INFORMATION ON THE PRODUCT RANGE. Midface MODUS

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1 INFORMATION ON THE PRODUCT RANGE Midface MODUS

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3 MODUS Midface INTRODUCTION The midface consists of a complex structure with differently shaped bone parts. The structure varies in thickness, with particular stability along the midface columns. The more delicate areas are at increased risk of fracture when subjected to force. Particular care is therefore recommended depending on the indication (orthognathic repositioning or treatment of midface trauma). For successful midface osteosynthesis, indication-specific plates and screws with outstanding cutting properties are required. Because there are a limited number of suitable approaches, ergonomic instruments and implants which are easy to handle are indispensable. With the MODUS midface systems, Medartis offers a broad range of solutions for trauma, reconstructive surgery, and orthognathic procedures. This permits the surgeon to choose from a large selection of flexible or rigid plates and different plate heights. Each system also offers anatomically formed plates to ensure optimal results. Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis AG, 4057 Basel, Switzerland.

4 4 MODUS Midface Precision in fixation D image of a TriLock screw 2 Medartis headquarters in Basel 3 Screw production 4 TriLock demo model, scale 10:1 5 Quality inspection

5 MODUS Midface 5 Medartis AG, headquartered in Basel, Switzerland, specializes in technical high-precision implants for surgical fixation of bone fractures and osteotomies. Medartis develops, manufactures and sells titanium screws and plates, surgical instruments and system solutions for fracture fixation. These implants allow for patient rehabilitation after surgical reconstruction of fractures, malunions and deformities or skeletal diseases and their adjacent soft tissues. Medartis is represented worldwide through its subsidiaries and a broad distributor network. Our motto is Precision in fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for surgeons, OR staff and patients. This enhances long-term customer relations based on partnerships and has formed the foundation for sustainable success since the company s founding in The goal of Medartis is to continually improve early functional rehabilitation through its high-quality products and exclusively developed technologies. In order to fulfill the growing requirements of medical devices, our development teams engage in intensive knowledge exchange with our customers, partners and leading scientific institutes globally. Medartis international locations allow us to determine the needs of surgeons and patients directly on site and to incorporate these needs into product development. This is the only way we can efficiently resolve current clinical problems and offer market-oriented products for use in the OR. Service quality is considerably shaped by our international presence as well as local cooperation. Product quality is maintained by the fact that the entire process chain from development to aftercare is in the hands of our internal departments. Medartis can thus exclusively apply the newest technologies during product development for special areas such as small-bone surgery. At the same time, we have the greatest possible control over process quality and flexibility.

6 6 MODUS Midface Systems for a variety of indications MODUS Midface For indication-specific trauma treatment For orthognathic procedures due to dental or mandibular malalignment For reconstruction after tumor resection 1 2 3

7 MODUS Midface 7 MODUS MIDFACE Trauma Trauma surgery (oral and maxillofacial surgery) is performed to treat what is in most cases accidental injury to the craniofacial bones and soft tissues. In trauma patients, the fracture lines pass across all of the midface bones and are usually defined by the supporting columns and/or by skeletal points of weakness. The goal of surgical intervention is to ensure secure fixation of these fractures and to reconstruct the soft tissue defects as precisely as possible in order to restore the patient's appearance to its natural pre-trauma state. Orthognathic surgery Orthognathic surgery covers the surgical treatment of abnormalities of the jaw for which orthodontic mandibular adjustment is insufficient. Malpositioning needs to be corrected when functional problems such as impaired chewing function or even long-term temporomandibular joint problems resulting from constant excess stress have already occurred or are expected to develop. Reconstruction Plastic reconstructive surgery plays an important role in restoring the bone structures of the midface after tumor removal or in patients with major bone defects resulting from trauma, due to the fact that this type of surgery has a direct impact on aesthetic appearance and function. The goal is to restore the previous form and function in order to allow the patients to be reintegrated into their social environment. The MODUS systems offered by Medartis stand out due to an innovative range of plates and screws in various dimensions, anatomical forms and geometries. Selecting the right implant depends on the thickness, quality, and shape of the bone structure Zygomatic arch fracture - MODUS Orbital floor fracture - MODUS OPS Intermaxillary fixation - MODUS IMF Centrolateral midface fracture - MODUS Frontozygomatic fracture of the lateral orbital rim - MODUS 1.5

