MyShoulder Planner (5.3SSWPL)

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

Contact for pricing
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.
AI Model Architecture (deep learning approach)
The software uses machine learning algorithms for automatic segmentation of a 3D model of the patient's anatomy.
FDA Clearance Pathway
510(k) Number: K241292.
Supported Modalities
CT scans are the supported modality for image processing.
Physician Tip

MyShoulder Planner is a preoperative planning tool for total shoulder replacement surgery. It is designed to assist in planning the humeral and glenoid components using Medacta Shoulder System prostheses. The software should not be used for diagnostic purposes. It processes CT scan images to visualize, measure, and reconstruct anatomic data, aiding in decisions on implant size and positioning. The software can generate patient-specific planning reports and allows for requesting MyShoulder patient-matched guides based on the pre-surgical plan.

The MyShoulder Planner software is designed to work with CT scan images in DICOM format.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentOn-premise / Hybrid
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Orthopedics

What the Web Says

Medacta's MyShoulder Planner (5.3SSWPL) is an AI-powered software designed for personalized 3D preoperative planning of total shoulder replacement surgery. It processes CT scan images to help surgeons visualize, measure, and reconstruct anatomical data, aiding in decisions regarding implant size and positioning. The software also generates patient-specific planning reports and can be used to request patient-matched guides.

Overall: Positive

Strengths

  • AI-powered for personalized 3D preoperative planning
  • Utilizes CT scans to optimize implant positioning
  • Generates patient-specific planning reports
  • Allows visualization, measurement, and reconstruction of anatomic data
  • Supports planning of both humeral and glenoid components in total shoulder replacement
  • Can be used to request patient-matched guides

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: fda.gov, physicianaitools.com

Last updated: 2026-10-31

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Videos

Product demos, reviews, and walkthroughs for MyShoulder Planner (5.3SSWPL).

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Frequently Asked Questions

MyShoulder Planner (5.3SSWPL) is an AI-powered software that uses machine learning algorithms to process CT scans. It creates personalized 3D preoperative plans for total shoulder replacement surgery, helping surgeons optimize implant positioning and generate patient-specific guides.
MyShoulder Planner (5.3SSWPL) is a medical device that received FDA approval on January 30, 2025, under a 510(k) premarket notification. It is intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals.
While the software has undergone verification and validation activities for segmentation performance, showing adequate accuracy compared to manual segmentation, no clinical studies have been conducted. Other reported limitations for Medacta products in general include potential issues with training, communication, and management expectations.
Medacta International also offers the NextAR Augmented Reality Surgical Platform, which includes applications for shoulder procedures, leveraging AI and machine learning for personalized pre-operative planning and real-time surgical guidance. Other specific alternatives are not detailed in the provided information.
The pricing for MyShoulder Planner (5.3SSWPL) is not publicly available and requires direct contact with Medacta International for details.

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