Case Criteria
Anatomical Requirements
To ensure a successful case for planning and guide creation, the following anatomical requirements must be met:
Scapula Requirements
Full visibility of the glenoid cavity.
Clear visualization of the posterior aspect (trianum).
At least 50% of the inferior length of the scapula must be included.
Humerus Requirements
A full humeral head must be present.
At least one-third of the overall humeral length must be included.
**If only one of the bones (scapula or humerus) is available, the Customed system will support planning and guide generation for that part only. If both bones are present, a full surgical plan is supported.
Supported Case Types & Region
Left or Right Shoulder
Total Shoulder Arthroplasty (Anatomical)
Reverse Shoulder Arthroplasty
Hemiarthroplasty
Unsupported Case Types
Cases involving non-shoulder joints (e.g., spine, elbow).
CT scans with severe metal artifacts that obscure bone structures and cannot be segmented.
Revision surgeries with large, existing implants that obscure glenoid or humeral landmarks.
Partial datasets missing the required anatomical landmarks listed above.
STL Segmentation Guidelines
Optional upload of .STL segmentation is accepted under the following conditions:
.STL includes a complete glenoid or humeral head (or both).
Scapula meets the anatomical visibility requirements above.
Humerus must include a full head and at least one-third of its length.
STL files should not show pre-implanted components or artifacts unless for review only.
CT Imaging Requirements
Parameter | Requirement |
Slice Thickness | ≤ 1.5 mm |
Spacing Between Slices | ≤ 1.5 mm |
Pixel Spacing | ≤ 1.0 mm |
Motion Artifact | Minimize; patient must remain still |
Metal Artifact | Use manual segmentation if presented (upload in .STL) |
Platform Outputs
Upon approval, the Customed platform will generate:
Anatomical Model Files:
Cropped region focused on implant site (.STL)Full anatomy model (.STL)
Guide Files:
Glenoid guide (.STL) if scapula is included
Humerus guide (.STL) if humerus is included
Case Report Document:
.PDF file summarizing surgical planning, measurements, and device design
Case Charges Policy
Condition | Charge Applied |
Case rejected by CustoMED (technical/incomplete) | ❌ No Charge |
Case cancelled or rejected by user prior to approval | ❌ No Charge |
Case submitted for validation or training purposes | ❌ No Charge |
Case fully approved and guides generated | ✅ Charged |
Compatibility Statement
This module is not a replacement for clinical decision-making. CustoMED software does not provide therapeutic recommendations. All final planning decisions - including implant design, positioning, and surgical execution - must be made and reviewed by a licensed healthcare professional. A healthcare professional must always rely on their own professional clinical judgment when deciding whether to use any product in the treatment of a specific patient.