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ascension humeral resurfacing arthoplasty hra system tps ha
Ascension Orthopedics
Summary: The Ascension Humeral Resurfacing Arthroplasty HRA System TPS HA is a medical device used in shoulder joint reconstruction. It is primarily used by orthopedic surgeons to treat patients with shoulder arthritis or other degenerative conditions.
FDA Clearance Information
Pathway
510K
Number
K071064 ↗
Decision Date
June 22, 2007
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Ascension Humeral Resurfacing Arthroplasty HRA System TPS HA was cleared through the FDA 510(k) pathway on June 22, 2007. 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 HRA System TPS HA is a prosthetic device designed for shoulder joint resurfacing. It replaces the damaged surface of the humeral head with a metal cap, preserving more of the patient's natural bone compared to traditional shoulder replacements. This device is particularly useful for patients with arthritis or other degenerative joint diseases, providing pain relief and improved joint function.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in shoulder arthroplasty procedures. It is suitable for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the shoulder. The device is typically used in hospital operating rooms or specialized orthopedic surgical centers and is most often utilized by orthopedic surgeons specializing in shoulder and upper extremity procedures.
Indications for Use
The FDA-cleared indications for this device include treatment of shoulder joint conditions such as arthritis where the humeral head is damaged. It is intended for patients who require joint resurfacing to alleviate pain and restore function.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. It is important to ensure proper sizing and alignment during surgery to optimize outcomes. Compatibility with existing surgical instruments and techniques should be verified prior to use.
Frequently Asked Questions
What is Ascension Humeral Resurfacing Arthroplasty HRA System TPS HA used for?
It is used for shoulder joint resurfacing in patients with arthritis or degenerative joint conditions.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in shoulder and upper extremity procedures, typically use this device.
What are the FDA-cleared indications?
The device is indicated for shoulder joint resurfacing in patients with conditions like arthritis where the humeral head is damaged.
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.