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Technical Data Sheet: Distal Radius Fracture

Scan and anatomy requirements, supported cases, outputs and charges for Distal Radius Fracture (DRF) cases.

This data sheet is for surgeons and clinical teams preparing Distal Radius Fracture (DRF) cases. It lists the scan and anatomy requirements, supported cases, platform outputs and the case charges policy.


Case Criteria

Anatomical Requirements

To ensure a successful case for planning and guide creation, the following anatomical requirements must be met:

Radius Requirements

  • Full visibility of the distal radius, including the entire fracture zone and all fracture fragments.

  • Inclusion of sufficient radius shaft length beyond the fracture to allow reliable axis definition.

Ulna Requirements

  • Visibility of the distal ulna, used as a reference for orientation and alignment.

The plate and the guide are planned on the reduced radius. The ulna is shown for reference and is not planned.


Supported Case Types & Region

  • Left or Right Wrist

  • Distal Radius Fracture, including multi-fragment fractures

  • Fracture reduction, plate planning and a radius guide in one case

  • Plan and PSI only (no Case Output Configuration choice)


Unsupported Case Types

  • Cases involving bones other than the distal radius (e.g., elbow, hand, hip).

  • CT scans with severe motion or metal artifacts that obscure the fracture fragments and prevent reliable segmentation.

  • Existing plates or screws in the distal radius that obscure the fracture.

  • Partial datasets missing critical anatomy listed above (e.g., fragments outside the scan).


STL Segmentation Guidelines

Optional upload of .STL segmentation is accepted under the following conditions:

  • Radius STL includes the entire fracture zone and sufficient shaft length.

  • Each fracture fragment should be provided as a separate STL file, so it can be moved during reduction.

  • Ulna should be provided as a separate STL file.

  • STL files should not include pre-implanted components or fixation hardware, unless explicitly uploaded for reference 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

If present, upload your own segmentation as STL


Platform Outputs

After approval, the case outputs include:

  • Anatomical Model Files

    • Radius anatomy model (.STL)

  • Guide Files

    • Radius guide (.STL)

  • Delivery Note

    • .PDF delivery note listing the case outputs

  • DRF cases have no plan report.


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.

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