FUSION LOCK. TitaniumFusionLockPlateSystem- SmalFragmentInstrumentsandImplants. ... perfection guaranteed...
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1 FUSION LOCK... perfection guaranteed... TitaniumFusionLockPlateSystem- SmalFragmentInstrumentsandImplants
2 Wir behalten uns vor, Änderungen und Verbesserungen, durchzuführen und die Instrumente und Geräte ohne besonderen Hinweis in der modifizierten Ausführung auszuliefern. Die Verwendung dieses Kataloges zu anderen Zwecken als ausschließlich der zum Vertrieb von Mahe Medical Produkten ist untersagt. Zuwiderhandlungen werden rechtlich geahndet. Der Nachdruck, auch auszugsweise, ist verboten. We reserve the right of technical modifications and improvements and to supply the instruments and apparatus without specific indication in the modified finish. The use of this catalogue is restriced to actions necessary for selling original Mahe Medical products. The use for any purpose other than selling original Mahe Medical products is Reprinting, even partially, is not allowed.
3 Instructions For Use. (GB)! INSTRUCTIONS FOR USE. (GB) Warning: The implants described may only be used in combination with MAHE products! OSTEOSYNTHESIS STEEL IMPLANTS (Bone: Plates / Screws / Pins / Wires / Clips) non-sterile IMPLANT MATERIAL: Implants made from steel in accordance with ISO 583 stainless steel ; ISO high nitrogen stainless steel manufactured by MAHE MEDICAL GmbH. The surface of these implants is chemically passive: not magnetic. These implants can be combined with the standardised material provided that ist composition lies within the analysis stipulated in the ISO 583 / ISO standard and the required specifications. Material alloys with chrome-nickel (implant steel) components can trigger a so-called chrome-nickel allergy by their nature; there are no other known biocompatible hazards! We would point out that implants only function correctly if the following basic rules are observed: - When selecting implants (bone: plates / screws / pins wires / clips), care must be taken to choose the appropriate implants on the basis of the weight and level of activity of the patient, and the bone fracture to be treated. - Note that by making the correct choice of biomechanics the forces to be transferred by the implants remain low. - Extreme deformation of the implants must be avoided; the cautious bending of wires, plates and pins does not, however, lead to implant damage provided it is done with sufficient care. - Repeated deformation should be avoided at all costs as it will fatigue the implant material. - The re-use of implants is absolutely forbidden (single use). - We strongly advise you to inform patients of the advantages and disadvantages of implants. - Excessive strain as a result of body weight and the level of activity of the patient should be avoided due to the limited strength of the implants. Failure to observe these precautionary measures can have serious consequences for the healing process. INDICATIONS These relate to the current practice of applications of implants in osteosynthesis (e.g. see literature AO/ASIF Instruments and Implants Texhammer*Colton ISBN / ISBN ). CONTRAINDICATIONS Acute and chronic infections; muscle, nerve or vascular diseases that endanger the affected extremity; a lack of bony tissue or poor bone quality (e.g. severe osteoporosis); local bone tumours. Systemic diseases and metabolic disorders; infections and falls; drug dependence; obesity; highly physical activities together with activities involving extreme vibrations which can lead to overstraining of the implants. NOTES The user should record and keep all information provided to the patient. It should be checked before use whether the patient tolerates the material to be implanted. The implants described in these instructions for use may only be used (implanted) by surgeons with the appropriate experience. POSSIBLE NEGATIVE EFFECTS (RISKS) Failure of the fracture to heal, allergy to the material, failure of the product (break, bending), bone