Osteosynthesis. Reference Guide for Upper-Face Mid-Face Orthognathics Mandible Fracture and Reconstruction

Transcription

1 Osteosynthesis Reference Guide for Upper-Face Mid-Face Orthognathics Mandible Fracture and Reconstruction

2 Legend The color coding of the screw diameter 1.2 mm Screw Diameter 1.7 mm Screw Diameter 2.0 mm MP Screw Diameter 2.0 mm Screw Diameter 2.3 mm Screw Diameter The color coding of the screw types Bone Screws, Cross Pin, Self Tapping Bone Screws, Cross Pin, Self Tapping, MP Bone Screws, Cross Pin, Self Tapping Emergency Bone Screws, Cross Pin, Self Drilling Bone Screws, Cross Pin, Locking The measurement of the screws 1.7 x 6 mm screw 6.0 mm 1.7 mm Screw length definition refers to the length of the thread only The plates All plates are depicted in actual size Order Numbers Order No. Non- Product (black) Order No. Product (grey) Universal Features smartlock Locking Screw Technology for angled screw insertion Graduated Stability Plates, 100 L-Plates increasing stability depending on plate length Self-Drilling Self-Tapping Locking Screw Options Self Drilling, Self Tapping and Locking Screws Malleable Plates - low profile (blue)

3 Table of Contents Leibinger Universal 2 Leibinger Universal 2 Leibinger Universal A Universal Concept For Craniomaxillofacial Surgery... 4 Universal Features... 4 The Leibinger Universal 2 Implant Modules... 6 The Leibinger Universal 2 Color System... 9 Modules 1.2 mm Upper-Face Fixation Module Bone Screws Plates Drill Bits Instrument Set mm Mid-Face Fixation Module Bone Screws Plates Drill Bits Instrument Set MP Mini Plating Module Bone Screws Plates Drill Bits Instruments / 2.0 / 2.3 mm Orthognathic Fixation Module mm Bone Screws mm Orthognathic Plates / 2.3 mm Mandibular Bone Screws / 2.3 mm Orthognathic Plates Drill Bits Instrument Set / 2.3 mm Mandible Fracture Module Bone Screws Plates Other Instruments Instrument Set / 2.3 mm Mandible Reconstruction Module Bone Screws Indications Reconstruction Plates Plates Other Instruments Drill Bits Instrument Set mm Lag Screw Module mm MMF Self-Drilling Module Other Sterilization, Organization Storage Screw length markers Numerical Index Order Numbers / 2.3 mm Mandible Fixation Module Bone Screws Plates Other Instruments Drill Bits Instrument Set

4 Leibinger Universal 2 A Universal Concept For Craniomaxillofacial Surgery The Leibinger Universal 2 CMF System represents the next generation of bone fixation for all Cranio-Maxillofacial fractures, orthognathic and reconstructive needs. Within the Universal 2 Fixation System surgeons have the choice between a wide variety of high-quality modules covering every known major indication in Cranio-Maxillofacial surgery. Due to its modular concept the balance between a comprehensive offering traditionally requiring large and complex systems and a solution for specific indications only, often compromising the options at hand, can more easily be achieved. All the modules of the Leibinger Universal 2 Fixation System, however, share the same underlying Leibinger principle: precision engineering and high quality standards in their manufacturing process. Universal Features Poly-Axial Locking Screw Technology The only one-step locking screw with a locking capability up to 10 of angulation for Mid-Face and Mandible locking plates. The smartlock poly-axial Locking Screw Technology* in Mid-Face and Mandible applications not only provides a more stable plate-screw construct, but also decreases the possibility of infections or implant failure caused when screws loosen. * The SmartLock Locking Technology is patent-protected in the US and Germany (US 6,322,562; DE ) by Prof. Dietmar Wolter, Hamburg, Germany. Smarter Implant Design smartlock Technology accommodates fixation of plates with multiple screw designs, i.e. self-drilling, self-tapping or locking screws Self-Drilling Self-Tapping Locking 1.7mm Locking Implants for Mid-Face A stronger 0.8 mm plate profile which is ideal for Le Fort I orthognathics and trauma applications allows for a 40% higher stability in comparison to regular 1.7 mm implants* * Flinzberg S., et al., Osteosynthetische Versorgung von Mittelgesichtsfrakturen mit einem multidirektionalen winkelstabilen Plattensystem: Biomechanische Ergebnisse (Osteosynthesis of Mid-Face Fractures with a Polyaxial Locking Plating System: Biomechanical Results), Mund Kiefer Gesichtschirurgie 2004, 8: mm 0.8 mm 4

