IPS Implants®

One Patient. One Solution.

[Link]
Oral and maxillo-facial surgery is our passion!
Its further development, together with our
customers, is our ambition. Every day we work
on developing innovative products and services
which meet the highest demands on quality,
and which contribute to the wellbeing of
the patient.
IPS Implants®: as individual as your patients!

Contents

­­ Pages
IPS Implants® – Product Features 4-5
KLS Martin Manufacturing Technology 6 - 11
Indications 12
Order/Project Handling 13 - 15
Example Applications 16 - 21
The IPS ® Product Family 22 - 23

3
 IPS Implants®: product features

Patient-specific Implants
and anatomical Models

The loss of complex or extended bone structures due to trauma

or tumor involves considerable physical and emotional stress for
patients, while leaving the physician carrying out treatment with
the consideration of how the defect can be covered in the best
possible way.

IPS Implants® can be an effective solution in this situation, helping

to overcome these difficulties and the resulting uncertainties.

4
 Prof. Dr. Dr. Peter Keßler
Department of Oral and
Maxillofacial Surgery,
Academic Hospital Maastricht

“Our hospital in Maastricht

has been working with patient-
specific implants to cover cranial
defects for some time. The high
degree of safety in planning,
the significantly shorter opera-
ting times, and the improved
aesthetic and functional results
definitely justify the additional
planning input that‘s initially
required.”

Advantages for Patient

and Physician For the Healthcare System

Pre- and intraoperatively Postoperatively

■ No need for autologous bone ■ Perfect mechanical protection ■ Solution for patients not previously
grafts or a second surgical site for the brain or poorly covered
■ Significantly shorter operating times ■ Lower risk of rejection ■ Significantly shorter operating times
■ Lower complication rate ■ Faster rehabilitation ■ Lower complication rate
■ Minimally invasive procedure – ■ Restoration of original appearance ■ Shorter hospital stays
targeted intervention that protects ■ Improved quality of life ■ Reduced overall treatment costs
surrounding tissue structures ■ Faster rehabilitation

5
 KLS Martin manufacturing technologies

Comprehensively varied –
KLS Martin Group Production Technology

Case planning by KLS Martin Case planning by the user

Patient-specific reconstructions and trauma treatments are very complex and

differ greatly from one patient to another. Therefore, it is essential for clinical
partners to enjoy the support of a service provider offering its own manufacturing
capabilities in addition to the complete range of materials and manufacturing
methods.

Whether deep drawing, milling, turning or machining, whether anatomical models

or absorbable material in clean room technology, whether selective laser sintering
or laser melting: The extraordinary diversity of requirements for an individual
implant requires a supplier who combines everything under one roof.

The KLS Martin Group has decades of experience in the processing and
remodeling of metals, plastics and resorbable materials. The new, generative
manufacturing processes present completely new options for clinical users.
In addition to the well-known large implants, which are often used for cranial
and brain injuries, today we are also able to produce patient-specific
“tailor-made” complex, small implants for use in reconstruction. This means
that without a significant lead time, tools, or devices, we can offer our customers
perfectly fitting implants for routine traumatology interventions, which fit
when it really matters!

6
Production in clean room Target/actual comparison Metrology QA and documentation
technology

KLS Martin Range of Services:

■ Complete design
■ Accepting your datasets and joint non-binding discussion
of a solution to the problem (e.g., online meeting)
■ Three-dimensional virtual presentation of the defect reconstruction
■ Conventional manufacturing technology (milling, turning,
deep-drawing, machining, etc.)
■ Resorbable materials in clean room technology
■ Anatomical models
■ Generative manufacturing procedures (laser melting
and laser sintering)
■ Quality assurance and validated process flows
■ Non-binding consultation with qualified sales staff

7
 New: Additive Manufacturing

New
Additive Manufacturing (AM-Titanium)

0 2 3 4

Virtual projection of, for example, orbital floor ... and their actual manufacturing Osteoconductive open support
implants in the workroom on the model

Additive Manufacturing (AM) presents completely new options for you in terms
of implant design and surfaces!

How does it work?

Additive manufacturing is used to refer to a 3D printing process in the area
of generative manufacturing procedures. In a high pressure chamber, titanium
powder is transported into a working chamber using a scraper or roller. A laser
beam is reflected into the working chamber via a mirror and hits the titanium
powder there. The appearance of the laser beam causes the powder to melt
(this is why it is also called laser melting) and therefore compresses the material.
Once the laser has processed one working level, the working platform (table)
is lowered and a new layer of titanium powder is applied. This means that the
work piece is additively produced layer by layer. As the power density of the
laser is extremely high, highly-compressed three-dimensional work pieces are
produced.

