đź“Š Evidence-Based Reference
Zenith Pedicle System
Apollo Spine
Summary: The Zenith Pedicle System by Apollo Spine is a device used in spinal surgeries, primarily for stabilization. Key evidence includes studies comparing its outcomes with other stent-grafts.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102636 ↗
Decision Date ?
March 3, 2011
Product Code ?
MNH
Device Class ?
Class 2
Evidence ?
35 studies
The Zenith Pedicle System was cleared by the FDA through the 510(k) pathway on March 3, 2011. It is manufactured by Apollo Spine and classified as a Class 2 device.
What It Is
The Zenith Pedicle System is a spinal stabilization device designed to provide support and alignment in spinal surgeries. It is intended for use in procedures requiring pedicle screw fixation.
FDA-Cleared Indications
- Use for spinal stabilization with pedicle screw fixation.
- Use during spinal fusion or reconstruction procedures when fixation of the vertebral pedicles is indicated.
Clinical Applications
- Posterior spinal fixation using pedicle screws.
- Stabilization of the spine during spinal fusion procedures.
- Maintenance of spinal alignment after surgical correction of instability or deformity.
- Use with compatible spinal fixation components according to the device labeling.
Evidence Summary
The available literature includes four studies, primarily focusing on outcomes and comparisons with other stent-grafts. These studies are registered on clinical trial databases but lack detailed published results.
Reported Outcomes
Published studies report varying outcomes when comparing the Zenith Pedicle System with other stent-grafts. However, specific efficacy findings are not detailed in the available evidence.
Safety Profile
Reported complications include general risks associated with spinal surgeries, but specific adverse events related to the Zenith Pedicle System are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of detailed published results and specific data on the Zenith Pedicle System. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The system includes components selected to match the patient’s anatomy and the planned spinal level; available sizes and configurations must be confirmed in the current manufacturer labeling.
- It should be used only with compatible components and with the surgical instrumentation specified by the manufacturer.
- MRI safety depends on the exact implanted components and the conditions in the current labeling. Confirm MR Safe, MR Conditional, or contraindicated status before scanning.
- Contraindications and precautions may include active infection, inadequate bone quality, allergy or sensitivity to implant materials, and inability to tolerate spinal surgery.
- Implant performance depends on surgical technique, bone healing, patient activity, and follow-up; the system does not replace treatment of the underlying spinal disorder.
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 are the clinical indications for Zenith Pedicle System?
The device is indicated for use in spinal stabilization procedures, particularly in cases of instability or deformity.
What outcomes have been reported in clinical studies?
The studies provide limited information, with general outcomes related to spinal stabilization but lacking specific efficacy data.
What complications have been reported?
Safety data is limited, with general surgical risks noted but no specific complications detailed for the Zenith Pedicle System.
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.