đź“‹ FDA Reference
Acufex Rotator Cuff Fixation Button
Acufex Microsurgical
Summary: The Acufex Rotator Cuff Fixation Button is a surgical device used for the fixation of rotator cuff tears. It is primarily used by orthopedic surgeons in surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K941740 ↗
Decision Date ?
June 30, 1995
Product Code ?
KGS
Device Class ?
Class 1
Evidence ?
0 studies
The Acufex Rotator Cuff Fixation Button was cleared through the FDA 510(k) pathway on June 30, 1995. It is manufactured by Acufex Microsurgical and is classified as a Class 1 device.
What It Is
The Acufex Rotator Cuff Fixation Button is a medical device designed to assist in the surgical repair of rotator cuff injuries. It functions by providing secure fixation of the torn tendon to the bone, facilitating proper healing. The device is typically used in minimally invasive arthroscopic procedures, offering a reliable solution for rotator cuff stabilization.
FDA-Cleared Indications
- Fixation of rotator cuff tears during surgical repair
- Tendon-to-bone fixation in the shoulder
Clinical Applications
- Surgical repair of rotator cuff tears
- Fixation of a repaired rotator cuff tendon to the humeral bone
- Use during open or arthroscopic shoulder surgery when the surgeon determines tendon fixation is required
Practical Considerations
- The surgeon selects the button size and fixation technique based on the tear, tendon quality, bone quality and patient anatomy.
- Placement requires appropriate surgical exposure or arthroscopic access and familiarity with the device-specific technique.
- The record does not provide materials, MRI-conditional labeling or MRI safety information; MRI compatibility should be confirmed in the current manufacturer labeling before scanning.
- Contraindications, warnings, sterilization requirements and handling instructions should be taken from the device's labeling and surgical instructions.
- A fixation button supports tendon repair but does not by itself guarantee tendon healing; rehabilitation and protection of the repair are also important.
Frequently Asked Questions
What is the Acufex Rotator Cuff Fixation Button used for?
It is used for the surgical repair of rotator cuff tears, providing secure fixation of the tendon to the bone.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder surgeries commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with rotator cuff tears requiring surgical repair to restore shoulder function.
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.