5 Malleable Easy-to-contour Plates These easy-to-contour Malleable Low Profile Plates are the ideal implants for the management of small bone fragments in non-load bearing regions of the skull. The malleable design enables the plates to be bent on contact with the finger tips in situ. GSP Graduated Stability Plates The Graduated Stability Plates offer the progressive level of fixation required as the advancement increases. This built-in progressive stability is a unique feature that allows for optimal fixation The shorter plates used for limited advancements are more malleable for ease of use The longer plates used for extensive advancements provide the increased level of rigidity required for stable fixation Universal Cross Pin Screw Head Design All neutral, self-drilling, locking and lag screws have the Cross Pin head design which combines the advantages of Outstanding friction fit Improved axial guidance Excellent torque transmission SmartLoad Screw Delivery Fields The screw field design features a recessed screw hole that facilitates easy loading of the screw by guiding the tip of the screwdriver blade accurately into the head of the screw Customizable screw length and screw type markers allow for optimized storage of popular screw sizes and designs Implants The requirements on traceability throughout the value chain from manufacturer to hospital and patient are met by the sterile offering of the Leibinger Universal 2 Fixation System Double blister packaging enable sterile delivery into the operative field Each package contains four self-adhesive patient record labels to be used for the patient s file Grey item numbers within the product descriptions of this catalog reference sterile products 5

6 Leibinger Universal 2 The Leibinger Universal 2 Implant Modules The Leibinger Universal 2 System represents the next generation of bone fixation for all Cranio-Maxillofacial fractures, orthognathic and reconstructive needs. 1.2 mm Upper-Face Fixation Module Indications Trauma Cranial vault fractures Orbital rim fractures Frontal sinus fractures Naso-orbital-ethmoidal fractures Reconstruction of bony defects and deformities Cranial vault Bone graft fixation Orbital region Zygomatic region Dento-alveolar region Unique Features Malleable Low Profile plates (blue) for Micro applications, easy to adapt to the bony structure with the finger tips Standard plates (gold) offer slightly more stability Choice of 1.2 mm self-drilling and self-tapping screws 1.7 mm Mid-Face Fixation Module Indications Trauma Le Fort I, II, III fractures Zygomatic fractures Naso-orbital-ethmoidal fractures Cranial vault trauma Reconstruction of bony defects and deformities Le Fort I, II, III levels Maxilla Orbital region Zygomatic complex Cranial vault Unique Features Comprehensive selection of Malleable (blue) and Standard (gold) plates GSP plates offer a combination of malleable, standard and rigid plates Mid-Face locking plates (grey) that accommodate all 1.7 mm screws Choice of 1.7 mm self-drilling, selftapping and locking screws Universal screwdriver for all 1.7 mm and 1.2 mm screws 2.0 mm MP Mini Plating Module Indications Craniofacial fractures Orthognathics Midface/Mandible Genioplasty fixation Sagittal split osteotomy fixation Unique Features Comprehensive selection of Würzburg and Steinhäuser type plates Choice of 2.0 mm MP self-drilling and self-tapping screws Implant module is available in both full and half sizes Optimized thread pitch on 4 and 5 mm screws 6

7 1.7/2.0/2.3 mm Orthognathic Fixation Module Indications 1.7 mm Indications Le Fort I, II, III osteotomy fixation Genioplasty fixation Dento-alveolar osteotomy fixation Bone graft fixation 2.0/2.3 mm Indications Sagittal split osteotomy fixation Unique Features 1.7 mm Four easy to identify L-plate types: Standard (gold), Malleable (blue), GSP (gold, marked G ) and Locking (grey) Pre-bent maxillary advancement plates Choice of 1.7 mm self-drilling, self-tapping and locking screws Unique Features 2.0/2.3 mm Sagittal split osteotomy plates to be used with locking or neutral screws Dedicated orthognathic trocar system 2.0/2.3 mm Mandible Fixation Module Indications 2.0 mm Mini Plate Indications Mandibular fracture osteosynthesis Sagittal split osteotomy fixation 2.0/2.3 mm Fracture Plate Indications Simple, multiple, oblique and comminuted fractures of: - Symphysis and parasymphysis - Mandibular body - Mandibular angle Unique Features Half size module for low profile Mini and 3-D plates (blue) as well as Fracture and Compression plates (gold) All plates are compatible with the multidirectional locking and neutral screws Universal screwdriver for 2.0 and 2.3 mm screws 2.0/2.3 mm Mandible Fracture Module Indications 2.0 mm Mini Plate Indications Mandibular fracture osteosynthesis Sagittal split osteotomy fixation 2.0/2.3 mm Fracture Plate Indications Simple, multiple, oblique and comminuted fractures of: - Symphysis and parasymphysis - Mandibular body - Mandibular angle Unique Features Full size module for low profile Mini and 3-D plates (blue) as well as Fracture and Compression plates (gold) Fracture plates (gold) have laser etchings across top of the plate to aid in top/bottom orientation All plates are compatible with the multidirectional locking and neutral screws Universal screwdriver for 2.0 and 2.3 mm screws MMF self-drilling screws available 7

8 Leibinger Universal 2 The Leibinger Universal 2 Implant Modules 2.0/2.3 mm Mandibular Reconstruction Module Indications Primary Recon Plate Indications Fixation of microvascular grafts in a single step reconstruction after resection Comminuted mandibular fracture fixation Reconstruction Plate Indications Continuity defect bridging after resection of a tumor, osteomyelitis or osteoradionecrosis and the fixation of microvascular or nonvascularised grafts in a primary reconstruction Continuity defect bridging prior to secondary reconstruction Fixation of comminuted mandibular fractures or defects associated with severe trauma Unique Features One single screw head design for all screw diameters 2.0, 2.3 and 2.7 mm Plates accommodate multiple screw diameters and designs Precontoured reconstruction plates Dedicated low profile plates for primary reconstruction 2.0 mm Lag Screw Module Indications 2.0mm diameter screws available in 30, 33, 36, 39 and 42mm lengths for lag screw fixation of mandibular and condylar fractures and osteotomies Unique Features Includes all necessary instrumentation for lag screw technique Dedicated module allows for expedient access 2.0 mm MMF Self Drilling Screw Module Indications Temporary maxillomandibular fixation providing indirect stabilization of the maxilla and mandible Unique Features Stainless steel screw design for maximum strength Optimized head design for securing wires or elastics Self-drilling for easy, one step insertion

