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Acufex Tag Anchor
Acufex Microsurgical
Summary: The Acufex Tag Anchor is a non-metallic bone anchor used primarily in soft tissue attachment to bone. Key evidence highlights its use in hand surgery with no reported failures in maintaining attachments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K934867 ↗
Decision Date ?
February 9, 1995
Product Code ?
JDR
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Tag Anchor was cleared by the FDA via the 510(k) pathway on February 9, 1995. It is manufactured by Acufex Microsurgical and classified as a Class II device.
What It Is
The Acufex Tag Anchor is a non-metallic suture anchor designed for soft tissue attachment to bone. It is primarily used in orthopedic procedures to secure soft tissues, such as tendons and ligaments, to bone.
FDA-Cleared Indications
- Soft-tissue attachment to bone during orthopedic surgery.
- Fixation of tendons, ligaments, or other soft tissues where a non-metallic bone anchor is appropriate.
Clinical Applications
- Securing tendon attachments to bone.
- Securing ligament or other soft-tissue attachments to bone.
- Use in hand surgery requiring soft-tissue-to-bone fixation.
- Use in orthopedic procedures where a non-metallic suture anchor is selected.
Evidence Summary
The available literature includes six studies ranging from 1995 to 2004, encompassing various study types such as RCTs and biomechanical studies. These studies explore the anchor's efficacy and mechanical properties.
Reported Outcomes
Published studies report that the Acufex Tag Anchor effectively maintains soft tissue attachment to bone in hand surgery without failures. Biomechanical studies indicate a time-dependent reduction in load to failure for absorbable anchors, while nonabsorbable anchors maintain consistent strength over time.
Safety Profile
Reported complications include suture breakage in nonabsorbable anchors, as observed in biomechanical testing. No clinical studies reported adverse events related to the device's use in hand surgery.
Evidence Limitations
The evidence is limited by the small sample sizes and lack of long-term clinical outcomes. Further research is needed to compare the Acufex Tag Anchor with other anchoring systems in diverse orthopedic applications.
Practical Considerations
- The specific anchor size, suture configuration, and insertion technique should match the anatomy, tissue quality, and surgical procedure.
- Confirm compatibility with the sutures and instruments used for anchor placement before surgery.
- As a non-metallic device, its MRI labeling should be verified in the current product documentation; do not assume it is MRI safe or MRI conditional without that information.
- Potential complications include anchor loosening or migration, failure of soft-tissue fixation, infection, inflammation, bone damage, and the need for revision surgery.
- Contraindications and precautions include infection at the operative site, inadequate bone or soft-tissue quality, and inability to follow postoperative protection and rehabilitation instructions.
Frequently Asked Questions
What are the clinical indications for Acufex Tag Anchor?
The Acufex Tag Anchor is indicated for use in soft tissue attachment to bone, particularly in hand surgery and other orthopedic procedures.
What outcomes have been reported in clinical studies?
Clinical studies report successful maintenance of soft tissue attachments in hand surgery with no failures, and consistent mechanical strength in nonabsorbable anchors.
What complications have been reported?
Safety data from evidence indicates suture breakage in nonabsorbable anchors during biomechanical testing, with no clinical adverse events reported.
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.