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new era orthopaedics polyscrew pedicle screw system
New Era Orthopaedics
Summary: The New Era Orthopaedics Polyscrew Pedicle Screw System is a spinal fixation device used primarily for stabilizing the spine in various conditions. Key evidence includes studies on spinal deformities and minimally invasive surgery techniques.
FDA Clearance Information
Pathway
510K
Number
K141253 ↗
Decision Date
January 9, 2015
Product Code
MNI
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 9, 2015, by New Era Orthopaedics. It is classified as a Class 2 medical device under product code MNI.
What It Is
The New Era Orthopaedics Polyscrew Pedicle Screw System is a spinal fixation device designed to provide stability to the spine. It is used in surgical procedures to treat spinal deformities and other conditions requiring spinal stabilization.
Clinical Applications
Common clinical scenarios for this device include treatment of spinal deformities such as adolescent idiopathic scoliosis and stabilization in cases of pyogenic spondylodiscitis. It is often used in minimally invasive spinal surgeries.
Evidence Summary
The available literature includes a mix of prospective, retrospective, and other study types, with a total of 5 studies ranging from 2005 to 2022. These studies focus on spinal deformities and surgical techniques.
Reported Outcomes
Published studies report improvements in spinal stability and alignment, particularly in cases of adolescent idiopathic scoliosis and pyogenic spondylodiscitis. Outcomes include restoration of thoracic kyphosis and effective stabilization in minimally invasive procedures.
Safety Profile
Reported complications include potential risks associated with spinal surgery, such as infection and mechanical failure. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically evaluating the device. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for New Era Orthopaedics Polyscrew Pedicle Screw System?
The device is indicated for spinal stabilization in conditions such as spinal deformities and infections requiring surgical intervention.
What outcomes have been reported in clinical studies?
Studies report improved spinal alignment and stability, particularly in adolescent idiopathic scoliosis and pyogenic spondylodiscitis cases.
What complications have been reported?
Safety data from evidence indicate risks typical of spinal surgery, including infection and mechanical failure, though specific device-related complications are not detailed.
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.