Medartis MODUS 2 User manual

MODUS®
SURGICAL TECHNIQUE – STEP BY STEP
MODUS®2
Intermaxillary
Fixation System IMF

2 | Intermaxillary Fixation System IMF
www.medartis.com
Contents
3 Introduction
3 Product Materials
3 Indications
3 Contraindications
3 Color Coding
3 Symbols
4 System Overview
5 Treatment Options
6 Instrument Application
6 General Instrument Application
6 Picking up the Titanium Arch Bar
6 Cutting the Titanium Arch Bar
6 Bending the Titanium Arch Bar
7 Drilling
7 Screw Pick-Up
8 Explantation of MODUS 2 IMF Implants
9 Surgical Technique
9 IMF Screws Application
9 Determining the Screw Position
10 Inserting the Screws
11 Intermaxillary Fixation with Ligature Wires
11 Intermaxillary Fixation with Elastomeric Wires
12 MODUS 2 IMF Titanium Arch Bar Application
12 Adapting the Titanium Arch Bar to the Maxilla
14 Adapting the Titanium Arch Bar to the Mandible
15 Appendix
15 Implants and Instruments
For further information regarding the MODUS product line visit www.medartis.com
Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG / Medartis Holding AG, 4057 Basel, Switzerland

Intermaxillary Fixation System IMF | 3
www.medartis.com
Introduction
All MODUS 2 implants are made of pure titanium (ASTM
F67, ISO 5832-2) or titanium alloy (ASTM F136,
ISO 5832-3). All of the titanium materials used are
biocompatible, corrosion-resistant and non-toxic in a
biological environment.
The instruments are made of stainless steel, PEEK,
aluminum or titanium.
Indications
MODUS 2 IMF is indicated for temporary perioperative
xation and / or stabilization of occlusion.
Contraindications
• Pre-existing or suspected infection at or near the
implantation site
• Known allergies and /or hypersensitivity to implant
materials
• Inferior or insufcient bone quality to securely anchor the
implant
• Patients who are incapacitated and /or uncooperative
during the treatment phase
• Blocking of cranial sutures /growth plates with plates and
screws
• Not intended for use in direct contact with the dura mater
and the central nervous system
• The IMF screws cannot be used in unstable fractures
Screw Diameter Color Code
2.0 Blue
Plates and Screws
Implant plates gold Fixation plates, rigid
Implant screws green SpeedTip screws
(self-drilling)
Symbols
HexaDrive
Product Materials Color Coding
See Instructions for Use
www.medartis.com

4 | Intermaxillary Fixation System IMF
www.medartis.com
System Overview
MODUS 2 IMF is available in the following designs.
Description Examples
2.0 IMF SpeedTip
Screws without
Plateau
M2-5248.08 M2-5248.11 M2-5248.14
2.0 IMF SpeedTip
Screws with Plateau
M2-5249.08 M2-5249.11
Titanium Arch Bar
M-4450

Intermaxillary Fixation System IMF | 5
www.medartis.com
Treatment Options
The table below lists typical clinical ndings which can be treated with the MODUS 2 IMF.
The above-mentioned information is a recommendation only. The operating surgeon is solely responsible for the choice of the suitable implant for
the specific case.
Description Examples
Perioperative xation of the
occlusion during orthognathic
or orthodontic surgery with IMF
screws
Perioperative xation of the
occlusion during orthognathic or
orthodontic surgery with titanium
arch bars
Immobilization of a fractured jaw
(immediate measure)
2.0 IMF
SpeedTip
Screws
M2-5248.08 M-4450 M2-5248.08
M2-5248.11 M2-5248.11
M2-5248.14 M2-5248.14
M2-5249.08 M2-5249.08
M2-5249.11 M2-5249.11

6 | Intermaxillary Fixation System IMF
www.medartis.com
Instrument Application
General Instrument Application
Picking up the Titanium Arch Bar
For the removal of the titanium arch bar (M-4450), the use
of conventional anatomical forceps is recommended.
Grasp the arch bar as close as possible to the medial pin and
extract it vertically from the container.
Cutting the Titanium Arch Bar
A conventional wire cutter (e. g. Aesculap – DP560R) can be
used to cut the arch bar.
Visually check the desired cutting line before cutting. Ensure
that enough material is left on the arch bar to keep the
adjacent pin intact.
Bending the Titanium Arch Bar
The titanium arch bar can be bent by hand to adapt it to the
dental arch.
Caution
Repeatedly bending the titanium arch bar in opposite
directions may cause the arch bar to break.

