Case Criteria
Anatomical Requirements
Ensure the CT or STL scan includes the complete defect zone, the zygoma, and extends to the nasal region.
Clearly visible, clean-edged cranial defect
Supported Case Types & Region
Unilateral & Bilateral cases
Containing design with flange, temporal cut, holes and fixation drills
Defects > 30 mm in diameter
Defects within the highlighted (in blue) region, see image below
Unsupported Case Types
Revision surgeries with a visible existing implant in the CT scan or STL
Defects involving the zygoma, orbital bones, or facial skeleton
Very small defects < 30 mm in diameter
STL Segmentation Guidelines
Optional upload of .STL segmentation is accepted under the following conditions:
Defect area is fully represented
A defect is clearly included with clean-edges
The file does not depict an already repaired or reconstructed skull
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:
Implant file (molds if applicable) file in .STL format (x2 for Bilateral)
Molds file (if applicable) in .STL format (x2 for Bilateral)
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.