8
What are the User‘s Advantages?
Dr. Dr. Jan-Dirk Raguse
The main advantages of additive manufacturing can Department of Oral and
essentially be summarized in the following qualities: Maxillofacial Surgery,
Charité – Universitätsmedizin
Berlin, CVK Campus
■ Quick: Additional tools and devices are no longer required
■ Varied: Free design of implants and their surfaces “The idea of an open, porous,
fine-mesh titanium net structure,
■ Osteoconductive: An open design of the implant body
which promotes osteoconductive
allows for the incorporation of the body‘s own cell structures incorporation of bone cells, has
■ Complex shapes are possible, such as honeycombs, grids, long fascinated us. In addition,
or porous structures this three-dimensional open
■ High-strength: The density, and therefore the strength, structure, unlike the otherwise
standard solid bodies, allows
of the material will be greater than a comparable work piece
for the option of charging the
made of pure titanium implant with autologous tissue
(e.g., cancellous bone).
With additively produced laser
implants, we have been able to
realize this vision in the current
form for the first time. It is
conceivable that there will be
many adjoining applications
in the future.“

9
 Materials: variety to match defects

Materials
that give you Choice

This detailed description of the individual materials and their

properties is designed to help you to choose your material.

PEEK

Additive Manufacturing Titanium PEEK – Polyether Ether Ketone

Brief description Completely free surfaces can be produced without tools PEEK is a high-strength, thermostable, high-performance
or devices. There are previously unprecedented options plastic. Thanks to its physical properties, which are compa-
for surface design. Reshaping processes are no longer rable to those of cortical bone in humans, PEEK is the type
required. of plastic most frequently used in orthopedics. The implants
are available completely solid or solid with holes.

Material Ti alloy Ti6Al4V Polyether ether ketone

Specified acc. to ASTM F136 -02a (ELI Grade 23) ISO 10993

Sterilization Steam sterilization at 134°C (273.2°F) Steam sterilization at 134°C (273.2°F)

EN 285 / ANSIA / AAMI / ISO 11134 – 1993 EN 285 / ANSIA / AAMI / ISO 11134 – 1993

Advantages ■ A wide selection of shapes, structures and styles is possible ■ Highly elastic, yet very strong and impact resistant
■ Precise fitting accuracy at the same time
■ High stability ■ Optimal protective function for patients
■ Osteoconductive structures are possible ■ No increase in thermal sensitivity
■ Complete design freedom for the material and its surface ■ Low weight
■ Quick ■ Resistant to gamma radiation and magnetic resonance
imaging (MRI)
■ Low artifact formation in X-rays
■ Three-dimensional bone replacement

Limitations ■ Any necessary revision surgery will only be possible ■ Only conditional cell apposition potential
with additional work ■ Intraoperative adjustment or cutting to size
■ Intraoperative cutting to length almost impossible is only possibly with additional effort
■ Requires further plates for fixation

10
 Individual Patient Solutions – which Base Material for which Purpose?

AM Titanium PEEK PEEK Titanium Mesh Solid Titanium

Subsequent implant correction ++ + ++ –
Mechanical strength +++ +++ ++ +++
Biocompatibility +++ +++ +++ ++
Thermal conductivity + +++ + –
Price level + + +++ ++
Potential for osseous integration +++ + +++ ++
Volume reconstruction +++ +++ + +++
Artifact likelihood ++ +++ ++ +

Titanium Mesh Solid Titanium

Brief description Unlike conventional osteosynthesis materials, titanium mesh Solid titanium represents a high-strength reconstruction
allows three-dimensional deep-drawing. A special thermal alternative to titanium mesh. Even though it has been
process ensures a closed microstructure. Therefore titanium widely superseded by titanium mesh in recent years,
mesh is stable and intact and offers very good biocompatibility it offers several advantages in specific fields of us –
as well as bone apposition potential. e.g., in relation to the mechanical protective function.

