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ligafix interface screw
Science For Biomaterials
Summary: The Ligafix Interface Screw is a medical device used primarily in orthopedic surgeries for the fixation of soft tissue to bone. It is commonly utilized by orthopedic surgeons in procedures such as ACL reconstructions.
FDA Clearance Information
Pathway
510K
Number
K090994 ↗
Decision Date
May 6, 2009
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Ligafix Interface Screw was cleared through the FDA 510(k) pathway on May 6, 2009. Manufactured by Science For Biomaterials, it is classified as a Class 2 device under product code HWC.
What It Is
The Ligafix Interface Screw is designed to secure soft tissue, such as ligaments or tendons, to bone. It is typically made of biocompatible materials that integrate well with bone tissue, providing stable fixation. This device is particularly useful in reconstructive surgeries where soft tissue needs to be anchored securely to facilitate proper healing and function.
Clinical Applications
This device is most commonly used in orthopedic surgeries, particularly in sports medicine for procedures like anterior cruciate ligament (ACL) reconstruction. It is also applicable in other ligament repair surgeries, such as rotator cuff repairs. The Ligafix Interface Screw is used in hospital operating rooms and specialized orthopedic clinics, primarily for active patients or athletes who require restoration of joint stability.
Indications for Use
The FDA indications suggest that the Ligafix Interface Screw is intended for use in surgeries where soft tissue needs to be attached to bone. This includes patients undergoing ligament or tendon repair, often due to injury or degenerative conditions.
Practical Considerations
The Ligafix Interface Screw comes in various sizes to accommodate different surgical needs and anatomical variations. It is important to select the appropriate size for optimal fixation. Surgeons should be familiar with the insertion technique to ensure proper placement and stability.
Frequently Asked Questions
What is the Ligafix Interface Screw used for?
The Ligafix Interface Screw is used for securing soft tissue, such as ligaments or tendons, to bone in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in sports medicine and reconstructive surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the fixation of soft tissue to bone, commonly used in ligament and tendon repair 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.