TraumaCad Neo (1.1)

by Brainlab  · Based in Germany → — End-to-end orthopedic templating software for streamlined surgical planning.
Orthopedics Radiology

Contact vendor
Regulatory Status Disclosed

Overview

TraumaCad Neo (1.1) by Brainlab is an advanced, FDA-cleared software solution designed to assist healthcare professionals in analyzing orthopedic conditions and planning surgical procedures. It has been reimagined for a streamlined, user-centric experience, leveraging trusted orthopedic workflows with enhanced image detection capabilities.

The software provides a comprehensive digital template library and a full suite of measurement tools for various orthopedic departments, including Total Hip Replacement (THR), Total Knee Replacement (TKR), Trauma, Pediatric, Deformity Correction, Foot & Ankle, Spine, and Upper Limb.

TraumaCad Neo supports DICOM and integrates seamlessly with Quentry, Brainlab’s proprietary web-based cloud service, enabling medical staff to upload images, plan expected results, and review post-operative images. It features unique calibration methods that automatically recognize devices like KingMark and VoyantMark, ensuring precise measurements. Time-saving automation, including image detection and automatic planning for hip and knee replacements, helps optimize clinical workflows.

The software is accessible via any web browser on PC, Mac, and iPad, offering flexibility for planning anywhere, anytime. Brainlab is committed to complying with HIPAA and GDPR regulations, ensuring secure handling and storage of patient data within its cloud services.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Extensive digital template library (regularly updated)
  • Comprehensive measurement tools (e.g., LLD, hip deformity, center of rotation, tibial slope)
  • Unique and automatic calibration methods (e.g., KingMark, VoyantMark)
  • Time-saving automation (e.g., image detection, Auto Total Hip & Knee Replacement planning)
  • Preoperative surgical planning and simulation
  • Postoperative image review
  • PACS integration
  • DICOM support
  • Seamless integration with Brainlab's Quentry cloud platform
  • Comprehensive surgical report generation

Use Cases

  • Total Hip Replacement (THR) planning
  • Total Knee Replacement (TKR) planning
  • Trauma surgery planning
  • Pediatric orthopedic planning
  • Spine surgery planning
  • Deformity correction planning

What Physicians Need to Know

DICOM Support & Standards
TraumaCad Neo (1.1) supports DICOM for importing and exporting radiological images, including X-ray, CT, and MR files. It also handles JPG images, as well as images from scanners or digital cameras. Brainlab provides DICOM Conformance Statements for its products.
PACS Integration Method
The software offers full PACS integration, allowing direct access to patient images from a PACS system. It can be integrated with existing PACS with enterprise-grade security and administrative management, or used as a standalone solution. Additionally, it integrates with Quentryu00ae, Brainlab's proprietary web-based cloud service, for image upload and planning.
Reading Room Workflow Impact
TraumaCad Neo is designed for a streamlined, user-centric experience, facilitating pre-operative planning and post-operative review for orthopedic procedures. It incorporates time-saving automation, such as automatic image detection and calibration, and auto total hip and knee replacement planning. The workflow guides users through image parameter definition, surgical procedure definition, measurements, templating, and report generation.
AI Model Architecture (deep learning approach)
The tool utilizes AI for automated features like image detection, calibration, and suggesting treatment parameters (e.g., anatomical region, total hip/knee replacement). Specific deep learning architectures (e.g., CNN details) are not explicitly detailed in publicly available information for TraumaCad Neo (1.1).
Processing Speed (per study)
Specific 'per study' processing speed data is not explicitly provided. The software emphasizes 'time-saving automation' and enabling 'quick and efficient' surgical planning.
FDA Clearance Pathway (510k/De Novo)
TraumaCad Neo (1.1) received 510(k) Premarket Notification clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device. Its predicate device is TraumaCad Mobile 2.0 (K160001).
Supported Modalities (CT/MRI/X-ray/US)
The software supports radiological images from CT, MRI, and X-ray modalities via DICOM. It is particularly highlighted for orthopedic planning, often utilizing X-ray images with specific calibration devices like KingMark for AP pelvic X-rays.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for the AI features of TraumaCad Neo (1.1) in orthopedic planning are not explicitly detailed in the provided public information.
RSNA/ACR Validation
No specific RSNA/ACR validation for TraumaCad Neo (1.1) is explicitly mentioned in the provided public information.
Physician Tip

