Additive Manufacturing Patient-Matched Skull Reconstruction System
The world's first patient-matched Class III cranial implant validated by a large-cohort prospective clinical study. Sub-millimetre anatomical match, gradient porous micro-architecture, < 2% total complication rate.
Why surgeons choose the Skull Reconstruction System.
Perfect anatomical match
Every cranial defect is unique. Off-the-shelf titanium mesh and PEEK plates force the surgeon to manually bend, cut, and trim. Our implant is reverse-engineered from the patient's own CT/MRI — sub-millimetre accuracy on first placement.
Outstanding biocompatibility
Native TiO₂ oxide layer carries Ti-OH groups that bind protein hydroxyl side-chains through hydrogen bonds and Ti-O-R covalent bonds. The molecular basis for titanium's long-term in-vivo stability.
Operability / surgical efficiency
Medicine-Engineering Interaction (MEI) — the surgeon and our medical engineer sign off on the design before the patient is on the table. No "discovering" geometry intra-operatively.
Natural aesthetic outcome
1:1 cranial curvature restoration with smooth transition curves and midline symmetry. Post-op facial symmetry, self-confidence, and quality-of-life metrics recover together.
Clinical evidence — < 2% complications
The first PSI CMF implant validated by a large-cohort prospective clinical study. Total complication rate < 2% vs. 12–18% for conventional mesh / PEEK.
CT & MRI compatibility
Multi-applicable, multi-modal imaging: porous design reduces CT artifacts. MRI-safe (non-magnetic, mild and safe heat). Clear post-op imaging enables easy follow-up.
One-of-a-kind. Literally.
These mechanical performance numbers are not just better than mesh and PEEK — they are at the upper boundary of what biomimetic engineering can achieve for cranial reconstruction.
Compressive failure strength
vs. ~40 N for titanium mesh and PEEK
Max deformation, full elastic recovery
vs. > 7 mm permanent indent for mesh
Fatigue cycles to failure
vs. < 10⁶ for mesh; < 5×10⁵ for PEEK
The numbers that change the conversation.
| Endpoint | Excellent MedTech 3D PSI | Titanium mesh | PEEK plate |
|---|---|---|---|
| Total complication rate | < 2% | 12.2 – 17.4% | 17.2 – 18.5% |
| Infection | < 1.7% | 6.05 – 8.2% | 5.1 – 8.8% |
| Re-operation (critical failure) | None observed | 3.70% | 8.60% |
| Subcutaneous effusion | None observed | 9.1 – 18.9% | 28.6 – 33% |
| Implant exposure | None observed | 2.1 – 5.8% | 0.8 – 2.2% |
| Chronic headache / foreign-body pain | None observed | 12 – 18.5% | 5.0 – 7.1% |
| Loosening / migration | None observed | 1.1 – 3.8% | 1.0 – 3.1% |
| CT artifacts | Reduced by porous design | Present, acceptable | None, but blurry |
| MRI safety | Safe, mild heat | Safe, mild heat | Safe, no heat |
Source: large-cohort prospective clinical study (5,000+ cases) vs. peer-reviewed literature controls.
From CT to sterile implant in 5–7 working days.
Send CT
DICOM upload + defect description
Design
Image recon · biomimetic design · FEA
MEI sign-off
Surgeon-engineer review
Manufacture
EBM build · post-process · inspect
Deliver
Sterile pack · DHL/FedEx
Tested in 50+ clinical partner sites.
Our clinical partners include the Fourth Military Medical University, Southern Medical University affiliated hospitals, Shenzhen Second People's Hospital, Beijing Tiantan, Huashan, Xuanwu, and 500+ other sites across China.
"The MEI workflow changes the surgical experience. By the time the patient is on the table, the geometry is no longer a surprise — it's an execution."
— Senior neurosurgeon, Class III academic hospital, China
"For large bifrontal defects, the patient-matched geometry with porous bone-contact surface is the difference between a 90-minute surgery and a 3-hour surgery."
— Chief of neurosurgery, southern medical university affiliated hospital
Start a patient case.
Our team responds to clinical intake within 24 hours. Hospital distributors, send your surgeon to the form. Direct inquiries welcome.