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Medtronic Orthopaedic Trauma Application
Medtronic Navigation
Summary: The Medtronic Orthopaedic Trauma Application is a device used in orthopedic trauma management. It is primarily used for surgical navigation in trauma cases. Key evidence includes studies on fracture risk and growth factor efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050651 ↗
Decision Date ?
July 27, 2005
Product Code ?
HAW
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on July 27, 2005. It is manufactured by Medtronic Navigation and classified as a Class 2 device.
What It Is
The Medtronic Orthopaedic Trauma Application is a surgical navigation system designed to assist clinicians in the precise placement of instruments and implants during orthopedic trauma surgeries. It is intended to improve surgical accuracy and outcomes.
FDA-Cleared Indications
- Used as part of a computer-assisted orthopedic surgical navigation system for orthopedic trauma procedures.
- Provides image-guided or computer-assisted support for planning and guiding instruments during trauma surgery.
- Assists with the placement and alignment of orthopedic implants when navigation is indicated.
Clinical Applications
- Computer-assisted planning of selected orthopedic trauma procedures
- Navigation during complex fracture reduction and fixation
- Guidance for instrument placement during orthopedic trauma surgery
- Assistance with implant alignment and placement in selected fracture procedures
Evidence Summary
The available literature includes 12 studies, comprising meta-analyses and systematic reviews, published between 2025 and 2026. These studies explore fracture risk, growth factor efficacy, and the role of artificial intelligence in spinal cord injury.
Reported Outcomes
Published studies report that a family history of fracture is a significant predictor of future fracture risk, independent of bone mineral density. Additionally, the use of bone morphogenetic protein-2 has been compared to platelet-derived growth factor for nonunion treatment, highlighting potential strategies for promoting healing.
Safety Profile
Reported complications include the general risks associated with surgical navigation systems, such as potential inaccuracies in navigation leading to suboptimal outcomes. However, specific adverse events related to this device were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of direct studies on the Medtronic Orthopaedic Trauma Application itself, with most studies focusing on related clinical factors and treatments. Further research is needed to directly assess the device's efficacy and safety in clinical practice.
Practical Considerations
- This is a software and navigation application used with compatible navigation-system hardware, instruments, imaging data, and orthopedic implants; compatibility must be confirmed before surgery.
- The system does not replace the surgeon's judgment, direct visualization, fluoroscopy, or other imaging when those are clinically necessary.
- Accuracy depends on patient registration, image quality, reference-frame stability, instrument calibration, and avoidance of movement during navigation.
- The application itself is not an implanted device and does not have a permanent implant duration.
- MRI safety depends on the connected hardware, instruments, tracking components, and imaging workflow; the complete system should not be assumed to be MRI safe without reviewing the applicable labeling.
Frequently Asked Questions
What are the clinical indications for Medtronic Orthopaedic Trauma Application?
The device is indicated for use in orthopedic trauma surgeries requiring precise navigation and alignment.
What outcomes have been reported in clinical studies?
Studies report that family history is a significant predictor of fracture risk, and growth factors like BMP-2 may aid in nonunion treatment.
What complications have been reported?
Reported complications include potential inaccuracies in navigation, but specific adverse events were not detailed in the evidence.
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.