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acufex suretac
Acufex Microsurgical
Summary: The Acufex Suretac is a bioabsorbable device used for soft tissue fixation, primarily in shoulder stabilization procedures. Key evidence highlights its efficacy in arthroscopic repairs, though some complications have been reported.
FDA Clearance Information
Pathway
510K
Number
K931519 ↗
Decision Date
June 16, 1994
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex Suretac was cleared by the FDA through the 510(k) pathway on June 16, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 medical device.
What It Is
The Acufex Suretac is a bioabsorbable fixation device designed for arthroscopic procedures, particularly for soft tissue reattachment to bone. It is commonly used in shoulder stabilization surgeries.
Clinical Applications
The device is frequently utilized in arthroscopic Bankart repairs and SLAP lesion treatments, providing a simplified method for tissue fixation in shoulder instability cases.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, conducted between 2000 and 2006. These studies evaluate the biomechanical performance and clinical outcomes of the Suretac device.
Reported Outcomes
Published studies report that the Acufex Suretac device is effective in stabilizing anterior shoulder lesions and SLAP repairs. Clinical outcomes indicate satisfactory fixation and improved shoulder stability in athletes and general patients.
Safety Profile
Reported complications include foreign-body reactions, device breakage, and early loosening, leading to shoulder pain and reduced mobility in some cases. These issues were observed in a subset of patients undergoing arthroscopic procedures.
Evidence Limitations
The evidence base is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to assess the long-term efficacy and safety of the device across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Acufex Suretac?
The Acufex Suretac is indicated for use in arthroscopic procedures for soft tissue fixation, particularly in shoulder stabilization surgeries such as Bankart repairs and SLAP lesion treatments.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective stabilization of shoulder lesions and satisfactory fixation, resulting in improved shoulder stability and function.
What complications have been reported?
Safety data from evidence indicate complications such as foreign-body reactions, device breakage, and early loosening, which can lead to pain and decreased shoulder mobility.
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.