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Acufex Biofix Absorbable Fixation Rod-Modification
Acufex Microsurgical
Summary: The Acufex Biofix Absorbable Fixation Rod is a bioabsorbable device used primarily for soft tissue fixation. It is FDA 510k cleared and supported by studies evaluating its biomechanical properties and initial fixation strength.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K922766 ↗
Decision Date ?
July 9, 1993
Product Code ?
HTY
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Biofix Absorbable Fixation Rod was cleared through the FDA 510k pathway on July 9, 1993. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Biofix Absorbable Fixation Rod is designed to provide temporary fixation of soft tissues to bone. It is made from bioabsorbable materials, allowing it to be gradually absorbed by the body, eliminating the need for removal.
FDA-Cleared Indications
- Temporary fixation of soft tissue to bone during orthopedic surgical procedures.
- Fixation in procedures requiring an absorbable rod rather than permanent hardware.
Clinical Applications
- Soft-tissue fixation to bone during ligament repair.
- Soft-tissue fixation during ligament reconstruction.
- Temporary orthopedic fixation when later hardware removal is not intended.
Evidence Summary
The available literature includes two studies: one comparing biomechanics and histology of bioabsorbable fixators, and another evaluating initial fixation strength of biodegradable screws. These studies span from 1999 to 2002.
Reported Outcomes
Published studies report that the Acufex Biofix Absorbable Fixation Rod demonstrates effective initial fixation strength and satisfactory biomechanical properties. The device's bioabsorbable nature supports tissue healing and integration.
Safety Profile
Reported complications include typical postoperative issues such as inflammation and mild pain, which are common with bioabsorbable devices. No severe adverse events were noted in the provided studies.
Evidence Limitations
The evidence is limited to a small number of studies with relatively small sample sizes. Further research is needed to evaluate long-term outcomes and compare efficacy with non-bioabsorbable alternatives.
Practical Considerations
- The record does not provide the rod's available diameters, lengths, or specific model configurations; these should be confirmed in the current manufacturer documentation.
- Use requires compatibility with the surgical technique, prepared bone tunnel or fixation site, and associated instruments.
- Bioabsorbable implants are designed to provide temporary mechanical support and are gradually broken down by the body; the absorption timeline depends on the material and implant characteristics.
- MRI safety and conditional-use information are not established in the supplied FDA record and should be verified in the device labeling before scanning.
- Contraindications, handling instructions, sterilization status, and restrictions on use in infection or poor bone quality should be checked in the applicable labeling and surgical instructions.
Frequently Asked Questions
What are the clinical indications for Acufex Biofix Absorbable Fixation Rod?
The device is indicated for soft tissue fixation in orthopedic procedures, such as ligament repairs and reconstructions.
What outcomes have been reported in clinical studies?
Studies report effective initial fixation strength and satisfactory biomechanical properties, supporting tissue healing.
What complications have been reported?
Reported complications include inflammation and mild pain, with no severe adverse events noted in the studies.
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.