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Advanced Orthopaedic Solutions Trochanteric Nail
Advanced Orthopaedic Solutions
Summary: The Advanced Orthopaedic Solutions Trochanteric Nail is a device used for the fixation of intertrochanteric hip fractures. It is FDA 510k cleared and has been evaluated in several studies, highlighting its efficacy in fracture stabilization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021008 ↗
Decision Date ?
June 20, 2002
Product Code ?
HSB
Device Class ?
Class 2
Evidence ?
0 studies
The Advanced Orthopaedic Solutions Trochanteric Nail was cleared by the FDA through the 510k pathway on June 20, 2002. It is manufactured by Advanced Orthopaedic Solutions and classified as a Class 2 device.
What It Is
The Advanced Orthopaedic Solutions Trochanteric Nail is an intramedullary fixation device designed for the stabilization of intertrochanteric hip fractures. It provides mechanical support to facilitate fracture healing in patients with compromised bone quality.
FDA-Cleared Indications
- Fixation of intertrochanteric fractures of the proximal femur.
- Stabilization of fractures in the trochanteric region using an intramedullary nail.
Clinical Applications
- Surgical fixation of intertrochanteric hip fractures.
- Stabilization of pertrochanteric fractures when the fracture pattern is appropriate for intramedullary fixation.
- Internal fixation of proximal femur fractures in patients with reduced bone quality, when selected by the treating orthopedic surgeon.
Evidence Summary
The available literature includes three studies, ranging from 2021 to 2025, encompassing various study designs such as case series and descriptive reviews. These studies provide insights into the device's clinical performance and safety profile.
Reported Outcomes
Published studies report that the Advanced Orthopaedic Solutions Trochanteric Nail effectively stabilizes intertrochanteric fractures, with a significant proportion of patients returning to their pre-fracture ambulatory status. The device aims to minimize complications such as varus collapse and implant failure.
Safety Profile
Reported complications include peri-implant fractures and anterior cortical perforation. These adverse events highlight the importance of careful surgical technique and patient selection to optimize outcomes.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to compare the device's performance with alternative fixation methods.
Practical Considerations
- The surgeon selects nail length, diameter, and associated fixation components based on the patient's anatomy, fracture pattern, and bone quality.
- Implant compatibility should be confirmed across the nail, screws, blades, and insertion instruments before surgery.
- Placement requires fluoroscopic or other intraoperative imaging guidance and orthopedic surgical technique.
- MRI safety depends on the exact implant materials, configuration, and labeling; the specific device should be checked before an MRI examination.
- Potential contraindications and precautions include active infection, inadequate bone stock, unsuitable anatomy, and medical conditions that make orthopedic surgery or anesthesia unsafe.
Frequently Asked Questions
What are the clinical indications for advanced orthopaedic solutions trochanteric nail?
The device is indicated for the fixation of intertrochanteric and pertrochanteric hip fractures, particularly in patients with osteoporosis.
What outcomes have been reported in clinical studies?
Studies report effective fracture stabilization with many patients returning to their pre-fracture ambulatory status.
What complications have been reported?
Safety data indicate complications such as peri-implant fractures and anterior cortical perforation.
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.