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additive orthopaedics patient specific 3d locking lattice plates
Additive Orthopaedics
Summary: The Additive Orthopaedics Patient Specific 3D Locking Lattice Plates are custom orthopedic implants designed for specific patient anatomy. They are primarily used in orthopedic surgeries for bone fixation. Key evidence highlights their biomechanical performance and customization benefits.
FDA Clearance Information
Pathway
510K
Number
K183011 ↗
Decision Date
January 10, 2019
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on January 10, 2019. It is manufactured by Additive Orthopaedics and classified as a Class 2 device under product code HRS.
What It Is
The device is a patient-specific orthopedic implant created using 3D printing technology. It is designed to match the unique anatomical structure of the patient, providing customized support and fixation in orthopedic surgeries.
Clinical Applications
These plates are commonly used in orthopedic procedures requiring bone fixation, such as fracture repair, corrective osteotomies, and joint stabilization. They offer tailored solutions for complex anatomical challenges.
Evidence Summary
The literature includes 11 studies, comprising various study types such as prospective cohorts and reviews, published between 2022 and 2024. These studies explore the efficacy, safety, and biomechanical performance of the device.
Reported Outcomes
Published studies report that the patient-specific 3D printed plates provide effective bone fixation and improved biomechanical performance compared to conventional designs. They also highlight the potential for enhanced surgical outcomes due to the customization of the implants.
Safety Profile
Reported complications include potential issues related to the fit and integration of the implant with the patient's anatomy. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively small sample sizes. Further research is needed to establish long-term outcomes and to compare the device's performance with traditional fixation methods.
Frequently Asked Questions
What are the clinical indications for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?
The device is indicated for use in orthopedic surgeries requiring customized bone fixation, such as fracture repair and corrective osteotomies.
What outcomes have been reported in clinical studies?
Studies report effective bone fixation and improved biomechanical performance, with potential for enhanced surgical outcomes due to customization.
What complications have been reported?
Reported complications include potential issues with implant fit and integration, though specific adverse events were not detailed.
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.