Leverage TraumaCad Neo's automated features for initial image detection, calibration, and surgical parameter suggestions to expedite planning. Utilize the extensive digital template library for various orthopedic subspecialties. For accurate measurements, ensure proper use of calibration devices like KingMark. The software's ability to perform both pre-operative planning and post-operative review can enhance comprehensive patient management. Remember that clinical judgment and experience remain crucial, as the software assists rather than replaces primary radiological interpretation.

TraumaCad Neo (1.1) offers robust integration with existing PACS systems, allowing seamless image transfer and workflow. Its connection with Brainlab's Quentryu00ae cloud service facilitates image sharing and collaborative planning. The software also supports various image formats beyond DICOM, including JPG, for broader compatibility.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact vendor — Contact vendor for details; various licenses tailored to needs.
DeploymentCloud-based (accessed via web browser)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

TraumaCad Neo (1.1) is cleared by the U.S. Food and Drug Administration (FDA) as a Class II medical device under 510(k) number K243810. It is indicated for assisting healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying visual information, such as measurements and prosthesis templates, on relevant radiological images.

Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

TraumaCad Neo (1.1) is a cloud-based orthopedic templating software designed for comprehensive preoperative planning, measurements, and post-operative review. It offers a user-centric experience with a focus on streamlining workflows for orthopedic surgeons. The software includes an extensive digital template library and automated features like image detection for calibration and auto-planning for total hip and knee replacements.

Overall: Positive

Strengths

  • Cloud-based and accessible via web browser, offering an intuitive user experience.
  • Extensive digital template library with almost 4,000 implant families, continuously updated.
  • Time-saving automation features, including image detection for automatic calibration and auto-planning for THR and TKR.
  • Comprehensive measurement tools for various orthopedic procedures (THR, TKR, Trauma, Pediatric, Deformity Correction, Foot & Ankle, Spine, Upper Limb).
  • Seamless PACS integration for streamlined workflows.
  • Ability to generate detailed pre-surgical reports.

Limitations

  • No specific negative reviews or cons were found in the search results.
  • Direct pricing information is not readily available; users need to contact the vendor.
  • While innovative in automation, D2P is noted for a more cutting-edge approach in advanced surgical planning and visualization with deep learning and VR.
  • No user ratings were found on comparison sites like Vertex AI Search.

Based on reviews from: Physician AI Tools, SourceForge, Slashdot, Brainlab, YouTube

Last updated: 2026-07-18

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate TraumaCad Neo (1.1)

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

FDA
510(k) Premarket Notification - TraumaCad Neo (1.1)
The FDA granted 510(k) clearance to Brainlab's TraumaCad Neo (1.1) on June 4, 2025, classifying it as a Class 2 Radiological Image Processing System. This regulatory announcement details the device's intended use for pre-operative surgical planning and post-operative review of X-ray images, including automatic surgery outcome analysis for total hip arthroplasty.
2025-06
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing
This article from September 2025 discusses the challenges and best practices for ground truthing in AI/ML SaMD development, citing Brainlab's TraumaCad Neo (1.1) (K243810) as an example where the accuracy of implant presence and 2D landmark detection was tested against ground-truth annotations.
2025-09
Radiology AI Tools Directory
TraumaCad Neo (1.1) on Radiology AI Tools Directory
TraumaCad Neo (1.1) by Brainlab Ltd. is listed in the Radiology AI Tools Directory, indicating its FDA clearance on June 4, 2025, for image analysis/processing with CT/CTA modality.
2025-06
Brainlab
Brainlab - Physician Ai Tools
Brainlab's 'Physician Ai Tools' page mentions TraumaCad Neo (1.1) as part of their Radiology & Imaging AI offerings, highlighting its role in supporting medical professionals.
2026-04
RadAI Slice
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
This entry on RadAI Slice, updated in 2025, lists TraumaCad Neo (1.1) alongside other Brainlab Elements software, all of which received 510(k) clearance in 2025.
2025
Brainlab
Brainlab press releases, both past and present
While not specifically mentioning 'TraumaCad Neo (1.1)', Brainlab's press release archive shows a history of news related to TraumaCad, including a 2016 article about TraumaCad sales cementing Brainlab's market position and a 2015 release about TraumaCad Mobile receiving FDA clearance.
2026-05

Videos

Product demos, reviews, and walkthroughs for TraumaCad Neo (1.1).