9 The Leibinger Universal 2 Color System The color coding of the screw diameter The color coding of the modules 1.2 mm mm mm mm mm mm Upper-Face Fixation Module 1.7 mm Mid-Face Fixation Module 2.0 mm MP Mini Plating Module 1.7 / 2.0 / 2.3 mm Orthognathic Fixation Module 2.0 / 2.3 mm Mandible Fixation Module 2.0 / 2.3 mm Mandible Fracture Module 2.0 / 2.3 mm Mandibular Reconstruction Module 2.0 mm Lag Screw Module 2.0 mm MMF Self Drilling Screw Module The measurement of the screw length and the diameter The color coding of the screw types Screw length definition refers to the length of the thread only Screw Diameter Self Tapping Screw Self Tapping Mini Plating Screw Self Tapping Emergency Screw Self Drilling Screw Self Tapping Locking Screw Example for the measurement of the screw length and the diameter in combination with the screw type 1.7 mm Mid-Face, Self Tapping Screw 1.7 mm Mid-Face, Locking Screw 6.0 mm 6.0 mm 1.7 x 6 mm screw 1.7 mm 1.7 x 6 mm screw 1.7 mm

10 Upper - Face Fixation Module Storage Upper-Face Fixation Module without Inlay Inlay for Upper-Face Plates Screw Disc for 1.2 mm Bone Screws, empty Screw type marker 1.2 mm Self Tapping Screws Screw type marker 1.2 mm Self Drilling Screws Bone Screws, Cross Pin Example 6.0 mm 1.2 mm 1.2 mm Self Tapping 1.4 mm Self Tapping (Emergency) Non- 5/ea. 1.2 x 6 mm screw / illustrated scale 2:1 4/ea x 3 mm x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm Non- 5/ea. Instruments illustrated scale 1:2 1.4 x 5 mm screw / illustrated scale 2: x 3 mm x 5 mm x 7 mm x 9 mm mm Self Drilling Order No. Instruments Non- 5/ea. 1.2 x 4 mm screw / illustrated scale 2:1 4/ea x 3 mm x 4 mm Screwdriver handle, Metal, for Upper-Face and Mid-Face 1.2 mm/1.7 mm Screwdriver Blade for Upper-Face and Mid-Face 1.2 mm 10

11 1.2 Upper - Face Plates Malleable Plates Profile Height: 0.5 mm Straight Plates 24 holes, condensed holes D Plates 2x2 holes x2 holes x6 holes x10 holes Orbita Plate Double Y Plate 10 holes, condensed holes Grey item numbers reference sterile products 11

12 Upper - Face Fixation Module Profile Height: 0.5 mm Burr Hole Cover Plates with removable tab for simple handling 7 mm mm mm mm Profile Height: 0.3 mm Orbital Floor Plates Isolated small Template small/medium Basic medium Template small/medium Complex large Template large mm 12

13 Standard Plates Profile Height: 0.6 mm Straight Plates 8 holes holes D Plates 2x2 holes x2 holes x6 holes x10 holes L Plate 90 T Plate Double Y Plate Orbita Plates R L 8 holes right right left left 7 holes holes holes holes Grey item numbers reference sterile products 13

14 Upper - Face Fixation Module Profile Height: 0.6 mm Profile Height: 0.4 mm Burr Hole Cover Plates Orbital Floor Plates 7 mm mm mm Basic medium Complex large Template medium Template large Dynamic Mesh Profile Height: 0.6 mm Profile Height: 0.3 mm Standard Malleable 90 x 90 mm x 120 mm x 200 mm x 40 mm x 85 mm x 120 mm mm 14

15 Drill Bits Drill Bits for 1.2 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 0.9 mm 46 mm Stryker mm 1.0 mm 50 mm Stryker mm 1.05 mm 54 mm Stryker mm 1.0 mm 50 mm Dental mm 1.05 mm 54 mm Dental Grey item numbers reference sterile products 15

16 Upper - Face Fixation Module Instrument Set Upper-Face Order No. Description Instrument Tray Upper-Face / Mid-Face Plate/Screw Forceps, Angled, Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left Upper-Face / Mid-Face Plate Cutter / Bender Right Upper-Face / Mid-Face Prong Bender In-Situ Plate Cutter Universal Screwdriver Handle, Metal mm/1.7 mm Screwdriver Blade Bone Repositioning Instrument Repositioning Pin Drill Bit, diameter 2,0 x 13 mm, total length 62 mm Universal Drill Guide Handle 1.2 mm 16

