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system ten model 100 surgery syst orthopaedic use
Advanced Osseous Technologies
Summary: The System Ten Model 100 is an orthopaedic surgical system by Advanced Osseous Technologies, cleared by the FDA. Key evidence includes 15 studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K905451 ↗
Decision Date
March 5, 1991
Product Code
JDX
Device Class
Class 2
Evidence
0 studies
The System Ten Model 100 was cleared via the FDA 510(k) pathway on March 5, 1991. It is manufactured by Advanced Osseous Technologies and classified as a Class 2 device under product code JDX.
What It Is
The System Ten Model 100 is a surgical system designed for orthopaedic use. It facilitates precise surgical interventions in orthopaedic procedures, enhancing operative efficiency and outcomes.
Clinical Applications
Commonly used in orthopaedic surgeries, the System Ten Model 100 assists in procedures requiring high precision and control. It is particularly valuable in complex surgical scenarios where enhanced accuracy is critical.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series. These studies span from 2024 to 2026, providing a broad overview of the device's clinical applications.
Reported Outcomes
Published studies report limited specific outcomes directly related to the System Ten Model 100. The evidence provided does not detail efficacy findings specific to this device, indicating a need for further targeted research.
Safety Profile
Reported complications include a lack of specific safety data directly associated with the System Ten Model 100. The evidence does not provide detailed adverse event information, highlighting an area for further investigation.
Evidence Limitations
The current evidence lacks detailed outcomes and safety data specific to the System Ten Model 100. There is a need for more focused research to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for System Ten Model 100?
The clinical indications are detailed in the FDA documentation, primarily focusing on orthopaedic surgical applications.
What outcomes have been reported in clinical studies?
Specific outcomes related to the System Ten Model 100 are not detailed in the provided evidence, indicating a gap in the literature.
What complications have been reported?
Safety data specific to the System Ten Model 100 is not detailed in the provided evidence, suggesting a need for further research.
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.