deformation and refracture, infection. REMOVAL OF IMPLANTS The implants are normally removed once the fracture has healed. CLEANING AND STERILISATION OF UNSTERILE IMPLANTS Before use, the implants must be sterilised using a validated procedure (autoclaved). MAHE MEDICAL VALIDATED PROCEDURES STERILISER: Steam autoclave: Temperature = to 3 Celsius; Pressure = -. bar (5 to 7 psi) with an exposure time of at least 30 minutes in the packaged state. STERILISER: Autoclave with prevacuum: During the prevacuum phase the air is extracted from the chamber before the steam flows in. Standard circulation for packaged objects: 3 to 35 Celsius; Pressure = 3 bar (7 to 30 psi) with an exposure time of at least to 0 minutes. IMPORTANT NOTES: Every time the implants are used or sterilised you must first check that they function perfectly! In the event of failure to observe these instructions or demonstrable violation, no guarantee or compensation for damages can be provided. 3
4 Set Fusion-Lock Locking Screw - and Plate Set, Set complete includes instruments and implants Titanium Implants included in SET , are manufactured to Raw-Material Standard ISO 583- for plates and ISO for Screws according to biocompatibility ISO Set - listing - content for Set: Set Page up to Page 7 Tray for Fusion Lock Small Fragment Instrument - and Implant SET (Graphic Case)
5 Set Fusion-Lock Locking Screw - and Plate Set for.7 mm / 3.5 mm System Set - Listing - Content: Instruments Description Tray for Fusion Lock small Fragment instrument - and implant Set (Graphic case) Small hexagonal Screw driver for self holding Sleeve (hexagonal flats.5 mm) used for / ø.0 mm Screws Coupling self-holding Sleeve for Screw driver ref Pcs. TRAY T-handle small with AO-quickcoupling Small hexagonal Screw driver AO-shaft ( hexagonal flats.5 mm ) used for ø.7 / ø 3.5 / ø.0 mm screws Small Countersink used for ø.7 / ø 3.5 / ø.0 mm Screws Tap AO-shaft with cortical pitch.5 mm used for cortical Screws Drill bit AO-shaft ø.5 mm x length 0 mm / 85 mm used for cotrical Screws Drill Bit AO - shaft ø.8 mm x length 65 mm calibrated used for cortical locking Screws Drill Bit AO - shaft ø.0 mm x length 65 mm calibrated used for cortical locking Screws Depth gauge used for up to ø.0 mm Screws Universal drill guide 3.5 mm /.5 mm used for tap and drill bit ø.5 mm Small hexalobe Screw Driver AO-shaft with Star Bit 0 used for / 3.5 mm cortical locking Screws Torque limited Screw Driver.5 mm with AO-Quickcoupling used for ø.7 / cortical locking Screws Centring sleeve ø.6 mm used for K-Wire ø.6 mm x 50 mm Threaded drill guide ø.8 mm used for.8 mm Drill Bit Ref Threaded drill guide ø.0 mm used for.0 mm Drill Bit Ref Direct measurement device for K-Wires ø.6 mm for use with drill guide.5 mm / centr. Sleeve.6 mm Kirschner-wire with trocar point and round shaft end ø.6 mm x legth 50 mm 8 Screw forceps
6 Set Fusion-Lock Locking Screw - and Plate Set for.7 mm / 3.5 mm System Set - Listing - Content: Standard Titanium Screw Implants 3.5 mm Titanium Fullthreaded - Cortical Screws 3.5 mm, self-tapping Diameter 0 mm mm mm 6 mm 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 3 mm 36 mm 38 mm 0 mm mm 5 mm 8 mm 50 mm 55 mm 60 mm Pcs ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST 6
7 Set Fusion-Lock Locking Screw - and Plate Set for.7 mm / 3.5 mm System Set - Listing - Content: Standard Titanium Screw Implants 3.5 mm Titanium Fullthreaded - Cortical Screws 3.5 mm, self-tapping Diameter 0 mm mm mm 6 mm 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 3 mm 36 mm 38 mm 0 mm mm 5 mm 8 mm 50 mm 55 mm 60 mm Pcs ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST Set - Listing - Content Titanium Locking Screw Implants.7 mm Titanium Locking Fullthreaded-Cortical Screws.7 mm, self-tapping - cutting Diameter Pcs. 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 35 mm 38 mm 0 mm 5 mm ST ST ST ST ST ST ST ST ST ST ST ST 7