17 Mid - Face Fixation Module Storage Mid-Face Fixation Module without Inlay Inlay for Mid-Face Plates, Standard Profile Inlay for Mid-Face Plates, Low Profile Inlay for Mid-Face Meshes, Low Profile Screw Disc for 1.7mm Bone Screws Plate type marker Malleable Plate type marker Standard Plate type marker GSP Screw type marker 1.7 mm Self Tapping Screw Screw type marker 1.7 mm Self Drilling Screw Bone Screws, Cross Pin Example 6.0 mm 1.7 mm 1.7 mm Self Tapping 1.7 mm Locking Non- 5/ea. 1.7 x 6 mm screw / illustrated scale 2:1 4/ea x 3 mm x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm Non- 5/ea. 1.7 x 6 mm screw / illustrated scale 2: x 4 mm x 5 mm x 6 mm mm Self Tapping (Emergency) 1.9 x 5 mm screw / illustrated scale 2:1 1.7 mm Self Drilling Non- 5/ea. Non- 5/ea. 1.7 x 6 mm screw / illustrated scale 2:1 4/ea x 3 mm x 4 mm x 5 mm x 6 mm x 3 mm x 5 mm x 7 mm x 9 mm Screwdriver Blade for 1.2/1.7 mm Screws illustrated scale 1:2 Order No. Instrument Screwdriver Blade Grey item numbers reference sterile products 17

18 Mid - Face Fixation Module 1.7 Mid-Face Plates Malleable Plates Profile Height: 0.55 mm Straight Plates 24 holes, condensed holes D Plates 2x2 holes x2 holes L-Plates 100 R L R L R L R L 5 holes, 2 mm bar right right left left 5 holes, 5 mm bar right right left leftt 6 holes, 8 mm bar right right left left 6 holes, 12 mm bar right right left left Standard Plates Profile Height: 0.6 mm Straight Plates 4 holes, with bar mm 8 holes holes

19 Profile Height: 0.6 mm Curved Plates 4 holes, curved, with bar holes, curved, with bar holes, curved T-Plate Y-Plates Double Y-Plate 5 holes holes, 4 mm bar holes, 8 mm bar holes D Plates 2x2 holes x2 holes L-Plates 100 R L R L R L R L 5 holes, 2 mm bar right right left left 5 holes, 5 mm bar right right left left 6 holes, 8 mm bar right right left left 6 holes, 12 mm bar right right left left Grey item numbers reference sterile products 19

20 Mid - Face Fixation Module GSP Plates Profile Height: 0.6 mm Profile Height: 0.8 mm L-Plates 100 R L R L R L R L 5 holes, 2 mm bar right right left left 5 holes, 5 mm bar right right left left 6 holes, 8 mm bar right right left left 6 holes, 12 mm bar right right left left Dynamic Mesh Profile Height: 0.6 mm Profile Height: 0.3 mm Standard Malleable 90 x 90 mm x 120 mm x 200 mm x 40 mm x 90 mm x 120 mm mm 20

21 Locking Plates To be used in combination with either locking-, self tapping- or self drilling screws Self-Drilling Self-Tapping Locking Profile Height: 0.8 mm Straight Plate Curved Plate 16 holes holes Y-Plates Double Y-Plate 5 holes, 8 mm bar holes, 12 mm bar holes holes Profile Height: 0.8 mm 3-D Plates L-Plates 100 reversible 2x2 holes x2 holes holes 2 mm bar holes 5 mm bar holes 8 mm bar holes 12 mm bar Grey item numbers reference sterile products 21

22 Mid - Face Fixation Module Drill Bits Drill Bits for 1.7 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.35 mm 50 mm Stryker mm 1.4 mm 54 mm Stryker mm 1.4 mm 54 mm Stryker mm 1.3 mm 79 mm Stryker To be used with Drill Guide / Trocar System mm 1.35 mm 50 mm Dental mm 1.4 mm 54 mm Dental mm 1.4 mm 54 mm Dental mm 1.3 mm 79 mm Dental To be used with Drill Guide / Trocar System Overdrill for lag screw technique mm 1.7 mm 60 mm Stryker 1.7 mm 22

23 Instrument Set Mid-Face Order No. Description Instrument Tray Upper-Face/Mid-Face Plate/Screw Forceps, Angled Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left Upper-Face/Mid-Face Plate Cutter / Bender Right Upper-Face/Mid-Face Prong Bender In-Situ Plate Cutter Universal Screwdriver Handle, Metal mm/1.7 mm Screwdriver Blade Bone Repositioning Instrument Repositioning Pin Drill Bit Universal Drill Guide Handle Drill Guide for 1.7 mm Locking Screws Order No. Optional Instruments Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid Plate Bending Plier, 3-D System 13,5 cm, Storage in Accessory Tray Screw Diameter and Measuring Block, Storage in Accessory Tray mm Screwdriver Blade, short, for 90 Angled Screwdriver (Luhr Fritzemeier) Grey item numbers reference sterile products 23

