đź“‹ FDA Reference
Acufex Spiked Washer System Acufex Suture Washer System Acufex Cancellous Screw and Spiked Washer System
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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of soft tissue to bone during orthopedic surgery.
- Use with cancellous screws and spiked washers to provide mechanical fixation of attached soft tissue.
- The specific cleared indication should be confirmed in the device labeling and surgical technique instructions.
Clinical Applications
- Fixation of soft-tissue grafts or ligament attachments to bone when indicated by the surgical technique.
- Use during selected ligament repair or reconstruction procedures, including procedures involving the knee.
- Use in hospital or ambulatory orthopedic operating-room settings by trained surgical personnel.
Practical Considerations
- The system is available in different washer and screw sizes; the surgeon selects components based on anatomy, bone quality, graft or tissue thickness, and the fixation site.
- Correct placement, screw tightening, and seating of the spiked washer are important to avoid tissue damage, loosening, prominence, or inadequate fixation.
- Compatibility should be confirmed between the washer, cancellous screw, instruments, and any graft or suture used during the procedure.
- MRI safety depends on the material and exact implant configuration. The current product labeling should be reviewed before MRI; do not assume the system is MR safe or MR conditional without documentation.
- Potential contraindications and risks include infection, bleeding, neurovascular or soft-tissue injury, loss of fixation, implant prominence, bone damage, allergic reaction, and the need for revision surgery.
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.