Loading videos...

View all on YouTube

Frequently Asked Questions

TraumaCad Neo (1.1) incorporates automated features that can be considered AI-powered, such as automatic image detection for calibration and auto total hip and knee replacement planning. These functionalities streamline the pre-operative process by automatically aligning implants and calculating measurements, allowing surgeons to fine-tune the suggested plans.
TraumaCad Neo (1.1) is cleared by the U.S. Food and Drug Administration (FDA) as a Class II medical device and is CE marked as a Class Im medical device. Its web solution is also designed to be compliant with GDPR and HIPAA for patient data security and privacy.
While TraumaCad Neo (1.1) offers automated assistance, it is explicitly indicated for assisting healthcare professionals and requires clinical judgment and experience for proper use. The software is not intended for primary radiological image interpretation or appraisal, highlighting the need for physician oversight in all planning stages.
Alternatives to TraumaCad Neo (1.1) include solutions like OSSA 3D, which converts CT scans into virtual 3D printable models for surgical planning, and ARVIS, an augmented reality surgical guidance system. These alternatives also aim to enhance surgical planning through advanced digital tools and automation.
TraumaCad Neo (1.1) offers different licensing models tailored to user needs, including concurrent sessions for multi-user environments in medium to large healthcare facilities (on-premises) and single-user licenses for individual practitioners and small practices (cloud-based). Specific pricing details are generally obtained by requesting a proposal from Brainlab.
TraumaCad Neo (1.1) supports DICOM and integrates with Picture Archiving and Communication Systems (PACS) and Quentry, a proprietary web-based cloud service from Brainlab, for image management and sharing. The web solution is designed to be GDPR and HIPAA compliant, ensuring secure handling and transmission of patient information.

Related Tools

Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.
Oxipit ChestLink
Oxipit (part of Sectra group)
Clinical Decision Support & Reference
Oxipit ChestLink is the world's first CE Class IIb-certified autonomous AI application for healthy chest X-ray reporting, capable of identifying normal studies with 99.9% sensitivity. It automates the reporting of normal chest X-rays, reducing radiologist workload and improving efficiency.
Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CARPL.ai
CARPL.ai
Developer Tools & APIs
CARPL.ai is a vendor-neutral Artificial Intelligence (AI) platform that allows radiologists to access, assess, and integrate radiology AI solutions in their clinical practice. It provides a single user interface, a single data channel, and a single procurement channel for the testing, deployment, and monitoring of AI solutions in clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
SubtleHD-CT
Subtle Medical, Inc.
Radiology & Imaging AI
Subtle Medical's SubtleHD-CT is an AI software designed to enhance the quality and resolution of CT scans, reducing noise and improving image clarity. [7]

See all Radiology & Imaging AI tools →

More from Brainlab

(Elements) Cranial SRS w/ Cones
Brainlab
Neurology AI
Brainlab Elements Cranial SRS w/ Cones is an AI-powered software for precise stereotactic radiosurgery planning, offering automated workflows for cranial lesions and functional diseases.
(Elements) RT Planning Platform
Brainlab
Oncology AI
The Brainlab Elements RT Planning Platform is a comprehensive suite of software applications for streamlined and enhanced radiation therapy and radiosurgery treatment planning, offering advanced capabilities and automated workflows for various clinical indications. [9, 11, 12, 27]
Elements Segmentation [Cranial
Brainlab
Neurology AI
Brainlab Elements Segmentation [Cranial] is an AI-powered software for automated, patient-specific anatomical segmentation of cranial structures, including basal ganglia, for precision surgical and radiotherapy planning.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17

Investors who backed TraumaCad Neo (1.1)

Funded through the company that built this tool.

AI Tool Finder
AI-powered search. Results may not be comprehensive.