đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Attachment and fixation of soft tissue to bone during orthopedic surgery.
- Fixation of ligaments or tendons to the tibia when stable bone-to-soft-tissue fixation is required.
Clinical Applications
- Tibial fixation during anterior cruciate ligament reconstruction.
- Fixation of a ligament or tendon to the tibia during repair or reconstruction.
- Soft-tissue-to-bone fixation in orthopedic procedures involving the knee.
Practical Considerations
- The screw and spiked washer must be selected and positioned according to the patient's anatomy, the tissue being fixed, and the surgical technique.
- The device is intended for use with compatible orthopedic instruments and should be placed with appropriate alignment and tissue tension.
- The FDA record identifies this as a Class II device under product code HWC; the available record does not specify the full range of sizes or materials.
- MRI safety cannot be determined from the available FDA summary. MRI conditions should be confirmed from the current device labeling or manufacturer documentation before scanning.
- Potential complications are related to fixation surgery and may include infection, bleeding, tissue or bone injury, fixation failure, implant migration, pain, and the need for revision surgery.
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.