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Titanium osteosynthesis | CMF surgery - LevelOne

Implants | CMF

LevelOne fixation

The innovative LevelOne osteosynthesis system

With LevelOne we offer you an innovative storage system for osteosynthesis in CMF surgery. It consists of basic modules, storage modules as well as color-coded packs of screws which are filled individually and can be combined according to requirements. They offer surgeons the option of choosing between preconfigured storage modules or configuring their own system. There are no limits to the configuration options.

LevelOne – a coherent approach, which has become indispensable in osteosynthesis. The modules are designed for applications in the following anatomical areas or disciplines respectively:
LevelOne Cranium

  • LevelOne Midface
  • LevelOne Mandible
  • LevelOne Orthognathics
CMF surgery - LevelOne plates and meshes

Plates and meshes

The LevelOne system provides plates and meshes for the entire area of the skull and is matched for the corresponding requirements:

  • Pure titanium plates and meshes in a large variety of profiles and shapes
  • "Rigid Blue" plates made of titanium alloy
  • Fixed-angle plates
  • L1® Smart3D osteosynthesis implants - anatomically pre-shaped midface and mandibular implants

Due to innovative tabs on every individual plate, traceability and identification are assured 100% without affecting the modularity of the LevelOne philosophy - even for the flattest profile.

CMF surgery - LevelOne screws

Screws

All screws are available in clip magazines that make charging, screw-picking and reordering an easy process. 

maxDrive® screws are available as standard, emergency and drill-free screws in a variety of diameters and lengths. All screws are color-coded for easy identification.

CMF surgery - LevelOne instruments

Instruments

Matched to the relevant applications, color-coded instruments are available in a large choice for easy and intuitive handling. In essence this includes:

  • Screwdrivers and screwdriver blades
  • Bending and cutting instruments 
  • Plate holding instruments
  • Drilling jigs and drills

Our LevelOne modules

L1® Customized

CMF surgery - L1® Customized

NEW | L1® Customized

Customized storage system

Indications / Field of Use:

The L1® Customized system is used to store plates and screws for surgery in the field of oral and maxillofacial surgery. The flexibility of the L1® Customized storage system is as varied as its fields of application. It provides optimal storage for plates and screws from the fields listed below.

  • Neurosurgery
  • Orthognathic surgery
  • Trauma
  • Reconstruction
CMF surgery - L1® Customized

Features:

  • The L1® Customized system can be tailored specifically to suit customer requirements.
  • In addition to the standard plates from the 1.0 / 1.5 Micro and 2.0 Mini systems, larger reconstruction plates as well as three-dimensionally pre-bent Smart3D plates can also be included in the system.
  • In combination with the flexibly configurable screw modules for maxDrive® screws with diameters of 1.0 mm to 3.0 mm, the L1® Customized system creates optimum conditions for successful surgical procedures.

Benefits:

  • Absolute fulfillment of the customer request’s due to flexible combination of needed plates and screws
  • Cost efficiency solution for every customer because just the needed articles must be purchased
  • Protect your initial investment by adding additional parts to the system in a later stage

Cranium

L1® Cranium

NEW | L1® Cranium

Neuro osteosynthesesis

Application areas:

The L1® Cranium System is used for the treatment of fractures, fixation of osteotomies and bone flaps as well as in the context of reconstructive procedures in the area of the cranial cap.

Features:

  • ultraOne-Platten mit Profilstärke von 0,35 mm und abgerundeter atraumatischer Plattenkontur
  • self-drilling oneDrive screws with optimised point and thread flank design
  • oneDrive screws in single clip and ultraOne plates with break-away tab, marked with item, batch and GTIN number and DataMatrix code for scanning
  • Modular and space-saving storage concept in honeycomb design
L1® Cranium

Benefits:

  • Minimal palpability due to low plate-screw profile and optimal embedding of the implants in the soft tissue
  • Schnelles Eindrehen der oneDrive-Schraube bei geringem Kraftaufwand 
  • Simple recording of all implant data by scanning the DataMatrix code or by reading the plain text
  • 100 % batch traceability and transparent patient-related documentation
  • Cleaning and sterilisation-validated implant modules, suitable for machine reprocessing
CMF surgery - LevelOne 1.0 Cranium