8 Set Fusion-Lock Locking Screw - and Plate Set for.7 mm / 3.5 mm System Set - Listing - Content: Titanium Locking Plate Implants Titanium Plate 3.5 mmn small, straight Combi Hole Low Touch Locking Plate Holes Pcs mm 98.0 mm.0 mm.0 mm 37.0 mm Titanium Reconstruction Plate 3.5 mm small, straight Combi Hole Locking Plate Holes Pcs mm 99.5 mm 0.0 mm 8.5 mm Titanium Anatomical T-Plate 3.5 mm, Oblique Angled Locking Plate Holes Pcs mm 63.0 mm + 3 left + 3 right Titanium Prebend Anatomical Radius Plate 3.5 mm, Volar Locking Plate Holes Pcs. 6.0 mm 6.0 mm left right Set - Listing - Content: Titanium Locking Distance Bolt Titanium Locking Distance Bolt Description Distance Bolt Pcs Set - Listing - Content Instruments: Titanium Washer Implants Titanium Locking Distance Bolt Description / 3.5 mm Washer WT 8
9 Sterilization Container for Set Sterilization Container: Description Container bottom non perforated 580 x 80 x 35 mm Container lid perforated 580 x 80 mm CB CL
10 Instruments for Fusion Locking Plate.7 mm / 3.5 mm System Small hexagonal Screw Driver for self holding Sleeve (hexagonal Flats.5 mm) Used for ø 3.5 /.0 mm screws Coupling Self - Holding Sleeve for Screw Driver REF.: T-Handle Small with AO - Quickcoupling Small Hexagonal Screw Driver - AO Shaft (hexagonal Flats.5 mm) Used for ø.7 / 3.5 /.0 mm screws
11 Instruments for Fusion Locking Plate.7 mm / 3.5 mm System Small Countersink Used for ø.7 / 3.5 /.0 mm screws Tap - AO Description Shaft with cortical Pitch.5 mm Used for cortical screws Shaft ø.0 mm with cancellous Pitch.75 mm ø.0 mm cancellous screws Drill Bit - AO Description Shaft ø.5 mm x length 0 mm / 85 mm Used for cortical screws Drill Bit - AO Description Shaft ø.8 mm x length 65 mm calibrated Used for cortical screws Drill Bit - AO Description Shaft ø.0 mm x length 65 mm calibrated Used for cortical screws
12 Instruments for Fusion Locking Plate.7 mm / 3.5 mm System Depth gauge Used for ø.7 up to ø.0 mm screws Universal Drill Guide 3.5 mm /.5 mm Used for Tap and ø.5 mm Drill Bit Small Screw Driver - AO Shaft with Star Bit 0 Used for ø.7 / locking screws Torque Limited Screw Driver.5 mm with AO - Quickcoupling Used for.7 / cortical locking Screws
13 Instruments for Fusion Locking Plate.7 mm / 3.5 mm System Centring Sleeve ø.6 mm Used for K - Wire ø.6 mm x 50 mm Threaded Drill Guide Description Threaded Drill Guide ø.8 mm Used for ø.8 mm Drill Bit REF.: Threaded Drill Guide ø.0 mm ø.0 mm Drill Bit REF.: Direct Measurement device for K - Wires ø.6 mm Used for threaded drill guide.5 mm / centr. Sleeve.6 mm K-Wire with trocar point and round Shaft end ø.6 mm x length 50 mm Screws Forceps RECOMMENDED ADDITIONAL GENERAL INSTRUMENTS ARE INCLUDED IN SMALL FRAGMENT CATALOGUE, STEEL IMPLANTS! 3
14 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Screw Implants Product description: Titanium Locking Fullthreaded - Cortical Screws, self-tapping Important Technical Dimensions: Head Diameter ø 6.0 mm Hexalobe Socked Star Bit 0 according to ASTM F53-0 Table A6.8 Head Thread M5 / Pitch 0.8 mm Core Diameter ø.9 mm Thread Pitch 0.8 mm Applicable Drill Bit for Thread Hole ø.8 mm, length 65 mm calibrated Note: Tapping is not applicable for this screws! Material Titanium Alloy according to ISO583-3 and Biocompatibility ISO mm mm mm 6 mm 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 35 mm 38 mm 0 mm mm 5 mm 8 mm 50 mm 5 mm 55 mm 60 mm 65 mm 70 mm Diameter ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST
15 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Screw Implants Product description: Titanium Locking Fullthreaded - Cortical Screws, self-tapping Important Technical Dimensions: Head Diameter ø 6.0 mm Hexalobe Socked Star Bit 0 according to ASTM F53-0 Table A6.8 Head Thread M5 / Pitch 0.8 mm Core Diameter for Cortical Thread ø.9 mm Thread Pitch 0.8 mm Applicable Drill Bit for Thread Hole ø.0 mm, length 65 mm calibrated Note: Tapping is not applicable for this screws! Material Titanium Alloy according to ISO583-3 and Biocompatibility ISO mm mm mm 6 mm 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 35 mm 38 mm 0 mm 5 mm 50 mm 55 mm 60 mm Diameter ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST 5