Intermaxillary Fixation System IMF | 7
www.medartis.com
Drilling
With very hard bone it may still be necessary to pre-drill
despite the use of self-drilling SpeedTip IMF screws.
A color-coded twist drill is available for MODUS 2 IMF
screws. It is color coded with a ring.
Screw Diameter Color Code
2.0 Blue
Drills for SpeedTip IMF screws 2.0 (drill 1.5)
Dental Stryker
M2-3159 M2-3169 25 mm
Caution
It is recommended not to exceed the maximum speed of
1’000 revolutions per minute. Higher speeds can lead to
over-heating of the bone.
Screw Pick-Up
The screwdriver handle M2-2001 is compatible with the
screwdriver blade M2-2005. The screwdriver blade features
the patentend HexaDrive self-holding system.
M2-2001
Screwdriver Handle, Type 2
M2-2005
Screwdriver Blade, HD6, 95 mm
M2-3159

8 | Intermaxillary Fixation System IMF
www.medartis.com
Check the screw length at the corresponding length
measuring module of the container: the screw length is
determined at the tip of the screw.
Notice
Different length measuring modules are available for the IMF
screws M2-5248.xx and M2-5249.xx. Ensure that the screws
are checked at the corresponding length measuring module.
Explantation of MODUS 2
IMF Implants
For the explantation of MODUS 2 IMF screws, use the
appropriate screwdrivers.
For removal of the MODUS 2 titanium arch bar, conventional
wire cutters and forceps can be used.
Notice
Only original MODUS 2 instruments are recommended for
the explantation of MODUS 2 IMF screws.
Notice
The screw will not hold without axial pressure!
Vertically extract the screw from the compartment.
Notice
Picking up the screw repeatedly may lead to permanent
deformation of the self-retaining area of the HexaDrive inside
the screw head. Therefore, the screw may no longer be able
to be picked up correctly. In this case, a new screw has to be
used.
To remove the screws from the implant container, insert the
appropriately color-coded screwdriver blade perpendicularly
into the screw head of the desired screw and pick up the
screw with axial pressure.

Intermaxillary Fixation System IMF | 9
www.medartis.com
Surgical Technique
IMF Screws Application
Information on the application of the MODUS 2 IMF screws.
M2-5248.08 2.0 IMF SpeedTip screw, without plateau, 8 mm
M2-5248.11 2.0 IMF SpeedTip screw, without plateau, 11 mm
M2-5248.14 2.0 IMF SpeedTip screw, without plateau, 14 mm
M2-5249.08 2.0 IMF SpeedTip screw, with plateau, 8 mm
M2-5249.11 2.0 IMF SpeedTip screw, with plateau, 11 mm
Determining the Screw Position
Screw placement sites are selected considering anatomical
structures (i. e. root apices, neurovascular bundles or nasal
mucosa) and fracture positions.
In the maxilla, the screws are placed above or between the
root apices.
In the mandible, the screws are placed below or between the
root apices.
Caution
When inserting the screws, attention must be paid to the
course of the inferior alveolar nerve.
Notice
For an intermaxillary xation, a minimum of two screws in
the maxilla and two screws in the mandible is recommended.
Caution
Do not insert MODUS 2 IMF into root apices. This can lead
to an injury of the root apices and /or breakage of the screw.

10 | Intermaxillary Fixation System IMF
www.medartis.com
Inserting the Screws
All MODUS 2 IMF screws feature a self-drilling thread, which in
most cases makes pre-drilling unnecessary.
Insert the rst screw in the desired position.
Insert the remaining screws.
Notice
An unexpected increase of the tightening torque in cortical
bone can occur when using MODUS 2 IMF screws. If so,
remove the MODUS 2 IMF screw and drill a hole using the twist
drill (see section "Drilling").

