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diamondback spinal system

Eminent Spine

Summary: The Diamondback Spinal System is a medical device used in spinal surgeries to stabilize and support the spine. It is primarily used by orthopedic surgeons and neurosurgeons.

FDA Clearance Information

Pathway 510K
Number K100377 ↗
Decision Date April 22, 2010
Product Code MNI
Device Class Class 2
Evidence 19 studies

The Diamondback Spinal System received FDA clearance through the 510(k) pathway on April 22, 2010. It is manufactured by Eminent Spine and classified as a Class 2 device under product code MNI.

What It Is

The Diamondback Spinal System is a spinal stabilization device designed to provide support and alignment to the spine during surgical procedures. It typically consists of rods, screws, and other components that are implanted to stabilize the vertebrae. This system is used to treat conditions such as degenerative disc disease, spinal stenosis, and spondylolisthesis, providing structural support to facilitate healing and pain relief.

Clinical Applications

This device is commonly used in spinal fusion surgeries, where it helps to immobilize and align the vertebrae to promote bone fusion. It is frequently employed in orthopedic and neurosurgical settings, particularly in hospitals and specialized spine centers. Patients who benefit from this device often include those with chronic back pain, spinal deformities, or traumatic spinal injuries.

Indications for Use

The FDA-cleared indications for the Diamondback Spinal System include use in patients requiring spinal stabilization due to conditions like degenerative disc disease or spinal deformities. It is intended for patients who need surgical intervention to correct or stabilize spinal abnormalities.

Practical Considerations

The Diamondback Spinal System comes in various sizes to accommodate different patient anatomies. It is compatible with standard surgical techniques for spinal fusion and stabilization. Surgeons should be familiar with the specific instrumentation and implantation techniques associated with this system.

Linked Studies (19)

PubMed • 2023

Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database.

Cureus

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Initial experience with orbital atherectomy in a tertiary centre in the Netherlands.

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Coronary orbital atherectomy using a five-French guiding catheter.

Cardiovascular intervention and therapeutics

View Source →
PubMed • 2021

Is crossability of the classic crown with the glide assist superior to the micro crown in the Diamondback 360® coronary orbital atherectomy system?

Cardiovascular intervention and therapeutics

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019

Orbital atherectomy for calcified femoropopliteal lesions: a current review.

The Journal of cardiovascular surgery

View Source →
PubMed • 2019

Iliofemoral peripheral orbital atherectomy for optimizing TAVR access: An innovative strategy in the absence of alternative access options.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2018

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

Therapeutic advances in cardiovascular disease

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Quantification by optical coherence tomography imaging of the ablation volume obtained with the Orbital Atherectomy System in calcified coronary lesions.

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Critical hand ischemia treatment via orbital atherectomy-A single center observational retrospective analysis.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treating de novo, severely calcified lesions.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

The American journal of cardiology

View Source →
PubMed • 2015

Orbital atherectomy: device evolution and clinical data.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2014

Cost-effectiveness analysis of orbital atherectomy plus balloon angioplasty vs balloon angioplasty alone in subjects with calcified femoropopliteal lesions.

ClinicoEconomics and outcomes research : CEOR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

Orbital atherectomy for symptomatic lower extremity disease.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease.

Journal of cardiovascular translational research

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Use and abuse of atherectomy: where should it be used?

Seminars in vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2008

Treatment of lower extremity vascular disease: the Diamondback 360 degrees Orbital Atherectomy System.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is the Diamondback Spinal System used for?

It is used for spinal stabilization in surgeries to treat conditions like degenerative disc disease and spinal deformities.

What specialties typically use this device?

Orthopedic surgeons and neurosurgeons commonly use this device in spinal surgeries.

What are the FDA-cleared indications?

The device is indicated for spinal stabilization in patients with conditions such as degenerative disc disease and spinal deformities.

Related Device Categories

Atherectomy Devices
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.

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