Material Pure titanium Pure titanium

Specified acc. to ISO 5832-2, ASTM F 67 ISO 5832-3, ASTM F 67

Sterilization Steam sterilization at 134°C (273.2°F) Steam sterilization at 134°C (273.2°F)

EN 285 / ANSIA / AAMI / ISO 11134 – 1993 EN 285 / ANSIA / AAMI / ISO 11134 – 1993

Advantages ■ Very good biocompatibility, potential for vascularization ■ High-strength reconstruction alternative
■ Favorable mechanical properties ■ Best mechanical protective function
■ Can easily be cut to size ■ No plates required for fixation
■ Bone cell apposition potential
■ Relatively low price level
■ No further plates required for fixation

Limitations ■ No three-dimensional bone substitute ■ Increased thermal conductivity

■ Need for tools ■ Subsequent bending not possible
■ Subsequent cutting to size not possible

11
 Indication: precisely-fitting implants for cranial defects

Indications
and Example Applications

Indications

■ Posttraumatic reconstructions
■ Loss of bone integrity
■ Cranial brain injuries with an increase in intracranial pressure
■ Reconstruction of defects caused by craniotomy
■ Tumors, ulcers, and cysts
■ Occurrences of infections or rejection reactions in the event of cranioplasty
■ Limited supply of autologous bone transplants

12
Step by Step
through your own Project

Patient-specific implants are complex projects, which demand mutual trust and
close coordination between all parties. The following chart shows the most important
considerations during the implementation of your own project at a glance:

1 Online inquiry In detail

■ Patient data (name, age, planned surgery date)
via IPS Gate®
■ Treating physician, if necessary additional contacts at the hospital

e.g., surgical staff, representatives

■ Are there material preferences?

■ Information on further treatment e.g., sketch of resection borders,

fastening type, and fastening points

IMPORTANT: The inquiry is non-binding for you. It is sent to
all relevant departments at KLS Martin at the same time.

We need your data in a compressed file – preferably in ”ZIP“ or ”RAR“

2 Data preparation
format. Please make sure that the compressed file to be sent to us contains
(by the user)
the complete data structure including all sub-directories (if applicable).

3 Ideally, directly upload the data into the IPS Gate® .

Data transmission

Can the data be used? No? You will be contacted immediately by KLS Martin.
Yes? You will be sent an offer and a proposal for implementation.

No? Please inform us of the progress of the project.

Has the offer been accepted?
In some cases, changes in design may result in price advantages.

Yes? Then please send us your order and the signed letter of approval.

4 Manufacturing Please allow approx. 5-10 working days for manufacturing.

5 Shipment Shipment is carried out unsterilized, including the relevant

anatomical model.

13
 Information: project process

Details on
Ordering and Project Handling

1Scan

2
Prepare
the Data

Achieving optimum Scanning Results Preparing the Data

■ Patient scans must be current and precise (< 4 months). To process your inquiry as swiftly as possible, we
■ The spatial resolution of the scans should range between suggest to upload your scanning data in a single
0.5 and 1.25 mm. In this case the interval must be no more compressed file — ideally in “ZIP” or “RAR” format.
than half the resolution of the individual planes. Please make sure that the compressed file to be sent
■ Orbital implants require a thin-layer CT scan with max. 1.00 mm to us contains the complete data structure including
spatial resolution. all sub-directories (if applicable).
■ It is essential to avoid patient movement during the scanning
process. If you do not have a suitable program, then you
■ Scans must be performed in an upright position. The image can easily download freeware for this purpose online,
plane must be at right angles to the plane of occlusion in order such as winzip, 7zip or IZarc.
to minimize artifacts.
■ The target area of the scan should be as small as possible,
but should include the region 2 cm above and below the
defect region.
■ The outer contours of the patient‘s head should also be
included.
Converting
■ Save the entire scan (incl. all sub-files) as a DICOM file. to a “ZIP” or
“RAR” file.

KLS Martin can process data from all commonly used CT

scanners and PCS systems, and can use almost all storage media.
Should you have any queries, please do not hesitate
to contact our hotline +49 7463 838-222.

14
 3 Data
Transfer
4Start

1. Sending or Uploading the CT Data Additional Information:

The fastest and easiest way is to send the data via our free- ■ We generally ship patient-specific implants with the corres-
of-charge online upload and communication platform IPS Gate® . ponding anatomical model.
The web-based platform and app guides surgeons and users ■ Anatomical models and patient-specific implants are delivered
reliably and efficiently through the process of inquiring about, non-sterile. Please observe the sterilization and cleaning
planning and completing patient-specific products. Thanks to instructions in the Instructions for Use supplied with the
the “HTTPS” standard, IPS Gate® ensures encrypted data trans- implant.
mission, which is additionally certified by the TÜV Süd seal. ■ Prior to initial use, patient-specific implants must be put
through the entire cleaning, disinfecting, and sterilization
[Link] process. Patient-specific implants are suitable for machine
processing and thermal disinfection.
For further information kindly see our FAQ under They can be processed with any program approved for
[Link] surgical instruments.

