Custom Biocompatible Cranial Implant

A complete 5-stage digital workflow: retopology of the CT scan to extract the cranial geometry, implant design in Autodesk® Fusion™ and tooling design in Autodesk Inventor® in a coordinated workflow, 3D printing of disposable fixtures, toolpath programming in Powermill® and 5-axis CNC machining in PEEK Optima® with ±0.02 mm tolerance. Medical approval before manufacturing.

Each step removes a source of error. The result is an implant the surgeon can place in 2.5 hours on average, with no improvisation.

01 · Data Extraction — CT Scan Retopology. The process starts with the patient's computed tomography (CT scan). The DICOM® point cloud is processed through retopology to extract the exact cranial geometry —including the bone defect and adjacent structures— producing a clean, parametric polygon mesh. This digital dataset is the foundation of the entire engineering chain: without exact data, there is no exact implant. (CT scan → Point cloud → STL mesh)

02 · CAD Design of Implant and Tooling — Autodesk Fusion + Inventor. The cranial mesh is imported into Autodesk Fusion for parametric implant design: exact fit to the bone defect, volumetric compensation for tissue loss (Natura P®) or standard anatomical reconstruction (Natura S®), asymmetry correction and design of the microplate anchors. The machining-specific workholding fixtures are designed on the same platform, eliminating the need for additional software or processes. (Autodesk Fusion · product design + Autodesk Inventor · tooling design, in a coordinated workflow)

03 · Tooling Fabrication by 3D Printing — Disposable Fixtures. The fixtures and tooling designed in Inventor are produced directly by additive manufacturing (FDM). Because they are single-use, disposable parts, the cost and lead time of conventional metal tooling are eliminated. Each fixture is optimized for the specific geometry of each patient's implant, ensuring perfect workholding during machining and preventing vibration or shifting that would compromise the final tolerance. (3D printing · Disposable fixtures · Zero tooling cost)

04 · 5-Axis CNC Programming — Toolpaths in Powermill. The implant CAD model is imported into Autodesk Powermill to generate the 5-axis machining strategies. Roughing, semi-finishing and finishing toolpaths are calculated, optimizing tool orientation to reach every complex surface of the skull —including undercut zones— without repositioning. Virtual simulation in Powermill confirms there are no collisions between tool, holder and fixture before the program runs on the machine. (Powermill · 5 axes · Collision simulation)

05 · 5-Axis CNC Machining in PEEK Optima® — ±0.02 mm Tolerance. The implant is machined from a block of PEEK Optima® (certified medical grade) on a 5-axis CNC mill. Simultaneous 5-axis capability reaches all of the skull's organic geometry in a single setup, holding ±0.02 mm across the entire surface. The result is an implant that fits the patient's bone defect with sub-millimeter precision, reducing fitting time in the operating room to practically zero. (5-axis CNC · Medical-grade PEEK Optima® · ±0.02 mm)

A digitally designed implant removes improvised decisions in the operating room. The surgeon knows the exact approach before entering the OR, reducing surgery time by more than 50% compared with traditional techniques.

A medical implant without regulatory approval cannot be implanted. Every PEEK implant we manufacture operates under an active sanitary registration.