Case Criteria
Anatomical Requirements
To ensure a successful case for planning and guide creation, the following anatomical requirements must be met:
Femur Requirements
Full visibility of the distal femur, including medial and lateral condyles.
Clear visualization of the femoral trochlea.
Inclusion of sufficient femoral shaft length to allow accurate axis definition (recommended ≥ 8–10 cm proximal to the joint line).
Tibia Requirements
Full visibility of the proximal tibial plateau, including medial and lateral plateaus.
Clear visualization of the intercondylar eminence.
Inclusion of sufficient tibial shaft length to allow mechanical and anatomical axis calculation (recommended ≥ 8–10 cm distal to the joint line).
If only one of the bones (femur or tibia) is available, the CustoMED system will support planning and guide generation for that bone only. If both bones are present, a full total knee surgical plan is supported.
Supported Case Types & Region
Left or Right Knee
Total Knee Replacement (Primary TKR)
Mechanical or kinematic alignment workflows (where supported by the indication configuration)
Unsupported Case Types
Cases involving non-knee joints (e.g., hip, shoulder, spine).
CT scans with severe motion or metal artifacts that obscure femoral or tibial landmarks and prevent reliable segmentation.
Complex revision surgeries with large existing implants, stems, or augments that obscure native anatomy.
Partial datasets missing critical anatomical landmarks listed above (e.g., incomplete femoral condyles or tibial plateau).
STL Segmentation Guidelines
Optional upload of .STL segmentation is accepted under the following conditions:
.STL includes a complete distal femur and/or complete proximal tibia.
Femur STL includes both condyles and sufficient shaft length for axis definition.
Tibia STL includes the full plateau and sufficient shaft length.
STL files should not include pre-implanted components or fixation hardware, unless explicitly uploaded for reference only.
Femur and tibia should be provided as separate STL files when both are included.
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 the knee joint (.STL)
Full femur and/or tibia anatomy model (.STL)
Guide Files
Femoral cutting / positioning guide (.STL) if femur is included
Tibial cutting / positioning guide (.STL) if tibia is included
Case Report Document
.PDF summarizing surgical planning parameters, measurements, alignment references, and PSI design details
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.