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additive orthopaedics bone wedge system
Additive Orthopaedics
Summary: The Additive Orthopaedics Bone Wedge System is a medical device used primarily for bone reconstruction. It has been FDA-cleared and is supported by multiple studies evaluating its clinical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K153207 ↗
Decision Date
September 7, 2016
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Additive Orthopaedics Bone Wedge System was cleared by the FDA through the 510(k) pathway on September 7, 2016. It is manufactured by Additive Orthopaedics and classified as a Class 2 device under product code HRS.
What It Is
The Additive Orthopaedics Bone Wedge System is designed for bone reconstruction procedures. It functions by providing structural support and stability to bone segments, facilitating proper alignment and healing.
Clinical Applications
This device is commonly used in orthopedic surgeries requiring bone reconstruction, such as osteotomies. It is particularly useful in procedures where precise bone alignment and stabilization are critical.
Evidence Summary
The available literature includes a variety of study types, such as systematic reviews and case series, with a total of 10 studies. These studies span from 2022 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Additive Orthopaedics Bone Wedge System is effective in achieving desired bone alignment and stability. Outcomes include improved survivorship and functional results in orthopedic procedures. The device has shown positive results in terms of biomechanical stability and patient-reported outcomes.
Safety Profile
Reported complications include issues related to central sensitization, which may affect patient-reported outcomes and osteotomy site pain. No significant device-related adverse events have been highlighted in the available studies.
Evidence Limitations
The evidence base is limited by the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the Additive Orthopaedics Bone Wedge System?
The device is indicated for use in bone reconstruction procedures, particularly in orthopedic surgeries requiring precise alignment and stabilization.
What outcomes have been reported in clinical studies?
Studies have reported improved bone alignment, stability, and patient-reported outcomes, with positive results in terms of biomechanical stability.
What complications have been reported?
Safety data indicate that complications may include central sensitization affecting outcomes, but no significant device-related adverse events have been reported.
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.