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About us

An engineering and manufacturing company

Bonabyte has been bringing digital technology and 3D printing into healthcare since 2020. We are not a distributor — we combine software development, an engineering design office and our own manufacturing of custom-made medical devices.

Bonabyte patient-specific titanium plates and screws
Patient-specific devices and fixation
since 2020
in digital medicine and 3D printing
4500+
devices planned and delivered since 2021
550+
cases in 2024
State register
custom-made device manufacturer since 2024
Who we are

Engineers and manufacturing, not a middleman

Reconstructive, aesthetic and post-traumatic surgery is complicated by the individual characteristics of each patient. It matters that the surgeon has the support of technical specialists and manufacturing capability across a range of materials and methods. We cover the whole route: from DICOM and segmentation to the finished device and postoperative follow-up.

Working with an engineering team does not constrain the surgeon but extends what they can do: more control, more confidence and a more predictable result.

Bonabyte post-traumatic contour implants
Bonabyte post-traumatic contour implants
Team and infrastructure

Three pillars of the company

IT and design office

A team of bioengineers, process engineers and developers. Design of constructs of any complexity and geometry within optimal timeframes, with continuous development of the BonaPlanner software.

Manufacturing site

Certified manufacturing of custom-made medical devices with high-quality post-processing. SLM titanium printing, PEEK and photopolymer guides.

Clinical support

CT review, engineering advice on complex anatomy, cadaver courses and support for a surgeon's first cases.

Registration and quality

Legal and regulatory framework

We operate as a registered manufacturer of custom-made medical devices and are continuously expanding our evidence base and registrations.

Register of custom-made device manufacturers

Entries No. 31–33 dated 03–04.07.2024 — Roszdravnadzor. Verify ↗

Resident of the MSU technology park

Research and technology infrastructure and development environment.

RZN registration certificate 2022/16943

Roszdravnadzor registration certificate for the BonaPlanner software, including the 2D and 3D modules.

Certified manufacturing

The production cycle meets the requirements for manufacturing custom-made medical devices.

Biocompatible materials

Medical-grade Ti-6Al-4V titanium, PEEK and photopolymers used in medical devices.

CT/MRI compatibility

The devices are compatible with imaging follow-up; PEEK is radiolucent.

For healthcare professionals. This information does not constitute a public offer or medical advice. A medical device may be used only as prescribed by a physician; contraindications exist and an individual assessment of the clinical situation is required.
Evidence base

What the clinical data shows

We rely on the international evidence base and do not promise a guaranteed clinical outcome. An example relating to subperiosteal implants:

97,1%

Implant survival at 5 years (n=150).

Zielinski et al., J Clin Med 2025;14:661

95,2%

Survival with partial rehabilitation, median 36 months.

Vaira LA et al., JOMS 2025;83(6):728–737

data

Risk factors for exposure — for preoperative assessment by the surgeon.

Van den Borre C et al., IJOMI 2024;39:302–309

Clinical collaboration

Experience of working with medical institutions

Our experience of clinical collaboration and use of Bonabyte solutions includes work with federal, municipal and private medical institutions — cancer centres and neurosurgical, maxillofacial and orthopaedic services.

Blokhin National Medical Research Centre of Oncology
Clinical Hospital No. 1 (Volynskaya)
Priorov National Medical Research Centre of Traumatology and Orthopaedics (CITO)
Turner National Medical Research Centre for Children's Orthopaedics and Trauma Surgery
Vishnevsky Central Military Clinical Hospital
Vladimirsky Moscow Regional Research Clinical Institute
Vreden National Medical Research Centre of Traumatology and Orthopaedics
Sechenov University
Petrovsky National Research Centre of Surgery
Sklifosovsky Research Institute for Emergency Medicine
Russian Children's Clinical Hospital (RCCH)
GALAKTIKA Institute of Beauty
Burdenko National Medical Research Centre of Neurosurgery
Dmitry Rogachev National Medical Research Centre of Paediatric Haematology, Oncology and Immunology
Herzen Moscow Oncology Research Institute
Central Research Institute of Dentistry and Maxillofacial Surgery
Loginov Moscow Clinical Scientific Centre
Burdenko Main Military Clinical Hospital

The logos are shown as a list of medical institutions with which we have experience of clinical collaboration and use of Bonabyte solutions. Trade marks belong to their respective owners. This does not indicate partnership, affiliation or endorsement by the organisations listed.

Data security

Patient data is protected

  • CT transfer and processing — in accordance with Federal Law 152-FZ
  • For the review, a DICOM without identifying patient data is sufficient
  • Cases are published only in de-identified form and where consent has been obtained
  • Case materials are accessed through the physician's BonaPlanner account
Documents

Documents and certificates

Registration and legal documents are provided on request and updated as they are received.

RZN registration certificate 2022/16943

Roszdravnadzor registration certificate for the BonaPlanner software, including the 2D and 3D modules. A copy is available on request.

State register of custom-made device manufacturers

Confirmation of listing in the register of custom-made medical device manufacturers is available on request.

Privacy policy →

Personal data is processed in accordance with Federal Law 152-FZ.

Terms of use →

Terms for the provision of services and manufacture of devices.

Quality management system certificates and other documents will be added once provided by Bonabyte.

FAQ

FAQ

Bonabyte has been bringing digital technology and 3D printing into healthcare since 2020. Forty clinics work with Bonabyte solutions and more than 4,500 clinical cases have been completed (company data).

Since 2024 the company has been listed in the state register of custom-made medical device manufacturers and is a resident of the MSU technology park. The BonaPlanner software holds Roszdravnadzor registration certificate RZN 2022/16943, which covers both the 2D and 3D modules.

A Russian-speaking team of bioengineers, process engineers and developers. Devices are designed in our own design office and manufactured at a certified production site. The clinical decision remains with the surgeon.

CT transfer and data processing follow Federal Law 152-FZ. Cases are published only in de-identified form and where consent has been obtained. For a review, a DICOM without identifying patient data is sufficient.

Devices and renders

Bonabyte manufacturing

Range of patient-specific plates
Set of patient-specific titanium guides
TMJ ramus prostheses
TMJ ramus prostheses
Abutments and fixation
Abutments and fixation
Fixation screws
Fixation screws
Anodised plate
Anodised plate
PEEK prosthetic restoration
PEEK prosthetic restoration
Trial-fit models
Trial-fit models

Bonabyte device images and 3D renders. Manufactured individually from the patient's CT.

Ready to discuss cooperation?

Send a CT for review or request a presentation for your clinic — a Bonabyte engineer will get in touch.

The information on this website is intended for healthcare professionals and does not constitute medical advice, a public offer or a guarantee of clinical outcome. Bonabyte devices are custom-made medical devices designed for a specific clinical task; their applicability depends on the CT data, the anatomy, the condition of the soft tissues, the surgical access and the operative plan. The final decision on the use of a device is made by the treating physician. Contraindications exist and an individual assessment of the clinical situation is required.