Intermaxillary Fixation System IMF | 11
www.medartis.com
Intermaxillary Fixation with Elastomeric
Ligatures
Place the elastomeric ligatures into the grooves of the screw
heads in the maxilla and mandible.
Intermaxillary Fixation with Ligature
Wires
Thread the ligature wire (maximum diameter 0.7 mm) through
the through bore of the screw. For easy orientation, the through
bores are placed parallel to the markings on top of the screw
head.
Alternatively, the ligature wire can be wrapped around the
grooves in the screw head.
Fix the ligature wire using any forceps. Bend the wire ends into
an atraumatic position and cut them.

12 | Intermaxillary Fixation System IMF
www.medartis.com
Adapting the Titanium Arch Bar to the
Maxilla
Bending of the medial pin for easier positioning of the arch bar.
Information on the application of the MODUS 2 IMF
titanium arch bar.
MODUS 2 IMF Titanium Arch Bar Application
M-4450S
Titanium Arch Bar, 129 mm, 2/Pkg
Shorten the arch (see section “Cutting the Titanium Arch
Bar”).
Adapt the arch bar to the dental arch (see section “Bending the
Titanium Arch Bar”).
Notice
The medial pin should be placed between the two incisors on
the sagittal plane.

Intermaxillary Fixation System IMF | 13
www.medartis.com
Fix the arch bar with three ligature wires per quadrant.
Shorten the ligature wires.
Notice
For shortening of the ligature wires any wire cutter can be
used.
Tighten and bend the ligature wires.

14 | Intermaxillary Fixation System IMF
www.medartis.com
Adapting the Titanium Arch Bar to the
Mandible
Curved pre-bending of the arch bar to imitate the Spee curve
of the mandible.
Align the arch bar to the mandibular teeth.
The next steps are analogical to the adaptation of the arch
bar to the maxilla.
Intermaxillary xation with elastomeric ligatures or ligature
wires.
Notice
If individual pins have contact with the mucosa, the pins
concerned must be bent away slightly in order to prevent soft
tissue irritation.
The length of the pins allows for the use of 2–3 elastomeric
ligatures per pin.
Cut off the medial pin.

Intermaxillary Fixation System IMF | 15
www.medartis.com
Appendix
Implants and Instruments
For detailed ordering information, please refer to the MODUS 2 IMF Product Information, also available at www.medartis.com.
Screws
Art. No.
M2-5248.08
M2-5248.08S
M2-524 8.11
M2-524 8.11S
M2-5248.14
M2-5248.14S
M2-5249.08
M2-5249.08S
M2-5249.11
M2-5249.11S
Art. No.
M-4450
M-4450S
Instruments
Art. No.
M2-2001
M2-2005
RCI
Art. No.
M2-3159
M2-3159S
M2-3169
M2-3169S
Titanium Arch Bar

MANDIBLE2-01020001_v0 / © 2020-02, Medartis AG, Switzerland. All technical data subject to alteration.
MANUFACTURER & HEADQUARTERS
Medartis AG |Hochbergerstrasse 60E |4057 Basel / Switzerland
P [phone] |F [phone] |www.medartis.com
SUBSIDIARIES
Australia |Austria
|Brazil |France |Germany |Japan |Mexico |New Zealand |Poland |UK |USA
For detailed information regarding our subsidiaries and distributors, please visit www.medartis.com
Disclaimer: This information is intended to demonstrate the Medartis portfolio of medical devices. A surgeon must always rely on her or his own professional clinical
judgement when deciding whether to use a particular product when treating a particular patient. Medartis is not giving any medical advice. The devices may not be
available in all countries due to registration and / or medical practices. For further questions, please contact your Medartis representative (www.medartis.com). This
information contains CE-marked products.
For US only: Federal law restricts this device to sale by or on the order of a physician.