đź“‹ FDA Reference

zenith femoral stem zenith distal centralizer fomoral head acetabular insert

Tgm Medical

Summary: The Zenith Femoral Stem is a hip replacement component used in orthopedic surgeries, specifically for total hip arthroplasty. It is primarily used by orthopedic surgeons to restore hip function in patients with hip joint damage.

FDA Clearance Information

Pathway 510K
Decision Date October 24, 2012
Product Code LPH
Device Class Class 2
Evidence 35 studies

The Zenith Femoral Stem was cleared through the FDA 510(k) pathway on October 24, 2012, by Tgm Medical. It is classified as a Class 2 medical device under product code LPH.

What It Is

The Zenith Femoral Stem is a component of a hip replacement system designed to replace the femoral part of the hip joint. It works by being implanted into the femur, providing a stable base for the femoral head and allowing for articulation with the acetabular component. This device is crucial in restoring mobility and reducing pain in patients with severe hip joint damage.

Clinical Applications

This device is commonly used in total hip arthroplasty procedures, particularly in patients with osteoarthritis, rheumatoid arthritis, or traumatic hip injuries. It is typically utilized in orthopedic surgical settings by orthopedic surgeons. The target patient population includes adults and elderly patients who require hip joint replacement due to degenerative joint diseases.

Indications for Use

The FDA indications for the Zenith Femoral Stem include its use in patients who need hip joint replacement due to conditions like osteoarthritis or hip fractures. It is intended for individuals who have experienced significant hip joint damage and require surgical intervention to restore function.

Practical Considerations

The Zenith Femoral Stem comes in various sizes to accommodate different patient anatomies. It is compatible with other components of the hip replacement system, such as the femoral head and acetabular insert. Surgeons should consider the patient's bone quality and anatomy when selecting the appropriate size and type of stem.

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

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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 Femoral Stem used for?

The Zenith Femoral Stem is used in total hip replacement surgeries to replace the femoral part of the hip joint.

What specialties typically use this device?

Orthopedic surgeons typically use this device in surgical settings for hip replacement procedures.

What are the FDA-cleared indications?

The device is indicated for use in patients needing hip joint replacement due to conditions like osteoarthritis or hip fractures.

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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