16 Titanium Fusion - Lock Implants Titanium Locking Distance Bolt Distance Bolt Important Technical Dimensions: Head Diameter ø 6.0 mm Hexalobe Socked width Star Bit 0 according to ASTM F53-0 Table A6.8 Head Thread M5 / Pitch 0.8 mm Material Titanium Alloy according to ISO583-3 and Biocompatibility ISO0993- Titanium Washer / 3.5 mm washer WT Important Technical Dimensions: Material Titanium Alloy according to ISO and Biocompatibility ISO
17 Titanium Fusion - Lock Implants Titanium Standard Screw Implants Product description: Titanium Locking Fullthreaded - Cortical Screws, self-tapping Important Technical Dimensions: Head Diameter ø 6.0 mm Hexalobe Socked width.5 mm Core Diameter for Cortical Thread ø. mm Cortical Thread pitch.5 mm Applicable Tap with.5 cortical pitch Note: Tapping is not necessary! Material Titanium Alloy according to ISO583-3 and Biocompatibility ISO0993- Diameter 0 mm mm mm 6 mm 8 mm 0 mm mm mm 6 mm 8 mm 30 mm 3 mm 3 mm 36 mm 38 mm 0 mm mm 5 mm 8 mm 50 mm 55 mm 60 mm 65 mm 70 mm 75 mm 80 mm ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST ST 7
18 Titanium Fusion - Lock Implants Titanium Standard Screw Implants Product description: Titanium Locking Fullthreaded - Cancellous Screws ø.0 mm Important Technical Dimensions: Head Diameter ø 6.0 mm Hexalobe Socked width.5 mm Core Diameter for Cortical Thread ø.9 mm Cortical Thread pitch.75 mm Applicable Drill Bit for Thread hole ø.5 mm, length 0 mm / 85 mm Applicable Tap ø.0 mm with.75 mm Cancellous Pitch Material Titanium Alloy according to ISO583-3 and Biocompatibility ISO0993- Diameter 0 mm ø.0 mm mm ø.0 mm mm ø.0 mm 6 mm ø.0 mm 8 mm ø.0 mm 0 mm ø.0 mm mm ø.0 mm mm ø.0 mm 6 mm ø.0 mm 8 mm ø.0 mm 30 mm ø.0 mm 3 mm ø.0 mm 3 mm ø.0 mm 35 mm ø.0 mm 36 mm ø.0 mm 38 mm ø.0 mm 0 mm ø.0 mm 5 mm ø.0 mm 50 mm ø.0 mm 55 mm ø.0 mm 60 mm ø.0 mm T T T T T T T T T T T T T T T T T T T T T 8
19 Titanium Fusion - Lock Implants Advantage High Fixation Stability Locking Holes Left / Right = Degree Angled! Titanium Fusion - Lock Locking Plate Implants Small Fragment Locking Plates Straight within Combi Holes used with Titanium and Locking Screws in Combination with and ø.0 mm Titanium Standard Screws Applicable for Fixation Ulna / Radius- and Humeral Shaft Fractures Important Technical Dimensions: Thickness 3.0 mm Broad mm Distance between holes mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Plate 3.5 mm small, straight Combi Hole Low Touch Locking Plate 59 mm 7 mm 85 mm 98 mm mm mm 37 mm 50 mm 63 mm Holes
20 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Small Fragment Reconstructions Locking Plates Straight without Combi Holes used with Titanium and Locking Screws Applicable for main Fixation in Pelvic and Acetabular Fractures also theay may sometimes be used in Fractures of the distal Humeral ( dorsal lateral aspect ) and the Clavicle and Calcaneus Important Technical Dimensions: Thickness.8 mm Broad 0 mm Distance between holes mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Reconstruction Plate 3.5 mm, straight without Combi Hole Locking Plate 58 mm 70 mm 8 mm 9 mm 06 mm 8 mm mm 66 mm 90 mm mm 38 mm 6 mm Holes
21 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Small Fragment Reconstructions Locking Plates Straight with Combi Holes used with Titanium and Locking Screws in Combination with and ø.0 mm Titanium Standard Screws Applicable for main Fixation in Pelvic and Acetabular Fractures also theay may sometimes be used in Fractures of the distal Humeral ( dorsal lateral aspect ) and the Clavicle and Calcaneus Important Technical Dimensions: Thickness.8 mm Broad 0 mm Distance between holes.5 mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Reconstruction Plate 3.5 mm, straight without Combi Hole Locking Plate 70.5 mm 80.0 mm 99.5 mm.0 mm 8.5 mm 3.0 mm 7.0 mm 0.0 mm 30.0 mm 59.0 mm 88.0 mm 37.0 mm Holes