24 2.0 MP Mini Plating Module Storage mm MP Module without Inlay, Full Size Inlay for Full Size 2.0 MP Module mm MP Module without Inlay, Half Size Inlay for Half Size 2.0 MP Module Screw type marker 2.0 mm Bone Screw Screw type marker 2.0 mm Self-Drilling Screw Bone Screws, Cross Pin Example 6.0 mm 2.0 mm 2.0 mm MP Self Tapping 2.3 mm MP Self Tapping (Emergency) Non- 5/ea. 2.0 x 6 mm screw / illustrated scale 2:1 4/ea x 4 mm x 5 mm x 6 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea. 2.3 x 6 mm screw / illustrated scale 2: x 6 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm Screwdriver Blade for 2.0/2.3 mm MP Screws illustrated scale 1:2 and 1:1 2.0 mm MP Self Drilling Order No. Instruments 2.0 x 6 mm screw / illustrated scale 2: MP Screwdriver Blade Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm Screwdriver Blade, Short, for 90 Angled Screwdriver (Luhr Fritzemeier) 2.0 mm 24

25 2.0 MP Mini Plates Profile Height: 1.0 mm Straight Plates 4 holes, regular holes, 4 mm bar holes, 8 mm bar holes, regular holes, reinforced bar holes, regular L-Plates R L R L R L R L 4 holes, regular right right left left 4 holes, 4 mm bar right right left left 4 holes, 8 mm bar right right left left 5 holes, 8 mm bar right right left left T-Plate Y- and Double Y-Plates 6 holes, regular holes, regular holes, 8 mm bar holes, regular holes, 8 mm bar Grey item numbers reference sterile products 25

26 2.0 MP Mini Plating Module Profile Height: 0.6 mm 3-D Plates, Square Segments or Rectangular Segment Rectangular segment x2 holes x2 holes Profile Height: 0.8 mm Straight Plate 30 holes, regular L-Plates 100 T-Plate Y-Plate R L 9 holes, right holes, left holes holes Orbita Plates 12 holes, curved mm 26

27 Profile Height: 0.6 mm Chin Plates with Advancement Chin Plate, 4 mm bar Chin Plate, 6 mm bar Chin Plate, 8 mm bar Chin Plate, 10 mm bar Dynamic Mesh Profile Height: 0.6 mm Profile Height: 0.3 mm Standard Malleable 90 x 90 mm x 120 mm x 200 mm x 40 mm x 90 mm x 120 mm Grey item numbers reference sterile products 27

28 2.0 MP Mini Plating Module Drill Bits Drill Bits for 2.0 mm MP Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.5 mm 50 mm Stryker mm 1.5 mm 50 mm Stryker mm 1.5 mm 58 mm Stryker mm and 5 mm 1.5 mm 50 mm Dental mm 1.5 mm 58 mm Dental mm 1.5 mm 107 mm Stryker mm (Luhr Fritzemeier) 1.5 mm 21 mm Dental mm (Luhr Fritzemeier) 1.5 mm 29 mm Dental 2.0 mm 28

29 Instrument Set Mini Plating Order No. Description Instrument Tray 2.0 MP Plate/Screw Forceps, Angled, Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Prong Bender mm MP Plate Cutting Plier Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle, Revolving/Rigid /2.3 mm MP Screwdriver Blade Trocar Handle, Sharp Tip Trocar Trocar Drill Guide 2.0 mm MP, Centric Cheek Retractor Depth Gauge Order No. Optional Instruments /2.3 mm MP Screwdriver Blade, Short, for 90 Angled Srewdriver (Luhr Fritzemeier) Grey item numbers reference sterile products 29

30 Orthognathic Fixation Module Storage Orthognathic Fixation Module without Inlay Inlay for Orthognathic Module, Standard Profile Le Fort I Inlay, Low Profile Inlay for Locking Plates, Low Profile Inlay for Mid-Face Meshes, Low Profile Plate type marker Malleable Plate type marker Standard Plate type marker GSP Screw type marker 1.7 mm Self Tapping Screws Screw type marker 1.7 mm Locking Screws Screw type marker 1.7 mm Self Drilling Screws Screw type marker 2.0 mm Bone Screws Screw type marker 2.0 mm Locking Screws Screw type marker 2.3 mm Bone Screws Screw type marker 2.3 mm Locking Screws Bone Screws, Cross Pin Example 6.0 mm 1.7 mm 1.7 mm Self Tapping 1.7 mm Locking 1.7 x 6 mm screw / illustrated scale 2:1 1.7 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 4/ea x 3 mm x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm mm Self Drilling Non- 5/ea. 1.7 x 6 mm screw / illustrated scale 2:1 4/ea x 3 mm x 4 mm x 5 mm x 6 mm Non- 5/ea x 4 mm x 5 mm x 6 mm mm Self Tapping (Emergency) Non- 5/ea. 1.7 x 5 mm screw / illustrated scale 2: x 3 mm x 5 mm x 7 mm x 9 mm / 2.0 / 2.3 mm 30

31 Screwdriver Blade for 1.2/1.7 mm Screws illustrated scale 1:2 Order No. Instrument Screwdriver Blade 1.7 Orthognathic Fixation Plates Malleable Plates Profile Height: 0.55 mm L-Plates 100 R L R L R L R L 5 holes, 2 mm bar right right left left 5 holes, 5 mm bar right right left left 6 holes, 8 mm bar right right left left 6 holes, 12 mm bar right right left left Standard Plates Profile Height: 0.6 mm L-Plates 100 R L R L R L R L 5 holes, 2 mm bar 5 holes, 5 mm bar right right right right left left left left Grey item numbers reference sterile products 6 holes, 8 mm bar right right left left 31 6 holes, 12 mm bar right right left left

