Ortho Baltic Implants – Patient-specific medical solutions

Ortho Baltic Implants is a trademark owned by the company Ortho Baltic, in market more known as producer of custom-made prosthetic-orthotic devices under the name of Ortho Baltic, in 2012 we have invested in additive manufacturing technologies and expanded our made-to-order services to the design and production of patient-specific joints, cranial and spinal implants, bone plating systems, dental & jaw restoration implants and patient-specific surgical guides as well.

Ortho Baltic is pioneer in developing of patient-specific implants in Eastern Europe Region. In manufacturing of patient-specific products, we apply different 3D printing technologies and biocompatible materials such as: titanium (Ti6Al4V), cobalt-chrome (Co-Cr-Mo), Nylon 12 and ceramics powders. Our company employs a team of highly qualified biomechanical, mechanical, material science engineers, physicists and ITC proffesionals, and work closely cooperating with Lithuanian University of Health Sciences, Vilnius University and a number of university’s hospitals. Ortho Baltic carries industrial doctorship studies in partnership with Kaunas University of Technology and also actively participates in European Collective Research Projects, and Horizon 2020 programme.

In 2013 the company received National Award for the Achievements in Science and Business Cooperation. We are closely cooperating with medical institutions in developing new medical devices, to have direct touch with end-users of our products, also Ortho Baltic is running its own specialized Consulting Clinic for patients with orthopaedic issues and subsidiary Baltic RAD (www.balticrad.com) that provides remote radiology reporting services to hospitals, both locally and for export. Ortho Baltic applies mass customization business model in production of medical devices starting from Class I and ending Class III. Our Quality Management System has been approved to ISO 9001, ISO 13485, and ISO 14001 standards. All Ortho Baltic products and services meets the highest requirements of quality and security for medical devices, are registered and have Free Trade Certificates for distribution in EU countries. 99% of our output goes for export. Main markets – Benelux, Scandinavia, Germany and Switzerland.

Technology & Materials

For the design and production of patient-specific medical devices, the company uses only EU certified biocompatible materials and the state-of-the art design and manufacturing technologies. The processes of implants and single-use surgical instrument production are certified by Det Norske Veritas and fully meets the requirements of the ISO 13485 standard. The company’s Centre of Implant Design and Development is the only one in the Baltic States, and also in the entire Central Europe.

For the manufacturing processes of the patient-specific medical devices we use the following technologies:

3D reconstruction

Virtual anatomical 3D reconstruction, also called as 3D segmentation, is performed using certified Materialise Mimics® Medical software. The result is the patient-specific anatomic model of internal organ and / or tissue structure.

3D anatomical reconstruction
3D anatomical reconstruction

Implant design

Virtual implant design is created using Geomagic® Freeform® Plus and other virtual design software. These software use stl, 3dm, wrml, obj, ply, pcl, sldprt, iges and other data input / output formats. The result is models of 3D patient-specific medical devices: implants and single-use surgical guides.

Non-destructive testing

Simulation of the strength characteristics of patient-specific implants is performed applying finite element analysis (FEA) method, using ANSYS® software. The finite element analysis is used to ascertain that the designed patient-specific implant meets the mechanical characteristics that are set out in the applicable standards as well as predict how it will react to the actual environmental conditions.

Manufacturing

The following materials and manufacturing technologies are used to produce patient-specific implants:

  • To manufacture patient-specific implants, we use the additive manufacturing technology DMLS (Direct Metal Laser Sintering) and medical Grade 5 titanium alloy Ti6Al4V powder, which is poured in 30-micron layers and sintered with an optical laser;
  • Some components of patient-specific implants (for instance, the component of the fossa for the temporomandibular joint endoprosthesis) are manufactured from ultra-high molecular weight polyethylene (UHMWPE) using a 5+1 axis milling technology;
  • Single-use patient-specific surgical guides are printed from biocompatible polymer (PA 2200, also known as Nylon-12) using additive manufacturing technology SLS (Selective Laser Sintering).

For the manufacturing of patient-specific implants and surgical guides we use only biocompatible and certified materials. After 3D printing and / or milling, implants are processed using various surface finishing technologies in order to ensure their compliance with the requirements defined by the harmonised product standards.

Surface treatment

For the surface treatment of implants the following technologies are applied: sand blasting, CNC milling, polishing, anodising and other. If required, implant surfaces can be coated with different kind of hybrid coatings (for example, antibiotics-impregnated, hydroxyapatite and / or tricalcium phosphate, etc.).

Quality Control

Patient-specific implants that come with patient-specific surgical guides are class IIb to III medical devices; therefore, their validation and verification are performed in all the product development stages in comply with the requirements of the ISO 13485 standard. To meet the standard requirements, during the final product quality control, the implant undergoes analysis of the geometry, surface roughness, internal defects and chemical composition. These analyses are performed using industrial micro CT NIKON XT H 225, with the accuracy of 10 μm; the CMM (Coordinate Measuring Machine), with the accuracy of 5 μm; surface roughness tester Rugosurfthermo scientific analyzer NITON, and stereomicroscope Olympus.

