This data sheet is for surgeons and clinical teams preparing cranioplasty cases. It lists the scan and anatomy requirements, supported cases, platform outputs and the case charges policy.
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 | If present, upload your own segmentation as STL |
Platform Outputs
After approval, the case outputs include:
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, with guides | ✅ 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.