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enhatch orthopaedics patient technique-specific humeral
Enhatch Orthopaedics
Summary: The Enhatch Orthopaedics Patient Technique-Specific Humeral is a medical device used in orthopedic surgeries, specifically for the humerus. It is primarily utilized by orthopedic surgeons for patients requiring humeral repair or replacement.
FDA Clearance Information
Pathway
510K
Number
K112663 ↗
Decision Date
March 12, 2012
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 12, 2012. Manufactured by Enhatch Orthopaedics, it is classified as a Class 2 device under product code HRS.
What It Is
This device is a specialized orthopedic implant designed for procedures involving the humerus, the long bone in the upper arm. It is used to support or replace parts of the humerus during surgical interventions. The device is tailored to fit specific patient anatomy, enhancing surgical outcomes by providing a more precise fit and potentially reducing recovery time.
Clinical Applications
The Enhatch Orthopaedics Humeral device is commonly used in orthopedic surgeries such as fracture repair, joint replacement, or reconstructive procedures involving the humerus. It is typically employed in hospital settings or specialized orthopedic centers. The device is suitable for adult patients who have sustained humeral fractures or require joint replacement due to conditions like arthritis.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients needing surgical intervention on the humerus, such as those with fractures or degenerative joint conditions. It is designed to assist in the repair or replacement of the humeral bone.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is important for surgeons to select the appropriate size and ensure compatibility with other surgical instruments. Proper technique is crucial to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is the Enhatch Orthopaedics Humeral used for?
It is used for surgical procedures involving the humerus, such as fracture repair or joint replacement.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for patients needing humeral repair or replacement, often due to fractures 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.