32 Orthognathic Fixation Module GSP Plates Profile Height: 0.6 mm Profile Height: 0.8 mm L-Plates 100 R L R L R L R L 5 holes, 2 mm bar right right left left 5 holes, 5 mm bar right right left left 6 holes, 8 mm bar right right left left 6 holes, 12 mm bar right right left left Locking Plates To be used in combination with either locking-, self tapping- or self drilling screws Self-Drilling Self-Tapping Locking Profile Height: 0.8 mm L-Plates 100 reversible 5 holes, 2mm bar holes, 5 mm bar holes, 8 mm bar holes, 12 mm bar Z-Plates reversible 4 holes, small holes, large / 2.0 / 2.3 mm 32

33 1.7 mm Le Fort I Plates advancement Profile Height: 0.9 mm 11 holes, 0 mm advancement right right left left 11 holes, 3 mm advancement right right left left 11 holes, 4 mm advancement right right left left 11 holes, 6 mm advancement right right left left 11 holes, 8 mm advancement right right left left 11 holes, 10 mm advancement right right left left Other 1.7 mm Plates Profile Height: 0.6 mm GSP Z-Plates 4 holes, small left left right right 4 holes, large left left right right Grey item numbers reference sterile products 33

34 Orthognathic Fixation Module Profile Height: 0.6 mm Standard Plates 24 holes holes, 4 mm bar holes, 8 mm bar Profile Height: 0.8 mm Locking Plates 5 holes, 8 mm bar holes, 12 mm bar holes holes Profile Height: 0.6 mm Pre-Bent Chin Plates with Advancement 4 mm mm mm mm mm / 2.0 / 2.3 mm 34

35 2.0 Mandibular Bone Screws, Cross Pin Example 6.0 mm 2.0 mm 2.0 mm Self Tapping 2.0 mm Locking 2.0 x 6 mm screw / illustrated scale 2:1 2.0 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm mm Self Tapping 2.3 mm Locking Non- 5/ea. 2.3 x 6 mm screw / illustrated scale 2: x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea. 2.3 x 6 mm screw / illustrated scale 2: x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Screwdriver Blade for 2.0/2.3 mm Screws illustrated scale 1:2 Order No. Instrument /2.3 mm Screwdriver Blade Grey item numbers reference sterile products 35

36 Orthognathic Fixation Module 2.0 mm Orthognathic Plates Profile Height: 1.5 mm with slider / 1.0 mm without slider Sagittal Split Sliding Plate Not for smartlock Sagittal Split Sliding Plate Locking Malleable Locking Profile Height: 1.0 mm Sagittal Split Plates, Curved, Locking 6 holes, 6 mm bar holes, 12 mm bar holes, 6 mm bar holes, 12 mm bar Sagittal Split Drill Bits Sagittal Split Drill Bits for 2.0/2.3 mm Screws illustrated scale 1:1 Non- for Screw Diameter Total Shaft End to 20 mm 1.6 mm 102 mm Stryker to 20 mm 1.6 mm 102 mm Dental to 20 mm 1.9 mm 102 mm Stryker to 20 mm 1.9 mm 102 mm Dental 1.7 / 2.0 / 2.3 mm 36

37 Use of the Sagittal Split Drill Bits The colored scale at the proximal end of the shaft indicates the required length of the screw as the drill shaft goes through the drill guide. Each color band indicates a screw length, e.g.: green = 10 mm, yellow = 12 mm, red = 14 mm, black = 16 mm, orange = 18 mm, white = 20 mm The color code scale is explained on the Orthognathic module, on the lid of the Mandibular module and on the Screw length measuring block Drill Bits Drill Bits for 1.7 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.35 mm 50 mm Stryker mm 1.4 mm 54 mm Stryker mm 1.4 mm 54 mm Stryker mm 1.3 mm 79 mm Stryker To be used with Drill Guide / Trocar System mm 1.35 mm 50 mm Dental mm 1.4 mm 54 mm Dental mm 1.4 mm 54 mm Dental mm 1.3 mm 79 mm Dental To be used with Drill Guide / Trocar System Overdrill for lag screw technique mm 1.7 mm 60 mm Stryker Grey item numbers reference sterile products 37

38 Orthognathic Fixation Module Drill Bits for 2.0/2.3 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 115 mm Stryker mm 1.6 mm 115 mm Dental mm 1.9 mm 115 mm Stryker mm 1.9 mm 115 mm Dental mm 1.6 mm 85 mm Stryker mm 1.6 mm 85 mm Dental mm 1.9 mm 85 mm Stryker mm 1.9 mm 85 mm Dental mm 1.6 mm 58 mm Stryker mm 1.6 mm 58 mm Dental mm 1.9 mm 58 mm Stryker 1.7 / 2.0 / 2.3 mm 38

