đź“‹ FDA Reference
Acufex Endobutton Pack
Acufex Microsurgical
Summary: The Acufex Endobutton Pack is a surgical device used primarily in orthopedic procedures, particularly for ligament reconstruction. It is utilized by orthopedic surgeons to secure grafts during surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K951859 ↗
Decision Date ?
June 9, 1995
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Endobutton Pack was cleared through the FDA 510(k) pathway on June 9, 1995. Manufactured by Acufex Microsurgical, it is classified as a Class 2 device under product code HRX.
What It Is
The Acufex Endobutton Pack is a surgical device designed for use in ligament reconstruction procedures, such as anterior cruciate ligament (ACL) repair. It functions as a fixation device, providing a secure method for attaching grafts to bone. The device is typically used in minimally invasive arthroscopic surgeries, offering reliable support and stability to the reconstructed ligament.
FDA-Cleared Indications
- Fixation of ligament or tendon grafts during reconstructive orthopedic surgery.
- Use in procedures requiring secure attachment of a soft-tissue graft to bone, including ACL reconstruction.
Clinical Applications
- Femoral fixation of a soft-tissue graft during arthroscopic ACL reconstruction.
- Ligament reconstruction procedures in which a graft must be secured to bone.
- Fixation of tendon or ligament grafts using an arthroscopic surgical technique.
Practical Considerations
- The pack may include components or sizes selected to match the patient's anatomy, graft type and tunnel dimensions.
- Use requires familiarity with the manufacturer's insertion and fixation technique and standard arthroscopic equipment.
- The device is implanted during surgery and should be handled using sterile technique; the specific material and configuration should be confirmed from the product labeling.
- MRI safety should be determined from the exact device materials and current manufacturer labeling. Do not assume that every Endobutton configuration is MRI safe or MRI conditional.
- Contraindications, warnings and limitations are specific to the cleared product configuration and should be reviewed in the FDA labeling and surgical instructions.
Frequently Asked Questions
What is the Acufex Endobutton Pack used for?
It is used for ligament fixation in orthopedic surgeries, particularly ACL reconstruction.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in sports medicine, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in ligament reconstruction procedures, such as ACL repair.
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.