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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
510K
Number
K953459 ↗
Decision Date
August 23, 1995
Product Code
MBI
Device Class
Class 2
Evidence
0 studies
The Acufex Tag Anchor was cleared by the FDA through the 510(k) pathway on August 23, 1995. It is manufactured by Acufex Microsurgical and is classified as a Class 2 medical device.
What It Is
The Acufex Tag Anchor is a non-metallic suture anchor designed for the secure attachment of soft tissue to bone. It is used in various surgical procedures, particularly in hand surgery, to provide reliable fixation.
Clinical Applications
Commonly used in hand surgery, the Acufex Tag Anchor is employed to attach soft tissues to bone. It is also evaluated in rotator cuff repairs and other orthopedic applications where secure tissue fixation is required.
Evidence Summary
The literature includes six studies, ranging from 1995 to 2004, examining the Acufex Tag Anchor's efficacy and safety. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report successful use of the Acufex Tag Anchor in hand surgery with no failures in soft tissue attachment. Biomechanical studies indicate its strength in rotator cuff repairs, although it may be less robust than other anchors for general orthopedics.
Safety Profile
Reported complications include time-dependent reduction in load to failure for absorbable anchors. No major adverse events were noted in the studies reviewed.
Evidence Limitations
Evidence gaps exist in long-term outcomes and comparative effectiveness with other anchoring systems. Further research is needed to establish its efficacy in broader orthopedic applications.
Frequently Asked Questions
What are the clinical indications for Acufex Tag Anchor?
The Acufex Tag Anchor is indicated for soft tissue attachment to bone, particularly in hand surgery and rotator cuff repairs.
What outcomes have been reported in clinical studies?
Clinical studies report successful soft tissue attachment in hand surgery with no failures. Biomechanical studies show adequate strength for rotator cuff repairs.
What complications have been reported?
Reported complications include a reduction in load to failure over time for absorbable anchors, with no major adverse events noted.
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.