39 Instrument Set Orthognathic Order No. Description Instrument Tray Orthognathic Plate / Screw Forceps, Angled Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left, Upper-Face / Mid-Face / Orthognathic Plate Cutter / Bender Right, Upper-Face / Mid-Face / Orthognathic Orthognathic Trocar Handle, Sharp Tip, Fixed Trocar Cheek Retractor Depth Measuring Gauge Positioning Screw Drill Guide for 2.0 and 2.3 Screws Trocar Drill Guide for 2.0 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws, Centric Universal Screwdriver Handle, Metal, Upper-Face / Mid-Face / Orthognathic Universal Drill Guide Handle Drill Guide for 1.7 mm Locking Screws Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid /2.3 mm Screwdriver Blade /1.7 mm Screwdriver Blade, Upper-Face / Mid-Face / Orthognathic Order No. Optional Instruments Angled Screwdriver (Luhr Fritzemeier) /2.3 mm Screwdriver Blade, Short, for 90 Angled Screwdriver (Luhr Fritzemeier) mm Screwdriver Blade, Short, for 90 Angled Screwdriver (Luhr Fritzemeier) Trocar Handle 127 x 47 mm Blunt Tip, Revolving Trocar Handle 127 x 47 mm Blunt Tip, Fixed Cheek Retractor, Variable Right Angle Depth Gauge Screw Diameter and Measuring Block, Storage in Accessory Tray 39

40 Mandible Fixation Module Storage Mandible Fixation Module without Inlay Inlay for Mandible Fixation Module Standard Profile Screw type marker 2.0 mm Bone Screws Screw type marker 2.0 mm Locking Screws Screw type marker 2.3 mm Bone Screws Screw type marker 2.3 mm Locking Screws Screw diameter marker 2.0 mm Screw diameter marker 2.3 mm 2.0 Mandibular Bone Screws, Cross Pin Example 6.0 mm 2.0 mm 2.0 mm Self Tapping 2.0 mm Locking 2.0 x 6 mm screw / illustrated scale 2:1 2.0 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm mm Self Tapping 2.3 mm Locking 2.3 x 6 mm screw / illustrated scale 2:1 2.3 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 2.0 / 2.3 mm x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm

41 Screwdriver Blade for 2.0/2.3 mm Screws illustrated scale 1:2 Order No. Instrument /2.3 mm Screwdriver Blade Mandible Fixation Plates All Mandibular Fixation Plates (Mini, 3-D, Fracture and Compression Plates) are compatible with either multidirectional Locking or Neutral Screws. Mini Plates Profile Height: 1.0 mm Straight Plates 4 holes holes holes, 4 mm bar holes, 8 mm bar holes, 8 mm bar holes holes condensed Grey item numbers reference sterile products 41

42 Mandible Fixation Module 3-D Plates Profile Height: 1.0 mm 4x2 holes, square x2 holes, condensed x2 holes, rectangle Fracture Plates Profile Height: 1.5 mm 4 holes, with bar holes holes holes, Compression Plates Profile Height: 1.5 mm For 2.0 mm Screws For 2.3 mm Screws 4 holes holes holes holes / 2.3 mm 42

43 Other Instruments The Plate Holding Caps are to be used in combination with a trocar system for holding plates intraorally prior to drilling and screw insertion. The required plate holding cap should be attached to the end of the trocar cannula (e.g or ). illustrated scale 1:1 Order No. Instruments Plate Holding Cap for Universal Fracture Plates (gold) Plate Holding Cap for Universal Mini Plates (blue) Drill Bits Drill Bits for 90 Angled Screwdriver for 2.0/2.3 Screws illustrated scale 1:1 Order No. for Screw up to Diameter Total Shaft End mm 1.6 mm 19 mm Dental mm 1.6 mm 29 mm Dental mm 1.9 mm 19 mm Dental mm 1.9 mm 29 mm Dental 43

44 Mandible Fixation Module Drill Bits for 2.0/2.3 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 115 mm Stryker mm 1.6 mm 115 mm Dental mm 1.9 mm 115 mm Stryker mm 1.9 mm 115 mm Dental mm 1.6 mm 85 mm Stryker mm 1.6 mm 85 mm Dental mm 1.9 mm 85 mm Stryker mm 1.9 mm 85 mm Dental mm 1.6 mm 58 mm Stryker mm 1.6 mm 58 mm Dental mm 1.9 mm 58 mm Stryker 2.0 / 2.3 mm 44

45 Instrument Set Mandible Fixation / Fracture PLATE/SCREW FORCEPS CHEEK RETRACTOR VARIABLE CHEEK RETRACTOR /2.3mm TAPS / mm DRILL GUIDE COMPRESSION mm DRILL GUIDE mm DRILL GUIDE mm DRILL GUIDEE COMPRESSION N TROCAR DEPTH MEASURING GAUGE (2x) PLATE BENDER/CUTTER TROCART HANDLE SCREWDRIVER HANDLE Order No. Description Instrument Tray Mandible Plate/Screw Forceps, Angled Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left Plate Bender/Cutter Right Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid /2.3 mm Screwdriver Blade Universal Mandible Trocar Handle, Fixed Cheek Retractor, Fixed Trocar Trocar Drill Guide for 2.0 mm Screws, Centric Order No. Description Trocar Drill Guide for 2.3 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws for Compression Plates Deepth Measuring Gauge Order No. Optional Instruments Trocar Drill Guide for 2.0 mm Screws, Eccentric Trocar Drill Guide for 2.3 mm Screws, Eccentric Cheek Retractor, Variable Tap 2.0 mm 45

