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acufex tag bioabsorbable anchors
Acufex Microsurgical
Summary: The Acufex Tag Bioabsorbable Anchors are used in surgical procedures to secure soft tissue to bone. They are primarily used by orthopedic surgeons in procedures such as ligament repairs.
FDA Clearance Information
Pathway
510K
Number
K961555 ↗
Decision Date
July 10, 1996
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex Tag Bioabsorbable Anchors were cleared through the FDA 510(k) pathway on July 10, 1996. Manufactured by Acufex Microsurgical, this device is classified as Class 2 under product code JDR.
What It Is
The Acufex Tag Bioabsorbable Anchors are medical devices designed to attach soft tissues, such as ligaments and tendons, to bone. Made from bioabsorbable materials, these anchors gradually dissolve in the body, eliminating the need for surgical removal. This feature is particularly beneficial in reducing long-term complications associated with permanent implants.
Clinical Applications
These anchors are commonly used in orthopedic surgeries, including shoulder, knee, and elbow repairs. They are essential in procedures like rotator cuff repairs and anterior cruciate ligament (ACL) reconstructions. Orthopedic surgeons in both hospital and outpatient settings frequently use these devices to treat athletes and active individuals with soft tissue injuries.
Indications for Use
The FDA-cleared indications for the Acufex Tag Bioabsorbable Anchors involve securing soft tissue to bone in various orthopedic procedures. They are suitable for patients requiring ligament or tendon repair due to injury or degeneration.
Practical Considerations
The anchors come in various sizes to accommodate different anatomical needs and surgical techniques. They are compatible with standard orthopedic instruments, and surgeons should be familiar with bioabsorbable materials and their handling during implantation.
Frequently Asked Questions
What is Acufex Tag Bioabsorbable Anchors used for?
They are used to attach soft tissues like ligaments and tendons to bone during orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons commonly use these anchors in sports medicine and reconstructive surgeries.
What are the FDA-cleared indications?
They are indicated for securing soft tissue to bone in orthopedic procedures, such as ligament and tendon 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.