22 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Small Fragment Anatomical T-Plates, Oblique Angled used with Titanium and Locking Screws in Combination with and ø.0 mm Titanium Standard Screws Applicable for main Fixation Fractures, dorsal aspect of the distal Radius left and right Important Technical Dimensions: Thickness.5 mm Low Profile Broad 0 mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product descritpion: Titanium Anatomical T-Plate 3.5 mm, Oblique Angled Locking Plate 5 mm 5 mm 63 mm 63 mm 75 mm 75 mm Holes 8 hole LEFT 8 hole RIGHT 0 hole LEFT 0 hole RIGHT 5 hole in shaft + 3 hole in head LEFT 5 hole in shaft + 3 hole in head RIGHT
23 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Small Fragment Prebend Anatomical Radius plates with Titanium and Combination with and ø.0 mm Titanium Standard Screws Applicable for main Fixation in Fractures, volar aspect of the distal Radius left and right Important Technical Dimensions: Thickness.5 mm Low Profile Broad 0 mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Prebend Anatomical Radius Locking Plate Holes 3 hole in shaft + 6 hole in head LEFT 3 hole in shaft + 6 hole in head RIGHT hole in shaft + 6 hole in head LEFT hole in shaft + 6 hole in head RIGHT
24 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Proximal Humeral Plates used with Titanium Locking screws in Combination with and ø.0 mm Titanium Standard Screws. Applicable for Proximal Humeral Fractures Left and Right. Important Technical Dimensions: Thickness 3.0 mm Broad/Shaft mm Broad/Head 0 mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Humeral Locking Plate 90 mm 0 mm Holes
25 Titanium Fusion - Lock Implants Titanium Fusion - Lock Locking Plate Implants Calcaneus Plates with Titanium and Locking Screws in Combination with and ø.0 mm Titanium Standard Screws Applicable for Fixation Calcaneus Fractures left and right Important Technical Dimensions: Thickness.5 mm Low Profile Broad 0 mm Material Unalloyed Titanium according to ISO583- Grade B and Biocompatibility ISO0993- Product description: Titanium Calcaneus Locking Plate 6 mm 6 mm 7 mm 7 mm Holes 3 hole in shaft + 6 hole in head LEFT 3 hole in shaft + 6 hole in head RIGHT hole in shaft + 6 hole in head LEFT hole in shaft + 6 hole in head RIGHT
26 Titanium Fusion - Lock Implants Titanium Fusion - Lock: Locking Plate Implants Distal Humeral Locking Plates, Medial used with Titanium Ø.7mm and Ø 3.5mm Locking Screws in Combination with Ø 3.5mm and Ø.0mm Titanium Standard Screws Applicable for Fixation Distal Humeral Fractures Material. Titanium Alloy ISO583 3 Important technical Dimensions: Thickness.0mm Broad.5mm Material Titanium alloy according to ISO583 3 and Biocompatibility ISO0993 Product description: Titanium Humeral Locking Plates, Medial 80 mm 06 mm 3 mm 58 mm Holes mm
27 Titanium Fusion - Lock Implants Titanium Fusion - Lock: Locking Plate Implants Distal Tibia Locking Plates, Medial used with Titanium Ø.7mm and Ø 3.5mm Locking Screws in Combination with Ø 3.5mm and Ø.0 mm Titanium Standard Screws Applicable for Fixation Distal Tibia Fractures Material. Titanium Alloy ISO583 3 Important technical Dimensions: Thickness.0 mm Broad / Shaft.0 mm Broad / Head 3.0mm Distance Holes / Shaft 3mm Material Titanium alloy according to ISO583 3 and Biocompatibility ISO0993 Product Description: Titanium Tibia Distal Locking Plates, Medial Holes Right Plates Left Plates 7 mm mm mm 98 mm mm 5 mm
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30 Friedrich-Wöhler-Str Emmingen, Germany Phone Fax info@mahe-med.de Photographs in this catalogue are not actual size, although we have tried to provide clear and precise photographs and descriptions. All original photographs, illustrations and text in this catalogue are fully protected by copyright. No part may be reproduced in any form without written permission of Mahe Medical GmbH. All specifications in this catalogue are subject to change without notice.
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Ordering Information. Low Profile 3.5 mm Pelvic System. The comprehensive solution for pelvic fracture fixation.
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