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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 ?
510(k)
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.
FDA-Cleared Indications
- Surgical correction of hammertoe deformities.
Clinical Applications
- Implantation during surgical correction of a hammertoe deformity.
- Stabilization of the affected toe after correction of its abnormal alignment.
- Use in foot surgery for patients with symptomatic hammertoe requiring operative treatment.
Practical Considerations
- The system is available in different sizes; the surgeon selects the implant based on the patient’s toe anatomy and the planned surgical technique.
- Placement requires knowledge of toe and forefoot anatomy and is performed by a qualified orthopedic or podiatric surgeon.
- The FDA record summarized here does not provide specific MRI-safety information. MRI compatibility should be confirmed in the device’s current labeling before imaging.
- Potential contraindications, implant-selection requirements, sterilization instructions, and compatibility with other implants should be reviewed in the manufacturer’s current surgical technique and labeling.
- The implant is intended for surgical use and should not be used as a substitute for nonoperative treatment when surgery is not clinically indicated.
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.