HOME/ ABOUT TECHNOLOGY
The production model we use and the selected materials have been validated by FDA representatives as being 510(k) certified, which does not require mandatory clinical trials.
HOME / ABOUT TECHNOLOGY
The production model we use and the selected materials have been validated by FDA representatives as being 510(k) certified, which does not require mandatory clinical trials.
Areas of use:
Traumatology and orthopedics
Neurosurgery
Maxillofacial surgery
Plastic surgery
Oncoreconstructive surgery
Pediatric Surgery
Our materials have undergone preclinical studies in accordance with the ISO 10993 standard
1. Implant modeling
The 3D model is developed based on MRI/CT images and a doctor's input. Each product is accompanied by a surgical model.
2. Implant production
The simulated 3D implant is manufactured using biodrook equipment. We do not transfer 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 much faster than traditional methods. Sterilization is provided and meets the requirements for sterilization of implants (SAL 10^-6). The total production time with sterilization is up to 48 hours.
The sterile medical device is handed over to the surgeon with a full set of relevant documents. The use of biopolymer materials and 3D printing reduces the cost compared to patient-specific titanium-based implants.
The production processes are compliant with a quality management system that guarantees the safety, efficiency and high quality of products.
3. Implant Delivery
Sterile implants are delivered directly to surgeons and are ready to use in the operating room.
ADVANTAGES OF BIODROOK IMPLANTS:
Non-toxic and biocompatible
implants that interact safely with the body
Bioresorption
stimulate osteogenesis and are completely replaced by bone tissue
Application variability
suitable for different shapes and applications
Bone implants are just the beginning. Biodrook is working on bioengineering solutions for other types of tissues:
FUTURE POSSIBILITIES
Bone implants are just the beginning. Biodrook is working on bioengineering solutions for other types of tissues:
Cartilage
Vessels
Skin
Ligaments
Heart Valves
Start creating the future of affordable biotechnology with biodrook today!