2. The following Information is important to us:

■ The data must be submitted by uploading it to IPS Gate®

■ Name of the patient
■ Name and hospital of treating physician
■ KLS Martin specialist partner
■ Patient-specific individual implant or anatomical model only
■ Additional order information and comments,
e.g., material preferred, thickness, points of anchorage
■ Scheduled date of surgery/delivery date for the patient-
specific implant

15
 Case examples: planning and practical implementation

Adjustment of various Defects

Secondary care for a maxillary defect Orbital floor fracture

Reconstruction following craniectomy Supraorbital defect

Revision of a mandible construction socket Secondary intervention on midface and eye

16
 Prof. Dr. Dr.
Nils-Claudius Gellrich
Additive Manufacturing Titanium Three-dimensional defect
Department of Cranio-
Osteoconductive structures to construction
maxillofacial Surgery,
restore the cheekbone/midface Hannover Medical School

“We combine several high-

tech procedures into one
process: exact diagnostics,
CAD-supported implant
design, and the latest manu-
facturing procedures from
additive manufacturing
technologies. The result is an
implant, which corresponds
precisely with our require-
ments and which can be
inserted without compli-
cations during surgery.“

Additive Manufacturing Titanium Additive Manufacturing Titanium

Precise coverage of an orbital floor Minimally invasive care for two orbital
defect without disruptive structures floor defects, including adjustment
to partial anatomical models

PD Dr. Dr. Majeed Rana

Department of Cranio-
maxillofacial Surgery,
University Medical Center
Düsseldorf

“The advantage of the

additive manufacturing
process is obviously that
we can now produce a pre-
cisely-fitting implant in one
piece, which corresponds
exactly to our pre-planning
with no sharp edges or
disruptive structures.
And all of this within a
realistic timeframe.”

17
 Case examples: planning and practical implementation

Additive Manufacturing Titanium

Extremely delicate initial situation:
The defect includes orbita, zygoma
and the maxillar region. By using
a 3-part implant, a patient-protective
access is guaranteed.

Additive Manufacturing Titanium

Extensive orbital floor defect
reconstructed by additive manu-
facturing

18
 Prof. Dr. Dr.
Additive Manufacturing Titanium The transplant is fixed in place using Carl-Peter Cornelius
Osteoconductive structures for individually produced plates. Department of Oral and
extensive reconstruction of the Maxillofacial Surgery,
midface and the maxilla LMU Munich

“For complex defects, we

no longer want to make do
with ready-made implants.
We define an exact workflow
and, as a result of this, an
implant which gives optimum
consideration to all of the
circumstances of the patient,
clinical picture, access, and
expected clinical result. The
fact that we are able to build
patient-specific implants is a
considerable advantage over
traditional methods for us.”

Additive Manufacturing Titanium Fixed-angle holes for optimum fixing

Three-dimensional shaped plate of a transplant with unconventional
to restore the resected lower jaw arrangement of the fixing points

19
 Visualization: an important detail for your surgical success!

Integrated Case Planning

Complex reconstruction cases traditionally involve a large number of unknown
factors. IPS Implants® uses considerable technical advances, brought about
in recent years by computerized preoperative case planning, and implements
the planning ideas into one entire package, which will withstand even critical
surgical situations. From the anatomical models, resectioning and positioning
templates, through to the implant which has been optimized specially for the
specific patient, the surgical team has all of the tools needed for targeted
implementation of their advance planning.

Prof. Dr. Dr. Max Heiland

Department of Oral and
Case Example
Maxillofacial Surgery,
Charité University Medical As an example, the case of a lower jaw reconstruction with a fibula transplant
Center Berlin (shown on the right) will be described here.

“Our hospital uses patient-

specific implants and case
planning, particularly in recon-
struction. Conventional tech-
niques often did not produce
the standard we expect for our
patients. Good case planning
anticipates both the donor
region and the receiving
region, and includes all
necessary templates. This
means that it is possible
to optimize both the design In a joint coordination process, the At the instruction of the treating
of the transplant and its
resection borders are first defined. physician, the defect needs to be
positioning in terms of the
patient‘s dental and aesthetic reconstructed with a fibular trans-
rehabilitation. We have come plant from the right fibula.
to know KLS Martin as a
reliable partner in this area.”