Medical device sterilization and packaging

The cleaning, washing, disinfection and packaging of patient-specific implants and surgical instruments are carried out in the company’s certified ISO Class 7 cleanroom (ISO 14644). All the implants containing lattice structure in their construction are packaged and sent to a certified institution in Germany for gamma sterilization (ISO 11137). All the other medical devices without lattice structure are sterilized by gamma rays only by request. Otherwise, medical devices are delivered to the healthcare institution prepared for sterilisation in the autoclave: cleaned, disinfected and packaged.

Ortho Baltic Implants offers you the following solutions:

Patient-specific Temporomandibular Joint Endoprosthesis

The temporomandibular joint (TMJ) is the most frequently used joint in the human body; its unique biomechanics allows us to speak and chew. This joint consists of the following two main structures: glenoid fossa and condylar head.
When the temporomandibular joint is damaged as a result of trauma or illness (such as osteoarthrosis, ankylosis, etc.), and usual treatment methods are ineffective or impossible to apply, this joint undergoes replacement surgery – the patient’s TMJ is replaced with an artificial one. This TMJ endoprosthesis is intended to replace a damaged joint, and restore its anatomy and its function. TMJ endoprosthesis may be either standard or patient-specific. In severe cases (for instance, large bone defect / deformity, irregular jaw position, bilateral pathology (both TMJs) or complications of existing implants), the use of a patient-specific TMJ implant is then recommended.
Ortho Baltic manufactures patient-specific TMJ endoprosthesis individually for each patient with regard to the patient’s anatomy, pathology and the surgeon’s specifications for the design and requested set. Patient-specific TMJ implants and patient-specific surgical guides are designed on the patient’s skull-mandible anatomical model that is recreated from CT scan images. If possible, we advise to perform intraoral scan or take dental impressions of patient’s teeth. These highly accurate models are used to design a bite splint (to correctly position the jaws). Therefore, the patient-specific endoprosthesis precisely fits the patient’s anatomy and ensures stable fixation and restoration of anatomical axes. The accuracy (regarding the pre-surgical plan) of resection lines, implant positioning and restoration of occlusion are ensured by using patient-specific surgical guides.

Ortho Baltic is proud to be the first patient-specific TMJ endoprosthesis manufacturer in Baltic States, and one of the few in whole Europe. More read hereAlso we would like to thank prof. dr. Jules Poukenswho participated a lot in creating solution for the our first patient-specific TMJ replacement case!

Manufacturing and materials of Ortho Baltic patient-specific TMJ endoprosthesis

Ortho Baltic is the only manufacturer in Europe that provides registered patient-specific TMJ endoprosthesis. Ortho Baltic patient-specific TMJ endoprosthesis are registered in the State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania. All the materials, software and hardware used to manufacture patient-specific TMJ implants and surgical guides are certified.
For patient-specific TMJ endoprosthesis components we use the following materials and production technologies:

  • patient-specific mandibular (ramus) component is made from medical Grade 5 titanium alloy Ti6Al4V using additive manufacturing technology DMLS;
  • patient specific fossa component is made from ultra-high molecular weight polyethylene UHMWPE using a 5+1 axis milling technology;
  • single-use patient-specific surgical guides, patient-specific anatomical and implant models used in presurgical planning as well as for planning and training purposes during surgeries are printed from biocompatible polymer (PA 2200, also known as Nylon-12), using additive manufacturing technology SLS;

After 3D printing and / or milling, patient-specific TMJ implant components (and surgical guides) are processed using various surface finishing technologies in order to ensure their compliance with the requirements defined by the harmonised product standards. Detailed information about patient-specific implant design, manufacture and validation process are available here.

Composition of Ortho Baltic patient-specific TMJ endoprosthesis package

The package of Ortho Baltic patient-specific TMJ endoprosthesis include the following:

  • Patient-specific TMJ implant – fossa component;
  • Patient-specific TMJ implant – mandibular component;
  • Patient-specific TMJ implant trials for fossa and mandibular components (optional);
  • Patient-specific surgical guides;
  • Patient-specific anatomical and implant models (virtual or materialized) that are intended to be used for presurgical planning;
  • Standard implant fixation screws;
  • Documentation (implant passport, instructions for use, etc.).

To fixate implants to the bone, standard surgical instruments for TMJ primary / revision endoprosthesis surgeries are used. Ortho Baltic either ensures the compatibility of the implant fixation solution with the surgeon’s / healthcare institution’s instruments or provides their own instruments for surgery.

For more information see the official site Ortho Baltic Implants>>

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