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ascension humeral resurfacing arthroplasty system
Ascension Orthopedics
Summary: The Ascension Humeral Resurfacing Arthroplasty System is designed for shoulder joint resurfacing. It is primarily used in cases of shoulder arthritis. Key evidence includes follow-up studies examining safety and functional outcomes.
FDA Clearance Information
Pathway
510K
Number
K062861 ↗
Decision Date
October 31, 2006
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 31, 2006. It is manufactured by Ascension Orthopedics and classified as a Class 2 device under product code HSD.
What It Is
The Ascension Humeral Resurfacing Arthroplasty System is a surgical device used for resurfacing the humeral head in shoulder arthroplasty. It is intended to restore joint function and alleviate pain in patients with shoulder arthritis.
Clinical Applications
This device is commonly used in patients with degenerative joint disease of the shoulder, particularly those with osteoarthritis or rheumatoid arthritis. It is suitable for patients requiring joint resurfacing without the need for a full shoulder replacement.
Evidence Summary
The available literature includes three studies, focusing on follow-up assessments of the device. These studies are registered on ClinicalTrials.gov, but specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report on the functional outcomes and safety of the Ascension Humeral Resurfacing Arthroplasty System. However, specific efficacy findings are not detailed in the provided evidence.
Safety Profile
Reported complications include general surgical risks associated with shoulder arthroplasty. Specific adverse events or complications are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to provide comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Ascension Humeral Resurfacing Arthroplasty System?
The device is indicated for patients with degenerative joint disease of the shoulder, such as osteoarthritis or rheumatoid arthritis, requiring joint resurfacing.
What outcomes have been reported in clinical studies?
The studies focus on follow-up assessments, but specific outcomes are not detailed in the provided evidence.
What complications have been reported?
Reported complications include general surgical risks, but specific adverse events are not detailed in the provided evidence.
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.