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acufex tag r bioabsorbable anchors
Acufex Microsurgical
Summary: The Acufex Tag R Bioabsorbable Anchors are used in surgical procedures to secure soft tissue to bone. They are typically used by orthopedic surgeons in settings such as hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K946346 ↗
Decision Date
April 26, 1995
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The Acufex Tag R Bioabsorbable Anchors were cleared via the FDA 510(k) pathway on April 26, 1995. Manufactured by Acufex Microsurgical, this device is classified as a Class 2 medical device.
What It Is
The Acufex Tag R Bioabsorbable Anchors are surgical devices designed to attach soft tissue to bone. Made from bioabsorbable materials, these anchors gradually dissolve in the body, eliminating the need for removal surgery. They are commonly used in orthopedic procedures, particularly in joint repairs such as shoulder or knee surgeries.
Clinical Applications
These anchors are frequently utilized in orthopedic surgeries, such as rotator cuff repairs or ACL reconstructions. They are used in hospital operating rooms and ambulatory surgical centers by orthopedic surgeons. The device is suitable for patients requiring soft tissue fixation to bone, often seen in sports injuries or degenerative joint conditions.
Indications for Use
The FDA indications suggest that the Acufex Tag R Bioabsorbable Anchors are intended for use in procedures where soft tissue needs to be securely attached to bone. This is applicable in cases like tendon repairs or ligament reconstructions.
Practical Considerations
The anchors come in various sizes to accommodate different surgical needs and anatomical considerations. They are compatible with standard orthopedic surgical techniques and instruments. Surgeons should be familiar with the bioabsorbable nature of the material, which affects the long-term outcomes of the procedure.
Frequently Asked Questions
What is Acufex Tag R Bioabsorbable Anchors used for?
They are used to attach soft tissue to bone in orthopedic surgeries, such as rotator cuff or ACL repairs.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for securing soft tissue to bone, commonly in tendon and ligament repairs.
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.