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zenith plate system anterior spinal instrumentation
Ortho Tec
Summary: The Zenith Plate System is an anterior spinal instrumentation device used in spinal surgeries. It is primarily utilized by orthopedic surgeons and neurosurgeons for spinal stabilization.
FDA Clearance Information
Pathway 510K
Number K001535 ↗
Decision Date March 20, 2001
Product Code KWP
Device Class Class 2
Evidence 35 studies
The Zenith Plate System was cleared through the FDA 510(k) pathway on March 20, 2001. Manufactured by Ortho Tec, it is classified as a Class 2 device under product code KWP.
What It Is
The Zenith Plate System is a spinal instrumentation device designed for anterior stabilization of the spine. It consists of plates and screws that are surgically implanted to provide structural support and facilitate spinal fusion. This system is particularly useful in cases of spinal instability or deformity, offering a robust solution for maintaining spinal alignment.
Clinical Applications
This device is commonly used in spinal surgeries to treat conditions such as degenerative disc disease, spinal fractures, or deformities like scoliosis. It is typically employed in orthopedic and neurosurgical settings, often in hospitals or specialized spine centers. The patient population includes adults with spinal instability requiring surgical intervention.
Indications for Use
The FDA indications suggest that the Zenith Plate System is intended for patients requiring anterior spinal stabilization. This includes conditions where the spine needs support to heal properly, such as after trauma or in degenerative diseases.
Practical Considerations
The system is available in various sizes to accommodate different patient anatomies. It is compatible with standard surgical techniques for anterior spinal fusion. Surgeons should be familiar with the device's instrumentation and ensure proper sizing and placement for optimal outcomes.
Linked Studies (20)
PubMed • 2025
Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft.
Vascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Gingival zenith level, position, and symmetry: A systematic review and meta-analysis.
The Journal of prosthetic dentistry
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Expert-Based Narrative Review on Contemporary Use of an Off-The-Shelf Multibranched Endograft for Endovascular Treatment of Thoracoabdominal Aortic Aneurysms: Device Design, Anatomical Suitability, Technical Tips, Perioperative Care, Clinical Applications, and Real-World Experience.
Annals of vascular surgery
View Source → PubMed • 2024
Exploring atmospheric optical turbulence: observations across zenith angles.
Applied optics
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Gingival Zenith Correction by Laser Gingivectomy.
Cureus
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Retrospective View Source → PubMed • 2023
Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source → PubMed • 2023
Commentary: Data zenith.
The Journal of thoracic and cardiovascular surgery
View Source → PubMed • 2022
Placement of a Zenith® Dissection Endovascular System in the Descending Thoracic Aorta Can Hamper Further Surgical Aortic Operations.
EJVES vascular forum
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
New Technical Approach to Overcome Anatomical Challenges During Branched Endovascular Aortic Repair with off-the-Shelf Multibranched Stent-Grafts: Are We Sequentially and Progressively Scraping the Sky? : Commentary on "Sequential catheterization and progressive deployment of the Zenith tBranchTM device for branched endovascular aortic aneurysm repair".
Cardiovascular and interventional radiology
View Source → PubMed • 2021
Kinematic Zenith Tropospheric Delay Estimation with GNSS PPP in Mountainous Areas.
Sensors (Basel, Switzerland)
View Source → PubMed • 2020
Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2020
Physician-Modified Endograft With Double Inner Branches for Urgent Repair of Supraceliac Para-Anastomotic Pseudoaneurysm.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2019
Device profile of the Zenith Dissection Endovascular System for aortic dissection.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2016
Thoracic endovascular aortic repair for complicated chronic type B aortic dissection in a patient on hemodialysis with recurrent ischemic colitis.
Surgical case reports
Case Series View Source → PubMed • 2015
Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.
Journal of Korean medical science
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2014
Experience of the Zenith Dissection Endovascular System in the emergency setting of malperfusion in acute type B dissections.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Zenith Plate System used for?
It is used for anterior spinal stabilization in surgeries to treat conditions like spinal fractures or degenerative disc disease.
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 anterior stabilization of the spine in cases of instability due to trauma or degenerative conditions.
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.