The donor region is virtually projec- ... is optimized to achieve the best
ted onto the receiver region, and the possible aesthetic and prosthetic
transplant... result.

20
As agreed, the right fibula is Anatomical considerations are
examined to find the point which respected and a resection template
allows for optimal compliance. is produced.

Finally, an implant optimized for In order to be able to carry out

the specific case is generated. the resection as planned, resection
templates are required which also
reflect the cutting angle.

The type, diameter, and length of the An overview of the entire service
osteosynthesis screws to be used are package.
also defined.

21
 Overview: Individual Patient Solutions

The IPS® Product Family

IPS CaseDesigner®

The IPS CaseDesigner® makes 3D virtual surgical planning

easier and faster than ever before. With this brand-new,
flexible software tool, planning and simulating surgical
interventions become efficient and reliable. Individualized
treatment concepts can be easily transferred through a Prof. Dr. Dr.
virtual approach towards patients in the operating theater. Gwen R.J. Swennen,
Bruges, Belgium
While the IPS CaseDesigner® software is covering multiple
“After 20 years of personal
sub-specialties of maxillofacial surgery, the first commer- experience with 3D virtual
cially available module is focusing on orthognathic surgery. planning, I think that with
It offers an intuitive and straightforward approach to IPS CaseDesigner® the next
virtual orthognathic planning by guiding the user through level of 3D virtual CMF
planning software has been
a step-by-step workflow.
reached. As a part of its
development I am sure it
will further improve patient
Recommended computer specifications care in the future.”

■ Broadband internet connection

■ Windows 10, 64 bit or Mac OS X Yosemite or higher
■ Good graphics card (NVIDIA, AMD) 3D Virtual Treatment Planning
■ HD screen resolution of Orthognathic Surgery.
■ Min. 8 GB RAM A Step-by-Step Approach for
Orthodontists and Surgeons.
Springer.

22
IPS Gate® IPS Implants®

The web-based platform and app Patient-specific implants, planning

guides surgeons and users reliably aids, and anatomical models are
and efficiently through the process made from various materials using
of inquiring about, planning, and state-of-the-art fabrication techno-
completing patient-specific products. logies. Thanks to computer-based
With the HTTPS standard IPS Gate® planning and functionalized patient-
guarantees encrypted data trans- specific implants, preoperative
mission, which is additionally planning can be implemented in
certified by the TÜV Süd seal. surgery with unprecedented pre-
cision.

23
KLS Martin Group

KLS Martin Australia Pty Ltd. KLS Martin do Brasil Ltda. KLS Martin Medical (Shanghai) KLS Martin India Pvt Ltd.
Sydney · Australia São Paulo · Brazil International Trading Co. Ltd. Chennai · India
Tel. +61 2 9439 5316 Tel. +55 11 3554 2299 Shanghai · China Tel. +91 44 66 442 300
australia@[Link] brazil@[Link] Tel. +86 21 5820 6251 india@[Link]
china@[Link]

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Milan · Italy Tokyo · Japan Penang · Malaysia Mexico City · Mexico
Tel. +39 039 605 67 31 Tel. +81 3 3814 1431 Tel. +604 505 7838 mexico@[Link]
italia@[Link] nippon@[Link] malaysia@[Link]

Martin Nederland/Marned B.V. Gebrüder Martin GmbH & Co. KG KLS Martin Taiwan Ltd. Gebrüder Martin GmbH & Co. KG
Huizen · The Netherlands Moscow · Russia Taipei 106 · Taiwan Dubai · United Arab Emirates
Tel. +31 35 523 45 38 Tel. +7 499 792-76-19 Tel. +886 2 2325 3169 Tel. +971 4 454 16 55
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KLS Martin UK Ltd. KLS Martin LP

London · United Kingdom Jacksonville · Florida, USA
Tel. +44 1189 000 570 Tel. +1 904 641 77 46
uk@[Link] usa@[Link]

Gebrüder Martin GmbH & Co. KG

A company of the KLS Martin Group
KLS Martin Platz 1 · 78532 Tuttlingen · Germany
P.O. Box 60 · 78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@[Link] · [Link]

90-242-02-10 · Rev. 01 · 2019-11 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten · Technische Änderungen vorbehalten
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