đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Securing soft tissue to bone during orthopedic surgical repair.
- Use in procedures requiring fixation of ligaments, tendons, or other soft tissues to bone.
Clinical Applications
- Fixation of soft tissue to bone during ligament repair.
- Fixation of soft tissue to bone during tendon repair.
- Orthopedic repair procedures involving soft-tissue reattachment to bone.
Practical Considerations
- The appropriate anchor size and configuration depend on the anatomy, tissue quality, repair technique, and surgeon preference.
- The anchor is intended for use with compatible orthopedic instruments and according to the device labeling and surgical technique.
- Bioabsorbable materials gradually break down over time; the resorption period depends on the material and implant characteristics.
- MRI safety should be confirmed from the device-specific labeling or manufacturer records before scanning because the available FDA record does not provide sufficient MRI conditions.
- Contraindications and precautions may include active infection, inadequate bone or soft-tissue quality, and inability to follow postoperative restrictions; the complete labeling should be reviewed.
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.