ABOUT TECHNOLOGY

The production model we use and selected materials have been validated by FDA representatives as eligible for 510(k) certification, which does not require mandatory clinical studies.

AREAS OF APPLICATION:

Traumatology & Orthopedics

Neurosurgery

Maxillofacial Surgery

Plastic Surgery

Oncoreconstruction Surgery

Pediatric Surgery

PRECLINICAL RESEARCH DATA

Our materials have undergone preclinical studies in accordance with ISO 10993 standard

FUTURE TECHNOLOGY FOR PHYSICIANS

1. Implant modeling

The model is developed based on MRI/CT scans and physician prescription. Each product is accompanied by a surgical model.

2. Implant production

The modeled 3D implant is manufactured using biodrook’s own equipment. We do not outsource your order to another manufacturer.

Production after modeling takes up to 4 hours for non-resorbable polymer products and up to 48 hours for resorbable polymer products, which is significantly faster than traditional methods. Sterilization is ensured and meets implant sterilization requirements (SAL 10⁻⁶). Total manufacturing time including sterilization — up to 24 hours.

The product is delivered to the surgeon sterile with a complete set of relevant documents. The use of biopolymer materials and 3D printing reduces costs compared to patient-specific titanium-based implants.

3. Implantation and restoration

Sterile implants are delivered directly to surgeons and ready for use in the operating room. Processes are backed by a quality management system guaranteeing safety, efficacy and high product quality.

Presentation