8 8 MODUS Midface Anatomically pre-contoured plate design MODUS Midface Fixation plates in the module 2 Detail of an orbital floor plate 3 Detail of mesh implants 4 Part of a skull bone model 5 Finite elements presentation of a Medartis plate For further information on the plate range, see the MODUS Ordering Catalog at

9 MODUS Midface 9 Indication-specific plates Range of rigid and semi-rigid plates Plate profiles optimized for stability PLATE RANGE The midface plate range includes a large selection of plates and mesh for the following indications and procedures: Maxillary and zygomatic fractures, fractures to the bridge of the nose, and LeFort I, II, and III fractures Treatment of orbital fractures Orthognathic maxillary procedures (LeFort I, II, and III) Midface reconstruction after tumor resection PLATE FEATURES Anatomically pre-contoured plate geometries for simple intraoperative application Indication-specific plates in the orbital, zygomatic and LeFort I regions Low profile and optimally matched screw/plate profile to maximize soft-tissue protection Color-coded implants for an easy identification in the OR: o o Gold = Rigid cranial plates Green / blue = Malleable cranial, grid, or orbital floor plates Different distances between screw holes in each plate thickness for indication-specific fixation Ø 1.2 Ø mm 0.6/0.7 mm Two screw sizes can be used for each plate thickness: o 0.9/1.2 screws for 0.5 mm plates o 1.5/1.8 screws for 0.6/0.7 mm plates o 2.0/2.3 screws for 0.8/1.0 mm plates Ø 1.8 Ø 1.5 Ø /1.0 mm Ø 2.0 Ø 2.0 Ø 2.3

10 10 MODUS Midface Superior screw technology MODUS Midface SpeedTip polygonal cutting tip 2 Sharp screw thread 3 Finite elements presentation of a HexaDrive screw head For further information on the screw range, see the MODUS Ordering Catalog at

11 MODUS Midface 11 Outstanding thread characteristics HexaDrive interface with excellent self-holding properties SpeedTip thread design for time saving and effortless insertion SCREW OPTIONS Selection between HexaDrive or cross-drive screws 0.9/1.2/1.5/1.8/2.0/2.3 mm self-tapping cortical screws 1.5/2.0 SpeedTip screws (self-drilling) Screw lengths from 2 mm to 23 mm 2.0 mm self-drilling IMF screws Cortical screws self-tapping IMF screws self-drilling SpeedTip screws self-drilling SCREW FEATURES HexaDrive technology the optimal self-holding mechanism between screw and screwdriver for increased torque transmission Excellent self-holding properties Outstanding self-tapping characteristics and easy screw insertion thanks to a precise and sharp thread SpeedTip technology for self-drilling screws: o o o Reduced risk of dislocation thanks to excellent grip Effortless insertion: Only the polygonal tip pushes bone material aside regardless of screw length Excellent tactile feedback during insertion Contact surface for screw retention Contact surface for torque transmission Screws can be inserted more rapidly due to a thread pitch which is optimized for the length of the screw Enlarged screw core diameter at the end of the thread for increased shear strength

12 12 MODUS Midface Technology, materials and biomechanics MODUS Midface MODUS mesh structure 2 Biomechanical testing on an implant 3 Finite elements presentation of an orbital floor plate

13 MODUS Midface 13 SpeedTip thread design - direct implantation without pre-drilling High-quality materials Highest quality standard SPEEDTIP THREAD TECHNOLOGY The unique function and rapid-grip tip design allows for immediate gripping of the bone with only a slight axial pressure. The triangular shaft design permits simultaneous drilling and displacement of the bone material in the zone behind the screw cutting tip. The tapered shaft beneath the polygonal tip also helps to reduce the insertion torque, as well as giving the surgeon tactile feedback of the bone layer in which the screw is currently located (e.g. penetration of the cortex). ANATOMIC DESIGNS Complex fractures or adjustments require sophisticated products to ensure a perfect outcome. Therefore, Medartis pays attention to anatomic shapes and products which are easy to implant. Smooth surfaces and rounded edges have a lower risk of triggering soft tissue irritation, which ultimately results in a positive outcome for both the user and the patient. MATERIALS Plates and screws are made from pure titanium (ASTM F67, ISO ) or from titanium alloy (ASTM F136, ISO ). Titanium is a safe and reliable material, which is biocompatible and corrosion-resistant, does not trigger any allergic reactions and, according to current understanding, can remain in the body indefinitely. BIOMECHANICS Computer-optimized plate geometries ensure that the implants can withstand high mechanical stress with minimal plate thickness.

