MyShoulder Planner (5.3SSWPL)

by Medacta International  · Based in Switzerland → — Personalized 3D Preoperative Planning for Total Shoulder Replacement.
Orthopedics
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Regulatory Status Disclosed

Overview

The MyShoulder Planner (5.3SSWPL) is an advanced software solution developed by Medacta International for patient-specific preoperative planning in total shoulder replacement surgery. It leverages CT scan images in DICOM format to create detailed 3D models of the patient’s anatomy. Utilizing machine learning algorithms for automatic segmentation (or manual by a Medacta engineer), the software enables surgeons to visualize and precisely plan the placement of humeral and glenoid components, assessing the biomechanical effects of different device choices and positioning options. The MyShoulder Planner is designed to support the use of Medacta Shoulder System prostheses and facilitates the generation of patient-specific planning reports and the request for patient-matched guides, aiming to enhance the accuracy and efficiency of shoulder replacement procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Patient-specific preoperative planning
  • CT scan image processing (DICOM format)
  • 3D anatomical model segmentation (AI/machine learning or manual)
  • Visualization of device choices and positioning options
  • Planning of humeral and glenoid components
  • Support for Medacta Shoulder System prosthesis
  • Generation of patient-specific planning reports
  • Ability to request patient-matched guides
  • Annotation of anatomical structures
  • Enhanced accuracy and efficiency in procedures

Use Cases

  • Preoperative planning for total shoulder replacement surgery
  • Visualization and optimization of implant size and positioning
  • Designing personalized surgical strategies
  • Improving surgical accuracy and reproducibility
  • Facilitating patient-matched guide creation
  • Education and surgical rehearsal

What Physicians Need to Know

DICOM Support & Standards
The MyShoulder Planner software processes CT scan images in DICOM format.
PACS Integration Method
The MyShoulder Planner workflow involves Medacta receiving CT images, with planning submitted to the surgeon for approval through an interactive website (WebPlanner). Cases are managed entirely online, eliminating the need for software installation by the user.
Reading Room Workflow Impact
This tool is intended for surgeons as a preoperative planning tool for total shoulder replacement surgery, not for diagnostic purposes in the radiology reading room. It enables surgeons to visualize, measure, reconstruct anatomic data, and make decisions on implant size and positioning, leading to patient-specific planning reports and guides.
AI Model Architecture (deep learning approach)
The software utilizes machine learning algorithms for the automatic segmentation of a 3D model of the patient's anatomy.
FDA Clearance Pathway (510k/De Novo)
The MyShoulder Planner software has received FDA 510(k) clearance.
Supported Modalities (CT/MRI/X-ray/US)
The software specifically processes CT scan images for 3D reconstruction and planning.
Physician Tip

MyShoulder Planner is a valuable preoperative tool for total shoulder replacement, aiding in precise implant selection and positioning based on patient-specific anatomy. Surgeons should actively engage with the interactive web-based planning platform to review and validate the proposed surgical plan, ensuring it aligns with their preferences and clinical judgment. The system's output includes patient-specific guides, which can contribute to accurate intraoperative execution and potentially reduce operating time.

The primary input for MyShoulder Planner is DICOM-formatted CT scan images. The planning process is facilitated by Medacta engineers and accessed by surgeons via an online WebPlanner, indicating a web-based interaction rather than direct local PACS integration. The output includes patient-specific planning reports and files for patient-matched guides.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Contact Medacta International for detailed pricing information.
DeploymentOn-premise / Hybrid
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The MyShoulder Planner (5.3SSWPL) received FDA 510(k) clearance (K241292) on January 30, 2025. It is intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals, specifically for planning humeral and glenoid components using Medacta Shoulder System prosthesis.
Integrations
EHR Not specified
Specialties Orthopedics

What the Web Says

MyShoulder Planner (5.3SSWPL) is a specialized AI-powered software designed for preoperative planning of total shoulder replacement surgery, specifically integrated with Medacta's implant system. It allows surgeons to create patient-specific plans based on CT scans, visualize the effects of different device choices, and optimize implant positioning. The software also facilitates the generation of patient-specific planning reports and the ordering of patient-matched guides.

Overall: Mixed

Strengths

  • Highly specialized for total shoulder replacement surgery planning.
  • AI-powered for automated 3D model segmentation.
  • Optimizes implant positioning.
  • Generates patient-specific planning reports.
  • Enables ordering of patient-matched guides.
  • Integrated with Medacta's implant system.

