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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 ?
510(k)
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.
FDA-Cleared Indications
- Fixation of osteotomies performed during surgical correction of hallux valgus.
- Stabilization and maintenance of bone alignment during bunion correction procedures.
Clinical Applications
- Fixation of first metatarsal osteotomies during hallux valgus correction.
- Stabilization of bunion osteotomies during open surgical procedures.
- Stabilization of bunion osteotomies during minimally invasive or percutaneous procedures when the system is used according to its labeling.
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.
Practical Considerations
- The system must be selected in a size and configuration appropriate for the patient's anatomy and the planned osteotomy.
- Use requires proper surgical exposure or access, bone preparation, implant placement and fixation according to the manufacturer's instructions.
- The surgeon should confirm compatibility among the implants, instruments and planned surgical technique before the procedure.
- MRI safety and conditions should be confirmed from the device's current labeling; do not assume the system is safe for every MRI setting.
- Contraindications and precautions include infection, inadequate bone quality or quantity, and medical conditions that may impair healing, as specified in the labeling and surgical assessment.
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.