14 14 MODUS Midface Instruments MODUS Midface Plate bending pliers 2 Plate cutting pliers 3 Self-holding mechanism screw/screwdriver 4 Color-coded instruments in the instrument tray 5 Measurement unit of the depth gauge

15 MODUS Midface 15 Reduced instrument kit Intuitive application due to clear color coding Easy to use SIMPLE INSTRUMENT KIT The Medartis instruments are compact, ergonomically designed and easy to use. Depth gauge for single-handed use One screwdriver and one plate holding and positioning instrument for each system size (0.9/1.2, 1.5 and 2.0) One drill guide for all drill diameters in each system size One plate bending pliers for all plate sizes Patented Vario cutting pliers for round cutting for all system sizes CLEAR COLOR CODING CONCEPT Twist drills and instruments have a consistent and clear color code which allows for intuitive use within the different system sizes. MODUS 0.9/ 1.2 = red MODUS 1.5 MODUS 2.0 MODUS Mesh = green = blue = yellow

16 16 MODUS Midface Storage in Perfection MODUS Midface Plate module 2 Instrument tray 3 Bottom view: implant container 4 Drill module 5 Implant container with color coding

17 MODUS Midface 17 Modular, economic, compact Combinable sets Clear and consistent color coding COMPACT SETS The MODUS sets for the midface consist of an implant container and an instrument tray. These can be stored together in a specifically marked sterilization container. The compact design also saves space when the instrumentation is set out on the instrument table. MODULAR DESIGN Depending on user requirements, up to four different implant containers can be combined in one rack. Each individual system size will use the same instruments. CONSISTENT COLOR CODING AND LABELING CONCEPT All of the containers are coded with a color bar depending on the system size. The individual plate fields and screw lengths are labeled to permit clear identification of plates and screws.

18 18 MODUS Midface Clinical Examples MODUS Midface Case 1 - Midface frontal fracture Preoperative x-ray Intraoperative view Treatment of a frontal fracture and reconstruction of the orbital roof with MODUS mesh and MODUS 1.5 implants Postoperative x-ray Case 2 - Corrective osteotomy - LeFort I Preoperative x-ray Fixation of the mobilized maxilla with MODUS 1.5 and MODUS 2.0 implants Postoperative x-ray - frontal projection Case 3 - Zygomatic arch fracture Preoperative view Treatment of fracture with MODUS 1.5 straight plates Postoperative CT With kind permission of: Münster University Hospital, Germany, Inselspital Berne, Switzerland, Feldkirch State Hospital, Austria, Faculdade de Odontologia de Araraquara (Unesp), Brazil

19 MODUS Midface 19 Case 4 - Frontal bone fracture Preoperative 3D-CT Intraoperative view - cranioplasty with MODUS 1.5 implants Intraoperative 3D-CT Case 5 - Fracture of the left orbital floor Preoperative CT - frontal projection Intraoperative view - treatment of a fracture with a MODUS OPS 1.5 implant Postoperative CT - frontal Case 6 - Extensive relapsed tumor with orbital penetration Preoperative CT Reconstruction of the cheek contour with a MODUS Trauma 2.0 grid plate Postoperative x-ray with titanium mesh and grid plate

20 MIDFACE _v0 / , Medartis AG, Switzerland. All technical data subject to alteration. HEADQUARTERS Medartis AG Hochbergerstrasse 60E 4057 Basel/Switzerland P F SUBSIDIARIES Australia Austria France Germany Mexico New Zealand Poland UK USA For detailed information regarding our subsidiaries and distributors, please visit

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