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additive orthopaedics bunion system
Additive Orthopaedics
Summary: The Additive Orthopaedics Bunion System is a device used in the surgical correction of hallux valgus. It is primarily used to stabilize osteotomies during bunion surgery. Key evidence highlights its effectiveness in achieving stable fixation and improved patient outcomes.
FDA Clearance Information
Pathway
510K
Number
K163593 ↗
Decision Date
June 20, 2017
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Additive Orthopaedics Bunion System was cleared by the FDA through the 510(k) pathway on June 20, 2017. It is manufactured by Additive Orthopaedics and classified as a Class 2 device under product code HRS.
What It Is
The Additive Orthopaedics Bunion System is a surgical device designed to provide fixation during bunion correction procedures. It is used to stabilize osteotomies in the treatment of hallux valgus, ensuring proper alignment and promoting healing.
Clinical Applications
This device is commonly used in minimally invasive and open bunion surgeries to correct hallux valgus deformities. It is particularly useful in procedures requiring stable fixation of osteotomies to achieve optimal alignment and patient outcomes.
Evidence Summary
The available literature includes five studies, comprising retrospective analyses and randomized controlled trials, conducted between 2016 and 2025. These studies evaluate the device's efficacy in surgical outcomes and patient satisfaction.
Reported Outcomes
Published studies report that the Additive Orthopaedics Bunion System provides reliable fixation during bunion surgeries, with mean angular positions of screws indicating effective stabilization. Patient-reported outcomes suggest improved satisfaction and cosmesis post-surgery.
Safety Profile
Reported complications include issues related to hardware placement, particularly in the sagittal plane, which are critical for surgeons to consider during minimally invasive procedures. Overall, the device is associated with a favorable safety profile.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to compare the device's efficacy with alternative fixation methods.
Frequently Asked Questions
What are the clinical indications for Additive Orthopaedics Bunion System?
The device is indicated for use in the surgical correction of hallux valgus, providing fixation for osteotomies during bunion surgery.
What outcomes have been reported in clinical studies?
Studies have reported effective stabilization of osteotomies, improved angular alignment, and enhanced patient satisfaction post-surgery.
What complications have been reported?
Safety data indicate complications related to hardware placement, particularly in the sagittal plane, which require careful consideration during surgery.
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.