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additive orthopaedics hammertoe correction system
Additive Orthopaedics
Summary: The Additive Orthopaedics Hammertoe Correction System is a medical device used to surgically correct hammertoe deformities. It is primarily used by orthopedic surgeons and podiatrists in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K160264 ↗
Decision Date
June 1, 2016
Product Code
HTY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on June 1, 2016. It is manufactured by Additive Orthopaedics and is classified as a Class 2 medical device under product code HTY.
What It Is
The Additive Orthopaedics Hammertoe Correction System is a surgical implant designed to correct hammertoe deformities. It typically involves a small implant that is inserted into the toe to straighten and stabilize the affected joint. The device leverages advanced materials and design to provide a durable and effective solution for toe alignment.
Clinical Applications
This device is commonly used in orthopedic and podiatric surgeries to treat patients with hammertoe, a condition where the toe is bent at the middle joint. It is often used in outpatient surgical centers or hospitals. The typical patient population includes adults with symptomatic hammertoe deformities that cause pain or difficulty in walking.
Indications for Use
The FDA-cleared indications for this device are for the surgical correction of hammertoe deformities. It is intended for patients who have not responded to conservative treatments and require surgical intervention to alleviate symptoms and improve toe alignment.
Practical Considerations
The device comes in various sizes to accommodate different toe anatomies. It is important for clinicians to select the appropriate size for optimal results. The surgical technique involves precise placement of the implant, requiring familiarity with foot anatomy and surgical skills.
Frequently Asked Questions
What is the Additive Orthopaedics Hammertoe Correction System used for?
It is used for the surgical correction of hammertoe deformities to straighten and stabilize the affected toe joint.
What specialties typically use this device?
Orthopedic surgeons and podiatrists typically use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for the surgical correction of hammertoe deformities in patients who require surgical intervention.
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.