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Acufex Arthroscope
Acufex Microsurgical
Summary: The Acufex Arthroscope is a surgical device used primarily for arthroscopic procedures. It is FDA 510k cleared and linked to studies on suture fixation techniques and shoulder instability repairs.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K934270 ↗
Decision Date ?
February 14, 1994
Product Code ?
HRX
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Arthroscope was cleared through the FDA 510k pathway on February 14, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Arthroscope is a medical device designed for minimally invasive surgical procedures, particularly in orthopedic applications. It allows clinicians to visualize and operate within joints using small incisions.
FDA-Cleared Indications
- Use as an arthroscope for endoscopic visualization of the interior of a joint during orthopedic surgery.
- Use with compatible arthroscopic instruments to support minimally invasive diagnosis and treatment of intra-articular conditions.
Clinical Applications
- Arthroscopic visualization of joint structures during orthopedic procedures.
- Visualization during arthroscopic fracture fixation and suture-based repair when the device is used within its cleared system and labeling.
- Visualization during arthroscopic repair of shoulder instability when performed with compatible instruments and according to the device labeling.
Evidence Summary
The available literature includes 10 studies, ranging from retrospective analyses to randomized controlled trials, conducted between 1997 and 2014. These studies explore various surgical techniques and outcomes associated with the device.
Reported Outcomes
Published studies report successful outcomes in arthroscopic suture fixation of tibial eminence fractures and shoulder instability repairs. The device has been shown to facilitate effective tissue fixation and stabilization in these contexts.
Safety Profile
Reported complications include the risk of pneumothorax from overpenetration during arthroscopic procedures. Other studies did not report significant adverse events, indicating a generally favorable safety profile.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and safety across diverse patient populations.
Practical Considerations
- The arthroscope is used through a small portal or incision and requires compatible light-source, camera, irrigation, and visualization equipment.
- Available viewing angles, diameters, and working lengths depend on the specific model; users should confirm specifications before surgery.
- Clean, disinfect, sterilize, and handle the device according to the manufacturer’s instructions for use. Reusable and single-use components may have different processing requirements.
- MRI safety is model-specific and is not established from the FDA record alone. Do not bring the device into an MRI environment unless its labeling confirms that it is MR Safe or MR Conditional.
- Contraindications and precautions depend on the planned procedure, patient anatomy, infection status, bleeding risk, and the instruments used with the arthroscope.
Frequently Asked Questions
What are the clinical indications for Acufex Arthroscope?
The Acufex Arthroscope is indicated for use in arthroscopic procedures such as suture fixation of fractures and shoulder instability repairs.
What outcomes have been reported in clinical studies?
Studies report effective outcomes in fracture fixation and shoulder stabilization, with successful tissue fixation and stabilization.
What complications have been reported?
Safety data indicate a risk of pneumothorax from overpenetration during procedures, though other studies report minimal adverse events.
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.