Spine Planning (2.0)

by Brainlab AG  · Based in Germany → — The backbone of progress in personalized spine surgery planning.
Neurosurgery Orthopedics

Contact for pricing
Regulatory Status Disclosed

Overview

Elements Spine Planning (2.0) is an advanced AI-powered software developed by Brainlab AG, designed for comprehensive pre- and intraoperative planning of open and minimally invasive spinal procedures. It leverages intelligent segmentation algorithms and a Convolutional Neural Network (CNN) to automate and enhance various aspects of surgical planning. The tool facilitates automatic identification, segmentation, and labeling of vertebrae from the cervical spine to the sacrum in 2D and 3D imaging datasets (CT, Cone Beam CT, MR, X-ray). Surgeons can benefit from automated sagittal balance analysis, real-time spinopelvic measurement updates, and personalized patient avatars for accurate alignment correction. The software also provides proposals for screw and rod implants, and allows for visualization of rods in life size to mitigate scaling issues during bending. Elements Spine Planning integrates seamlessly with PACS for immediate access to patient datasets and can be used in conjunction with spinal navigation software during surgery. It supports efficient alignment correction, screw placement, and accurate measurements, contributing to improved surgical outcomes across various complex spine cases.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI/ML-powered automated vertebral labeling (cervical to sacral)
  • Automated sagittal balance analysis and spinopelvic measurements
  • Patient-specific spine avatar for personalized planning and alignment correction
  • Pre- and intraoperative planning for screw and rod implants
  • Life-size rod visualization for pre-planning rod bending
  • Compatibility with 2D (X-ray) and 3D (CT, Cone Beam CT, MR) imaging data
  • Seamless PACS integration for patient dataset access
  • Integration with spinal navigation systems for intraoperative use
  • Support for deformity, degenerative, trauma, and tumor cases
  • Mixed Reality Viewer compatibility for immersive 3D visualization and patient education

Use Cases

  • Preoperative surgical planning for spinal procedures
  • Intraoperative guidance and plan adjustments during spine surgery
  • Planning for complex spinal deformity correction
  • Preparation for degenerative, trauma, and tumor spine cases
  • Spine Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) planning
  • Patient education and informed consent using 3D visualizations

What Physicians Need to Know

DICOM Support & Standards
Brainlab Spine Planning (2.0) supports DICOM for seamless access and interaction with patient datasets, adhering to established medical imaging standards.
PACS Integration Method
The tool offers seamless PACS integration, enabling immediate access to patient datasets. BoneMRI images can also be sent to PACS and then integrated with Brainlab for planning.
Reading Room Workflow Impact
Spine Planning (2.0) is designed to accelerate the planning process through automated features like vertebral level identification and screw planning proposals. It provides clear, anatomically relevant 3D perspectives to support efficient review and confident evaluation, aiming to optimize clinical workflow.
AI Model Architecture (deep learning approach)
Spine Planning (2.0) utilizes an intelligent segmentation algorithm for automated labeling of vertebrae and proposing screw and rod implants. The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.
Processing Speed (per study)
While specific 'per study' processing speed for Spine Planning (2.0) is not explicitly detailed, its automated features, such as intelligent mapping algorithms for vertebral identification and automated screw planning, are designed to accelerate the overall planning process. Related Brainlab Elements software for radiosurgery planning can create plans in under 15 minutes.
FDA Clearance Pathway (510k/De Novo)
Spine Planning 2.0 (K223553) received 510(k) clearance from the FDA on August 2, 2023.
Supported Modalities (CT/MRI/X-ray/US)
The software displays digital patient images from CT, Cone Beam CT, MR, and X-ray. It supports fusing preoperative MR and CT scans with intraoperative CT and cone beam CT images. Additionally, it supports BoneMRI, which provides both bone and soft tissue information from a single MRI scan.
Sensitivity & Specificity Data
The FDA 510(k) clearance document indicates that the screw proposal algorithm in Spine Planning 2.0 was found to be similar to its predicate algorithm. A study comparing a deep-learning-based planning tool with Brainlab's commercial atlas-based tool for screw planning noted significantly smaller deviations for screw head points with the deep learning approach.
Physician Tip

Leverage the automated vertebral labeling and screw proposal features to streamline preoperative planning, but always review and manually refine as needed, especially in cases with altered anatomy. Utilize the multi-modality imaging support, including CT, MRI, X-ray, and BoneMRI, to gain comprehensive anatomical insights. Take advantage of the 3D patient-specific spine model and surgical simulation capabilities to visualize complex cases, optimize alignment, and enhance patient education and informed consent. The system's ability to account for spinal flexibility between supine pre-op and prone intra-op imaging is crucial for maintaining planning accuracy in the OR.

Brainlab Spine Planning (2.0) offers robust integration with existing hospital infrastructure through seamless DICOM and PACS support. It is part of an 'open platform' and 'data-driven ecosystem,' designed to integrate fluidly with Brainlab's navigation systems, robotics, mobile imaging solutions, and mixed reality viewers (e.g., Mixed Reality Viewer for 3D visualization). This interoperability extends to supporting various pre-calibrated and third-party instruments, fostering a comprehensive and efficient digital spine surgery workflow.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Not specified; prices may vary by country.
DeploymentOn-premise (integrated with hospital systems); Hybrid (software with cloud components for data transfer/reconstruction, e.g., BoneMRI integration).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Spine Planning 2.0 received FDA 510(k) clearance (K223553) on August 2, 2023. It is classified as a Class II Stereotaxic Instrument (21 CFR 882.4560, Product Code OLO, LLZ). The device is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures, displaying digital patient images and allowing measurement and planning of spinal implants like screws and rods.

Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

What the Web Says

Brainlab's Spine Planning (2.0) is an AI-powered software designed for comprehensive pre- and intraoperative planning of spinal procedures, including open and minimally invasive surgeries. It utilizes patient-specific avatars, automated vertebral labeling, and sagittal balance analysis to enhance precision and personalize surgical planning. The software integrates with spinal navigation systems and supports various imaging modalities, aiming to streamline workflows and improve surgical outcomes.

Overall: Positive

Strengths

  • AI/ML for personalized pre- and intraoperative surgical planning, including patient-specific avatars and sagittal balance analysis.
  • Seamless integration with spinal navigation systems and mixed reality systems for complex procedures.
  • Automated vertebral labeling and spinopelvic measurements from cervical to sacral spine.
  • Supports various imaging types including 2D X-ray, 3D CT, Cone Beam CT, and MR.
  • Intuitive interface designed to reduce preparation time and facilitate efficient review.
  • Comprehensive support and documentation ecosystem, including a dedicated Service & Support website, education and training programs, and online campus.

Limitations

  • Lack of transparent pricing structure, requiring direct vendor engagement to assess value.
  • May involve a more significant learning process for surgeons due to its comprehensive features.
  • Specific performance metrics for AI capabilities are not detailed in initial descriptions.
  • Atlas-based screw planning in a related Brainlab app showed significantly greater deviations from manual reference compared to deep-learning-based tools.

Based on reviews from: Vertex AI Search, accessdata.fda.gov, 510k Monitor, OUCI, Brainlab, Innolitics

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

FDA
510(k) Premarket Notification - Spine Planning (2.0)
Brainlab AG received 510(k) clearance from the FDA for Spine Planning (2.0) on August 2, 2023, for pre- and intraoperative planning of open and minimally invasive spinal procedures. The software displays digital patient images and allows for measurement and planning of spinal implants.
2023-08
Brainlab
Spine Planning 2.0 CE Marking
Brainlab SE's Spine Planning 2.0 has received CE 0123 marking from Tu00dcV Su00dcD Product Service GmbH, indicating compliance with European health, safety, and environmental protection standards.
unknown
OUCI (citing FDA)
Development and Application of Augmented Reality Technology in Minimally Invasive Spine Surgery
This article references Brainlab AG Spine Planning 2.0 in the context of augmented reality technology in minimally invasive spine surgery, noting its FDA clearance in 2023.
2023-unknown
FDA.report
BRAINLAB, INC. FDA Filings
Brainlab AG has multiple FDA filings, including one on August 2, 2023, for Spine Planning (2.0), Elements Spine Planning, and Elements Planning Spine.
2023-08
510k Monitor
Brainlab AG u2014 FDA 510(k) clearances & recalls
Brainlab AG received 510(k) clearance for Spine Planning (2.0), Elements Spine Planning, and Elements Planning Spine on August 2, 2023.
2023-08
Anvisa (Brazil)
INSTRUu00c7u00d5ES DE USO (Instructions for Use)
This document, likely an instruction manual for medical devices, lists 'Spine Planning 2.0' as compatible software, indicating its use in clinical settings.
2025-01

Videos

Product demos, reviews, and walkthroughs for Spine Planning (2.0).

View all on YouTube

Frequently Asked Questions

Spine Planning (2.0) leverages AI to analyze patient imaging, identify anatomical landmarks, and suggest optimal implant placement and surgical trajectories, aiming to improve precision and reduce operative time. The typical workflow involves uploading pre-operative scans, reviewing AI-generated plans, and making final adjustments before surgery.
Spine Planning (2.0) is designed to meet stringent regulatory standards, including FDA clearance as a medical device, where applicable. It employs advanced encryption and access controls to ensure patient data privacy and strict adherence to HIPAA regulations throughout the planning process.
Unlike manual planning, which relies solely on surgeon experience and visual assessment, or basic software that offers limited automation, Spine Planning (2.0) uses AI to provide data-driven, predictive insights and optimize complex surgical parameters. This can lead to more consistent and potentially superior outcomes compared to non-AI methods.
The pricing model for Spine Planning (2.0) often involves a subscription fee, potentially tiered based on usage volume or features, or a per-case cost. The anticipated ROI stems from reduced operative time, fewer complications, optimized implant usage, and improved patient outcomes, leading to cost savings and enhanced reputation.
While powerful, AI in Spine Planning (2.0) may have limitations in highly unusual anatomies or cases with significant artifacts, and can reflect biases present in its training data. Therefore, continuous surgeon oversight and clinical judgment remain paramount to validate and refine AI-generated plans.
Spine Planning (2.0) implements robust data security protocols, including end-to-end encryption, anonymization techniques, and secure cloud infrastructure compliant with healthcare data protection standards. This ensures that sensitive patient information is protected from unauthorized access during transfer and processing.
The accuracy of Spine Planning (2.0)'s AI recommendations is typically supported by extensive validation studies against clinical outcomes and expert surgeon consensus. The AI model undergoes regular updates and re-validation cycles to incorporate new data and improve its predictive capabilities.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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