đź“Š Evidence-Based Reference
Additive Orthopaedics Patient Specific 3d Printed Bone Segments
Additive Orthopaedics
Summary: Additive Orthopaedics' patient-specific 3D printed bone segments are used for personalized orthopedic applications. Key evidence highlights their potential in improving surgical outcomes through customization.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180239 ↗
Decision Date ?
May 16, 2018
Product Code ?
HRS
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510(k) pathway on May 16, 2018. It is manufactured by Additive Orthopaedics and classified as a Class 2 medical device.
What It Is
The device consists of patient-specific 3D printed bone segments designed to match the unique anatomical features of individual patients. It is used in orthopedic surgeries to enhance fit and function, potentially improving surgical outcomes.
FDA-Cleared Indications
- Patient-specific orthopedic bone reconstruction based on the patient’s anatomy.
- Use in orthopedic surgery when a custom bone segment is needed to support anatomical fit and fixation.
Clinical Applications
- Patient-specific bone reconstruction during orthopedic surgery.
- Custom bone segment placement for reconstruction of a bone defect.
- Use during corrective orthopedic procedures when standard implants do not provide the required anatomical match.
- Custom bone segment use as part of orthopedic fixation or joint-related reconstruction when included in the surgical plan.
Evidence Summary
The literature includes 11 studies, comprising prospective cohort studies, RCTs, and reviews, published between 2022 and 2024. These studies explore the efficacy and safety of patient-specific 3D printed devices in various orthopedic applications.
Reported Outcomes
Published studies report that patient-specific 3D printed bone segments can improve surgical accuracy and patient satisfaction. They have been shown to enhance mechanical alignment in procedures like total knee arthroplasty and provide better fixation in osteotomies.
Safety Profile
Reported complications include potential issues with implant fit and alignment, which can lead to suboptimal outcomes. However, the studies generally indicate a favorable safety profile with no significant adverse events directly attributed to the device.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term outcomes and to compare the device's performance with conventional methods.
Practical Considerations
- The implant is designed from patient imaging and must be manufactured to the prescribed anatomy and surgical plan.
- Available dimensions and geometry are patient-specific rather than selected from a standard size range.
- Compatibility with fixation hardware, instruments, and other implants should be confirmed before surgery.
- The treating orthopedic surgeon should evaluate bone quality, infection risk, soft-tissue coverage, and whether a custom implant is appropriate.
- MRI safety and conditions depend on the implant’s materials and any associated fixation hardware; the device-specific labeling should be reviewed before MRI.
Frequently Asked Questions
What are the clinical indications for additive orthopaedics patient specific 3D printed bone segments?
The device is indicated for use in orthopedic surgeries requiring customized bone segments, such as joint replacements and corrective osteotomies.
What outcomes have been reported in clinical studies?
Studies have reported improved surgical accuracy, enhanced mechanical alignment, and increased patient satisfaction with the use of these devices.
What complications have been reported?
Safety data indicate potential issues with implant fit and alignment, but no significant adverse events have been directly linked to the device.
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.