Limitations

  • Highly specialized, limiting its utility to a specific niche compared to general-purpose 3D medical modeling software.
  • No ratings or reviews available on common platforms like G2 or Capterra.
  • Pricing information is not publicly available.
  • Does not allow guide design inside the software; guides are ordered as designed by Medacta.

Based on reviews from: Physician Ai Tools, FDA.gov, Innolitics

Last updated: 2026-07-19

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Press & Coverage

RadAI Slice
MyShoulder Planner (5.3SSWPL) | FDA Radiology AI Device - X-ray Interpreter
Medacta International S.A.'s MyShoulder Planner (5.3SSWPL) received FDA approval on January 30, 2025. This software uses machine learning to create 3D models from CT scans for pre-operative planning of total shoulder replacement surgeries, aiding in implant sizing and positioning.
2025-01
FDA
Medacta International S.A. January 30, 2025 Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research
This FDA 510(k) premarket notification details the approval of Medacta's MyShoulder Planner (5.3SSWPL) as a Class II medical device for pre-operative planning in total shoulder replacement surgery. It outlines the device's intended use, technology, and regulatory classification.
2025-01
FDA
K241292 - 510(k) Premarket Notification - FDA
The FDA's official 510(k) premarket notification page provides details for MyShoulder Planner (5.3SSWPL), including applicant information, regulation number, product code, and a summary of the device's classification and review.
2026-06
RadAI Slice
Medacta International | Radiology AI Companies - X-ray Interpreter
Medacta International is listed among radiology AI companies, with MyShoulder Planner (5.3SSWPL) highlighted as a software tool for surgeons to plan total shoulder replacement surgeries by processing CT scans.
unknown

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Frequently Asked Questions

MyShoulder Planner (5.3SSWPL) is a software tool designed for surgeons to plan total shoulder replacement surgeries, processing CT scans to create 3D models of the patient's shoulder anatomy. It integrates by allowing surgeons to visualize, measure, and reconstruct anatomic data to decide implant size and positioning. While specific training requirements aren't detailed, its design as a pre-operative planning tool suggests a learning curve focused on its interface and AI-driven recommendations.
MyShoulder Planner (5.3SSWPL) received FDA approval on January 30, 2025, as a Class II medical device for preoperative planning of total shoulder replacement surgery. It is intended for use with Medacta Shoulder System prostheses. While the FDA documentation confirms its regulatory status, specific details on patient data privacy and HIPAA compliance protocols are not explicitly detailed in the provided snippets, but as a medical device, it would be expected to adhere to these standards.
MyShoulder Planner (5.3SSWPL) is a pre-operative planning tool that uses machine learning algorithms for automatic segmentation of 3D shoulder anatomy models. It is considered substantially equivalent to the Blueprint Patient Specific Instrumentation (K203315) with respect to design concept, workflow, input images, user interface, segmentation, and measurement output. A key differentiator is that MyShoulder Planner enables patient-matched guides to be ordered as designed by Medacta, rather than allowing guide design within the software itself.
The provided information does not detail the specific pricing model for MyShoulder Planner (5.3SSWPL). However, as a specialized medical device software, pricing models typically involve licensing fees or per-use charges. The potential return on investment would likely stem from improved surgical precision, potentially leading to better patient outcomes and reduced revision rates, though a detailed financial analysis would be required.
MyShoulder Planner (5.3SSWPL) utilizes machine learning algorithms for 3D model segmentation, and verification and validation activities showed adequate accuracy compared to manual segmentation. The software's performance is based on processing CT scan images in DICOM format. While no clinical studies were conducted, the accuracy of AI algorithms can generally be influenced by the quality of input imaging and the diversity of training data, potentially impacting complex cases or rare anatomies.
MyShoulder Planner (5.3SSWPL) is intended for use by surgeons as a preoperative planning tool, indicating that it functions as a decision support system rather than an autonomous one. Surgeons are able to visualize, measure, and reconstruct anatomic data, enabling them to make decisions on implant size and positioning. This implies that human oversight is crucial, and surgeons retain the ability to review and finalize all planning decisions.
The provided FDA documentation for MyShoulder Planner (5.3SSWPL) does not specifically detail the data security protocols for transmission and storage, nor its integration with cloud-based services. However, as a regulated medical device, it would be subject to stringent requirements for protecting patient health information, including adherence to cybersecurity best practices and relevant data protection regulations.
The available information does not specify the exact process for software updates, bug fixes, or ongoing technical support for MyShoulder Planner (5.3SSWPL). However, as a medical device, manufacturers are required to review and approve changes to device design and production, and document these changes. This suggests a structured process for maintaining and supporting the software post-market.

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