Manufacture of patient-specific skull implants (cranioplasties) made of PEEK, BIOVERIT®II and titanium as well as medical practice models
3di GmbH
07749 Jena (Löbstedter Str. 41)New on Amplifa
About 3di
The 3di GmbH is a medical technology company from Jena that has been manufacturing patient-specific implants for the facial and cranial skull area since 2000. The main product is cranioplasties individually adapted to the patient's defect, which are used after trauma, tumor surgery, decompressive craniectomies or for functional-aesthetic corrections. Implant planning is carried out virtually on the basis of the patient's CT data; manufacturing takes place in the in-house manufacturing center with a production accuracy of less than 0.5 mm – usually within around three working days, and within 48 hours in emergencies. In addition to three implant materials (PEEK, BIOVERIT®II, titanium Ti6Al4V), resection templates and DICOM data sets for neuronavigation systems are produced from these materials. The portfolio is complemented by patient-specific and non-specific hard-tissue and soft-tissue models for surgical planning, training and research, developed jointly with the ENT university hospitals of Jena and Ulm. Patients in more than 10 countries are supplied with implants from Jena.
- Site
- Jena
- Processes
- Patient-specific implants (cranioplasties) for the facial and cranial skull area, machined, In-house process for manufacturing patient-specific implants in the in-house manufacturing center, Hard-tissue models (skull models incl. template, petrous bone models, osteotomy models,, Soft-tissue models (flap surgery, rhinoplasty, lip and auricular reconstruction models, individual, Virtual implant planning and design, creation of resection templates, provision, Patient-specific implants (cranioplasties) for the facial and cranial skull area, Design/implant planning, Resection templates
- Materials
- PEEK (PEEK-OPTIMA® / PEEK-VESTAKEEP®), BIOVERIT®II (machinable glass ceramic, SiO2-Al2O3-MgO-Na2O-K2O-F system), Titanium alloy Ti6Al4V, Synthetic resin based on acrylate (methacrylate) for hard-tissue models, Silicone (soft-tissue models, 5–10 mm layer thickness), Powder materials (basis for skull models), BIOVERIT®II (machinable glass ceramic), Synthetic resin based on acrylate (methacrylate)
- Certificates
- EN ISO 13485:2016 + AC:2018 + A11:2021, MDR 2017/745 certificate (Annex IX), EN ISO 13485, MDR 2017/745 (Annex IX)
- Founded
- 2000
- Industries
- Medical technology, Neurosurgery, Otolaryngology (ENT), Oral and maxillofacial surgery, Plastic reconstructive and aesthetic surgery, Trauma surgery
- 01
CT data transmission (web upload, CD/DVD, data portal)
- 02
Incoming data inspection
- 03
Virtual implant planning and design
- 04
Manufacturing in the in-house manufacturing center
- 05
Delivery incl. cleaning and sterilization instructions
- 06
Provision of DICOM data set for neuronavigation (on request)
Implant Materials & Processes
PEEK (PEEK-OPTIMA® / PEEK-VESTAKEEP®)
Non-resorbable high-performance thermoplastic for long-term implantation, machinable, radiolucent (no artifacts in X-ray, CT, MRI).
BIOVERIT®II (machinable glass ceramic)
Biocompatible, bioinert glass ceramic of the SiO2-Al2O3-MgO-Na2O-K2O-F system with bone-like thermal conductivity, machinable.
Titanium alloy Ti6Al4V
Highly stable, long-proven implant metal that enables very thin implant geometries; passivated by a protective oxide layer.
Synthetic resin based on acrylate (methacrylate)
Material for hard-tissue models, steam-sterilizable on request and suitable for short-term use on the patient.
Silicone (5–10 mm layer thickness)
Replicated skin or cartilage thickness for soft-tissue models for suturing practice, base plates can be recoated.
Locations
Jena
DEHeadquarters, production, 3D printing center
- Lot size
- One-off production (patient-specific)
- Materials
- PEEK, BIOVERIT®II, Ti6Al4V, acrylate, silicone
- 3D printing center (3D printers, 2019/2020)
Components & Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Patient-specific implants (cranioplasties) for the facial and cranial skull area, machinedMachining | Production accuracy < 0.5 mm | – | – | – | PEEK, BIOVERIT®II, Titanium (Ti6Al4V) |
| In-house process for manufacturing patient-specific implants in the in-house manufacturing centerAdditive | Production accuracy < 0.5 mm | – | – | – | PEEK, BIOVERIT®II, Titanium (Ti6Al4V) |
| Hard-tissue models (skull models incl. template, petrous bone models, osteotomy models,Plastics | – | – | – | – | Synthetic resin based on acrylate (methacrylate), Powder materials |
| Soft-tissue models (flap surgery, rhinoplasty, lip and auricular reconstruction models, individualPlastics | – | – | – | – | Silicone, Synthetic resin based on acrylate (methacrylate) |
| Virtual implant planning and design, creation of resection templates, provisionEngineering | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| 3D printing center (3D printers) | – | – | – | 2019/2020 | Jena |
Additional services
Reference customers
Certification & Quality Management
The 3di GmbH is certified according to EN ISO 13485:2016 + AC:2018 + A11:2021 in the areas of development, manufacturing and distribution of hard-tissue replacements. The patient-specific skull implants meet the requirements of MDR 2017/745; an MDR certificate according to Annex IX is available.
| Evidence | Jena |
|---|---|
| EN ISO 13485 | |
| MDR 2017/745 (Annex IX) |
History
- 2000
End of the research project and founding of 3di GmbH; 1st prize in the 3rd Thuringian Business Plan Competition and 1st Thuringian Idea Oscar
- 2002
Market launch of the petrous bone models
- 2007
Market launch of skull models based on powder materials as well as postcranial models
- 2008
Production of patient-specific skull implants made of PEEK-OPTIMA®
- 2009
Introduction of the implant material PEEK-OPTIMA®
- 2011–2015
Market launch of auricular reconstruction, flap surgery and rhinoplasty models as well as lip model; 2014 new production capacities, expansion of R&D
- 2017–2018
New/additional template materials, market launch of skull models based on acrylate
- 2019–2020
3D printing center and machinery expansion, relocation to a larger company building
- 2025
25 years of 3di GmbH