additive

manufacturing
/ biomedical
CEIT Biomedic al Engineer ing, s.r.o.
To ls téh o 3, 0 4 0 11 Košice, Slov akia
+ 42 1 9 49 2 03 0 8 1 + 42 1 9 49 2 03 0 8 2
info@ceit-ke.sk wvw.amimplants.com
engineering
h um a n r e s to r at i o n, a r t o f im p l a nto l o g y
the institute was established as a spin-off organization of the mother
company CEIT a.s. and the Technical University of Košice

our team includes experts qualified in the field of biomedical engineering

with close relations to scientific and academic environment

we develop new solutions with the focus on consulting,

development and manufacturing in the field of 3D printing:

free form manufacturing research

modelling of cer tif ied & development
& development medical products, of medical
of prototypes custom-made products
& in series
p ro duc t s an d s er v ice s
*AM - a process of joining materials to make objects from 3D model data, usually layer upon layer (A STM F 2792 - 12a)

custom implants made of titanium alloy (Ti-6AI-4V) (Grade 5)

manufactured by the 3D printing technology

plastic and metal prototypes manufactured by the 3D printing

technology, manufacture of anatomic models

3D scanning, digitalisation and modelling

of medical products

medical data processing and adjustment

verification and validation of medical products

medical metrology and diagnostics

science and research in the field of implantology, *A M/ s tep b y s tep

implant manufacturing and medical sensorics
process of development and manufacturing of a custom-made cranial implant
applying the additive technolog y
 diagnostics input data (C T, MRI) referential model additive manufacture (AM) postprocessing implant Ti-Al6 -V4 (Grade 5)

implant modelling 3D printing of prototypes consulting validation-metrotomography surger y after the reconstruction
“no words
can express
my gratitude“
Milan Koky

14 months after the surger y AM facilitates the creation of custom-made implants for the entire human skeletal apparatus
 we have created a custom-made implant,
for the patient with the defect in the ex tent surgically inser ted by the team of physicians
of 34% of the cranial skull area of the L. Pasteur University Hospital in Košice
as soon as 3 months after the surger y, after 9 years on a wheelchair, 100%
he began to acquire the lost communication dependent on other people’s assistance,
skills, as well as mobility today he is happy to return to the full life
custom-made cranial implant inter vertebral spinal brace

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facial restor ation

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the most extensive maxillofacial implant manufactured applying the AM in the history of the industry
jaw joint prosthesis body pelvic prosthesis
01/ a patient with an ex tensive defect in the facial and ma xillofacial area 03/ f inal implant model was preceded by several development stages

04/ the patient is currently after the most demanding surger y,

02/ 4 various sources of anatomical data were used for the restoration 3 subsequent inter ventions are planned to complete the restoration
m at e r i al T i - A l 6 -V4 (G r ad e 5 ) p o ro us s t r u c t ur e s
comparison of selected medical materials used for the implant manufacturing AM facilitates the manufacture of implants with the porous structure that enables us to create
implants with physical properties very similar to human bone properties
14
13
12
10
this unique structure improves the osteointegration and reduces the implant weight

commercially pure titanium (cp Ti)

commercially pure titanium (cp Ti)

9000 9

p o l y e t h e r e t h e r ke t o n e ( P E E K )

p o l y e t h e r e t h e r ke t o n e ( P E E K )
8000 8
7000 7
z i r c o n i u m d i o x i d e ( Z r O 2)

z i r c o n i u m d i o x i d e ( Z r O 2)
h u m a n b o n e (c o r t i c a l )

h u m a n b o n e (c o r t i c a l )
6000 6

sintered alloy Co - Cr

sintered alloy Co - Cr
T i - 6 A l - 4 V (G r a d e 5 )

T i - 6 A l - 4 V (G r a d e 5 )
hydrox yapatit (HA)
5000 5
4000 4

stainless steel

stainless steel
3000 3
2000 2
1000 1
0 0

density (kg/m ) 3
thermal conductivity (W/m.K)
commercially pure titanium (cp Ti)

commercially pure titanium (cp Ti)

p o l y e t h e r e t h e r ke t o n e ( P E E K )

p o l y e t h e r e t h e r ke t o n e ( P E E K )
z i r c o n i u m d i o x i d e ( Z r O 2)

z i r c o n i u m d i o x i d e ( Z r O 2)
1400
h u m a n b o n e (c o r t i c a l )

h u m a n b o n e (c o r t i c a l )
sintered alloy Co - Cr

sintered alloy Co - Cr
1200
T i - 6 A l - 4 V (G r a d e 5 )

T i - 6 A l - 4 V (G r a d e 5 )
hydrox yapatit (HA)

hydrox yapatit (HA)

1000 250
800
stainless steel

stainless steel
200
600 150
400 100
200 50
0 0

yield strength (MPa) elasticity modulus (GPa)

* source: CEIT Biomedical engineering

properties of titanium alloy Ti-6Al-4V (Grade 5) – it currently belongs to the best material used in the implant manufacturing porous structure is manufactured with various geometric shapes and pore sizes

light, with relatively high strength (strength to the material density) yield strength: 1.150 ± 60 MPa
corrosion resistance characteristic stress: (Rp 0.2%) 1.030 ± 70 MPa
biocompatibility extension at disturbance: 11% - 2%
very good bioadhesion young’s modulus of elasticity: 110 ± 7 GPa (16 ± 1 msi)
surface roughness (depending on the manufacture parameters): hardness: 400 – 430 HV (41 – 44 HRC)
Ra 9 – 12 µm, Rz 40 – 80 µm maximum temperature at long-term load: 350°C (660°F)
pr intibilities research and development
the „printibilities“ consulting program provides the consulting in the field of optimisation design and development of porous structures in implants
of manufacturing processes by the additive manufacturing implementation

computer-assisted simulation of mechanical

planning, selection of the equipment for the AM, workplace
and thermal load of custom-made implants
equipments, staff training, consultations

development of prototypes in various industries application of microsensors into implants and medical products
other then biomedical engineering

we cooperate with prestigious research and education institutions development of bioactive f ilms on implant sur face
based in our country and abroad:

development of unique 3D bioprinter

Technical Louis Pasteur BNICE, development of new biomaterials for the 3D printing
University in Hospital development
Košice in Košice & applications

alginate beads with chondrocytes

p ar t n e r s ce r t i f i c at e s

used material Ti-Al6-V4 (Grade 5) titanium alloy meets all the eligibility criteria for the long-term
implantability as specified by the ISO 5832-3, ASTM F1472 and ASTM B348,
and possesses the required biocompatible and mechanical properties

ISO 9001:2008 data digitalisation and component manufacture applying

the additive manufacture technology and the 3D print
project management

ISO 13485:2003 design, manufacture and sale of custom-made medical devices

technical area: inactive functional implants
medical device classes IIb and III

the company is the approved manufacturer of custom-made medical devices:

the State Institute for Drug Control (ŠÚKL) code – SK-13-0224

approved custom-made medical devices:

custom-made cranial implant P91710
custom-made maxillofacial implant P91709
custom-made craniomaxillofacial implant P91708

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