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american orthopaedic vacuum 0295-250
Martin Medical
Summary: The American Orthopaedic Vacuum 0295-250 is a medical device used primarily in prostate-artery-embolization procedures. Key evidence highlights its role in managing soft tissue defects and infections.
FDA Clearance Information
Pathway
510K
Number
K861073 ↗
Decision Date
March 28, 1986
Product Code
LGF
Device Class
Class 1
Evidence
0 studies
The American Orthopaedic Vacuum 0295-250 was cleared by the FDA via the 510k pathway on March 28, 1986. It is manufactured by Martin Medical and classified as a Class 1 device.
What It Is
The American Orthopaedic Vacuum 0295-250 is a vacuum-assisted closure device designed for use in orthopedic procedures, particularly in managing soft tissue defects and promoting wound healing. It is intended for use in clinical settings requiring controlled negative pressure therapy.
Clinical Applications
Commonly used in prostate-artery-embolization, this device is also applied in scenarios involving wound management and infection control, such as treating calcaneal osteomyelitis and postoperative infections.
Evidence Summary
The available literature includes a range of study types such as RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2023 to 2025, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report the device's efficacy in managing soft tissue defects and infections, particularly in combination with other treatments like antibiotic-loaded calcium sulphate. The device has shown positive outcomes in wound healing and infection control.
Safety Profile
Reported complications include potential failure in infection control when used alone, as highlighted in studies of postoperative spine surgical site infections. The device is generally well-tolerated when used in combination with other treatments.
Evidence Limitations
The evidence is limited by the small number of studies directly focusing on the device's standalone efficacy. Further research is needed to explore long-term outcomes and comparative effectiveness against other treatment modalities.
Frequently Asked Questions
What are the clinical indications for American Orthopaedic Vacuum 0295-250?
The device is indicated for use in prostate-artery-embolization and managing soft tissue defects and infections.
What outcomes have been reported in clinical studies?
Studies have reported positive outcomes in wound healing and infection control, particularly when used with adjunctive therapies.
What complications have been reported?
Safety data indicate potential complications in infection control when used alone, with better outcomes when combined with other treatments.
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.