Technical Specifications
Complete technical reference.
Every specification you need to evaluate, procure, and integrate the Patient-Matched Skull Reconstruction System. For deeper technical content, see ME-Fab® platform and standards compliance.
Product Identification
Identification & configuration.
| Item | Detail |
|---|---|
| Product name | Additive Manufacturing Patient-Matched Skull Reconstruction System |
| Models | DLZ04 · DLZ05 |
| Size range | 30 – 200 mm |
| Indications | Cranial defect repair & reconstruction |
| Patient type | Adult & paediatric (size-dependent) |
| Customisation | Patient-matched from CT/MRI DICOM |
| Usage | Single patient, single use |
| Class | Class III implantable |
| Item | Detail |
|---|---|
| Registration cert. | 国械注准 20263130176 |
| Cert. holder | Shenzhen Excellent Technology Co., Ltd. |
| Manufacturer | Shenzhen Excellent Technology Co., Ltd. |
| Manufacturer site | 10B Kechuang Building, Quanzhi Tech Park, Bao'an, Shenzhen |
| UDI carrier | Human- and machine-readable per MDR Annex VI / 21 CFR 801 |
| Basic UDI-DI | CRANIO-PSI-3D-PEKK-FAM (proposed per MDR) |
| GMDN / EMDN | 61439 / EMDN P04029901 |
| Lead time | 5–7 working days · 3 days expedited |
Material & Biological
Medical-grade Ti-6Al-4V ELI.
| Item | Specification | Standard |
|---|---|---|
| Powder | Ti-6Al-4V ELI, gas-atomised, spherical | ASTM F136, ASTM F3301 (powder) |
| Particle size distribution | 45 – 105 µm | ASTM B214, ISO 13322-1 |
| Oxygen in finished part | < 2,000 ppm | ASTM F136 / ISO 5832-3 |
| Surface roughness (post-EBM) | Ra 5 – 15 µm (as-built) | ISO 4287/4288 |
| ELI specification | O ≤ 0.13% · N ≤ 0.03% · Fe ≤ 0.25% · H ≤ 0.0125% | ASTM F136 / ISO 5832-3 |
| Screw material | TC4 titanium (Ti-6Al-4V) | GB/T 13810 |
| Post-processing | Stress relief (730 °C / 2 h / vacuum) or HIP (900–950 °C / 100 MPa / 4 h / Ar) | ASTM F3301 |
| Final cleaning | Ultrasonic + nitric acid passivation | ASTM F86 |
| Biocompatibility | Full ISO 10993 panel | ISO 10993-1 to -22 |
| Surface chemistry | Native TiO₂ · Ti-OH groups for protein adsorption | — |
Manufacturing & Micro-Architecture
EBM parameters and the gradient porous structure.
| EBM Parameter | Value |
|---|---|
| Vacuum | < 1 × 10⁻³ mbar |
| Beam voltage | 60 kV |
| Beam current | 3 – 30 mA (function-graded) |
| Scan speed | up to ~10⁴ mm/s |
| Layer thickness | 50 – 100 µm (default 70 µm) |
| Pre-heat | 700 °C |
| Oxygen in chamber | < 50 ppm |
| Powder reuse limit | ≤ 20 cycles |
| Micro-Architecture Parameter | Value |
|---|---|
| Porosity (bone-contact) | 60 – 80% |
| Porosity (load-bearing) | 20 – 40% |
| Pore size | 300 – 800 µm (Bobyn window) |
| Strut thickness | 200 – 500 µm |
| Interconnectivity window | ≥ 100 µm (Klawitter-Hulbert threshold) |
| Density (after HIP) | ≥ 99.5% |
| Surface treatment | Passivation ASTM F86 |
| Surface structure | Biomimetic dual-surface (porous / smooth) |
Mechanical Performance
Lab data and acceptance criteria.
| Test | Method / Standard | Our result | Industry benchmark |
|---|---|---|---|
| Quasi-static compressive failure | ASTM F382 | 1,400 N peak | Mesh ≈ 40 N |
| Impact deformation | Internal drop rig | < 0.7 mm, full elastic recovery | Mesh > 7 mm permanent indent |
| Fatigue (5 Hz, R = 0.1, 37 °C SBF) | ASTM F382 / ISO 14801 | ≥ 5 × 10⁶ cycles | Mesh < 10⁶; PEEK < 5×10⁵ |
| Tensile strength (finished) | ASTM E8 | ≥ 860 MPa UTS, ≥ 795 MPa YS | Wrought ELI ≥ 860 MPa |
| Elongation | ASTM E8 | ≥ 10% | ELI spec ≥ 10% |
| FEA — peak von Mises | Patient-specific | < 440 MPa | — |
| FEA — interfacial micromotion | Pilliar threshold | < 50 µm | — |
| FEA — stress-shielding ratio | Implant ÷ bone strain | 0.7 – 1.3 | — |
Sterilisation & Packaging
Validated to international standards.
| Process Step | Specification | Standard |
|---|---|---|
| Part removal | Wire EDM | Internal SOP |
| Surface finishing | CNC trimming, drill/tap interfaces | Internal SOP |
| Passivation | Nitric acid | ASTM F86 |
| Cleaning | Multi-stage ultrasonic + DI rinse | Internal SOP |
| Inspection | 100% CMM dimensional check vs. design STL | ISO 10360 |
| Conformity | CT scan of finished part vs. design STL | Internal SOP |
| Labelling | UDI carrier (human + machine) | MDR Annex VI; 21 CFR 801 |
| Process Step | Specification | Standard |
|---|---|---|
| Sterilisation | EO (default) or gamma | ISO 11135 / 11137 |
| Packaging | Double-pouch + Tyvek, ISO Class 7 cleanroom | ISO 11607-1/-2 |
| Shelf life | 5 years from sterilisation | Validated by accelerated aging |
| Storage | Dry, room temperature, protect from light | IFU |
| Transport | Validated ISTA 3A distribution cycle | ISTA 3A |
| Lead time | 5–7 working days · 3 days expedited | — |
| Spare implant | ±10% size backup shipped together | — |