to provide secure fixation of soft tissues to bone, particularly in orthopedic surgeries. It features a screw mechanism with a spiked washer that enhances grip and stability. This device is commonly used in procedures such as ligament repairs and reconstructions, where reliable tissue anchoring is crucial.
Clinical Applications
This device is frequently used in orthopedic surgeries, particularly in procedures involving the knee, such as ACL reconstructions. Orthopedic surgeons utilize it to ensure stable fixation of ligaments or tendons to the tibia. It is suitable for use in both adult and pediatric populations, depending on the specific surgical requirements.
Indications for Use
The Acufex Tibial Anchor Screw Spiked Washer is indicated for use in surgeries requiring the attachment of soft tissue to bone. This includes procedures like ligament repairs, where secure fixation is necessary to facilitate proper healing and function.
Practical Considerations
The device is available in various sizes to accommodate different surgical needs and anatomical considerations. It is compatible with standard orthopedic surgical instruments and techniques. Surgeons should ensure proper alignment and tension during placement to optimize outcomes.
Frequently Asked Questions
What is Acufex Tibial Anchor Screw Spiked Washer used for?
It is used for securing soft tissue to bone in orthopedic surgeries, such as ligament repairs.
What specialties typically use this device?
Orthopedic surgeons commonly use this device in surgical settings.
What are the FDA-cleared indications?
It is indicated for procedures requiring the attachment of soft tissue to bone, such as ligament repairs.
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.