46 Mandible Fracture Module Storage Universal Mandible Fracture Module without Inlay Inlay for Mandibular Fracture Module Screw type marker Bone Screws Screw type marker Locking Screws Screw diameter marker 2.0 mm Screw diameter marker 2.3 mm 2.0 Mandibular Bone Screws, Cross Pin Example 6.0 mm 2.0 mm 2.0 mm Self Tapping 2.0 mm Locking 2.0 x 6 mm screw / illustrated scale 2:1 2.0 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea. 4/ea x 4 mm x 5 mm x 6 mm x 7 mm x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm mm Self Tapping 2.3 mm Locking 2.3 x 6 mm screw / illustrated scale 2:1 2.3 x 6 mm screw / illustrated scale 2:1 Non- 5/ea. 2.0 / 2.3 mm x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm Non- 5/ea x 4 mm x 6 mm /ea x 8 mm x 10 mm x 12 mm x 14 mm x 16 mm x 18 mm x 20 mm

47 Screwdriver Blade for 2.0/2.3 mm Screws illustrated scale 1:2 MMF Screws and Ligature Wire MMF Screws can also be used as Self Tapping Screws Order No. Instrument illustrated scale 2:1 2.0 x 8 mm screw /2.3 mm Screwdriver Blade Non- 4/ea x 8 mm x 12 mm Non- 10/ea. Ligature Wires Blunt, 24 Gauge, Diameter 0.5 x 160 mm Blunt, 22 Gauge, Diameter 0.64 x 160 mm Mandible Fixation Plates Mini Plates Profile Height: 1.0 mm Straight Plates 4 holes 6 holes 4 holes, 4 mm bar 4 holes, 8 mm bar holes, 8 mm bar holes holes condensed Grey item numbers reference sterile products 47

48 Mandible Fracture Module 3-D Plates Profile Height: 1.0 mm 4x2 holes, square x2 holes, condensed x2 holes, rectangle Fracture Plates Profile Height: 1.5 mm 4 holes holes holes, with bar holes holes, with bar holes, angled, with bar holes, 140, with bar holes, 115, with bar / 2.3 mm 48

49 Compression Plates Profile Height: 1.5 mm For 2.0 mm Screws For 2.3 mm Screws 4 holes holes holes holes Other Instruments illustrated scale 1:1 For instructions how to use the Plate Holding Caps please refer to page 44 Order No. Instruments Plate Holding Cap for Universal Fracture Plates (gold) Plate Holding Cap for Universal Mini Plates (blue) Drill Bits Drill Bits for 90 angled Screwdriver for 2.0/2.3 Screws illustrated scale 1:1 Order No. for Screw up to Diameter Total Shaft End mm 1.6 mm 19 mm Dental mm 1.6 mm 29 mm Dental mm 1.9 mm 19 mm Dental mm 1.9 mm 29 mm Dental 49

50 Mandible Fracture Module Drill Bits for 2.0/2.3 mm Bone Screws illustrated scale 1:1 Non- for Screw up to Diameter Total Shaft End mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 50 mm Stryker mm 1.6 mm 50 mm Dental mm 1.6 mm 115 mm Stryker mm 1.6 mm 115 mm Dental mm 1.9 mm 115 mm Stryker mm 1.9 mm 115 mm Dental mm 1.6 mm 85 mm Stryker mm 1.6 mm 85 mm Dental mm 1.9 mm 85 mm Stryker mm 1.9 mm 85 mm Dental mm 1.6 mm 58 mm Stryker mm 1.6 mm 58 mm Dental mm 1.9 mm 58 mm Stryker 2.0 / 2.3 mm 50

51 Instrument Set Mandible Fixation / Fracture PLATE/SCREW FORCEPS CHEEK RETRACTOR VARIABLE CHEEK RETRACTOR /2.3mm TAPS / mm DRILL GUIDE COMPRESSION mm DRILL GUIDE mm DRILL GUIDE mm DRILL GUIDEE COMPRESSION N TROCAR DEPTH MEASURING GAUGE (2x) PLATE BENDER/CUTTER TROCART HANDLE SCREWDRIVER HANDLE Order No. Description Instrument Tray Mandible Plate/Screw Forceps, Angled Standard Angled Forceps, Locking Straight Forceps, Standard Straight Forceps, Locking Plate Bender Left Plate Bender/Cutter Right Universal Screwdriver Handle, Ratchet Universal Screwdriver Handle Revolving/Rigid /2.3 mm Screwdriver Blade Universal Mandible Trocar Handle, Fixed Cheek Retractor, Fixed Trocar Trocar Drill Guide for 2.0 mm Screws, Centric Order No. Description Trocar Drill Guide for 2.3 mm Screws, Centric Trocar Drill Guide for 2.3 mm Screws for Compression Plates Deepth Measuring Gauge Order No. Optional Instruments Trocar Drill Guide for 2.3 mm Screws, Eccentric Trocar Drill Guide for 2.3 mm Screws, Eccentric Cheek Retractor, Variable Tap 2.0 mm 51