LevelOne 1.0 

Titanium implants for use in craniomaxillofacial osteosynthesis

Indications: 

  • Neurosurgery
  • Frontal and maxillary sinus
  • Oral and preprosthetic surgery
  • Pediatric surgery

Features:

  • Plate profiles: 0.6 mm, 0.3 mm (Burr Hole Covers)
  • Mesh profiles: 0.1 mm, 0.2 mm, 0.3 mm, 0.6 mm
  • Screw diameter: 1.0 mm/ 1.2 mm
CMF surgery - LevelOne 1.5 Cranium

LevelOne 1.5

Titanium implants for use in craniomaxillofacial osteosynthesis

Indications:

  • Neurosurgery
  • Frontal and maxillary sinus
  • Naso- and intra- orbital region 
  • Fixation of bone grafts
  • Ortho-anchorage 
  • Midfacial trauma

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 1.0 mm
  • Mesh profiles: 0.3 mm, 0.6 mm
  • Screw diameter: 1.5 mm/ 1.8 mm (Emergency Screw)
CMF surgery - LevelOne low profile neuro cranium

LevelOne Low Profile Neuro

Level One Fixation Low Profile Neuro - Titanium implants for use in Neurosurgery

Indications: 

  • Craniotomies
  • Cranioplasties
  • Craniofacial surgery
  • Pediatric neurosurgery
  • Bony defects of mastoid, cranial, orbital and skull base regions
  • Neuro trauma

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm 
  • Mesh profiles: 0.3 mm
  • Screw diameter: 1.5 mm Drill-free maxDrive Screws

Benefits:

  • 25% lower profile than our standard 1.5-mm system
  • Minimal palpability
  • Color coded system – purple plates
CMF surgery - LevelOne SAM Kranium

Standard Approach Mesh

Pre-contoured titanium mesh implants for use in cranial osteosynthesis

Indications:

  • Reconstruction of cranial defects

Features:

  • Mesh profile: 0.6 mm
  • Screw diameter: 1.5 mm Drill-free maxDrive Screws

Benefits:

  • Pre-contoured titanium mesh implants and templates for 11 standard neurosurgical approaches
  • Mesh sizes and shapes were created using a compilation of adult CT scans to develop the best possible “average” fit
  • Each implant comes with detachable identification tag to aid in orientation and to maximize inventory control
CMF surgery - LevelOne flap fix kit cranium

Sterile Neuro Flap Fix Kit

For the simple and stable fixation of cranial bone flaps and fractures

Features:

The sterile Neuro Flap Fix Kit includes:

  • 3x 2-hole low profile micro plates
  • 6x 1.5 mm maxDrive® screws, 4.0 mm long, self-drilling 

Benefits:

  • Quick and simple, always ready to use
  • Guaranteed cleanliness and sterility
  • Complete traceability

Midface

L1® Smart3D plates

NEW | L1® Smart3D

Anatomically pre-shaped midface and mandibular implants

Indications:

  • The L1® Smart3D osteosynthesis implants are particularly used to treat fractures, for the fixation of osteotomies and for reconstructive surgery in the midface and mandible.

Features:

  • Holistic portfolio of three-dimensional preformed Smart3D implants.
  • Functional plate design
  • Standard size per plate type
  • Plate profile: 0.6 mm (midface), 1.0 mm (mandible)
L1® Smart3D Module

Benefits:

  • Supplements the standard implants
  • Option of reduction against the plate (guide bracket and hook as positioning and reduction aid) 
  • Unisex plates
  • Holistic and efficient treatment of midfacial and mandibular fractures
  • Clearly structured portfolio
CMF surgery - LevelOne 1.5 Midface

NEW | L1® Midface

Midface osteosynthesis

Indications: 

  • The L1® Midface system is used in particular for the treatment of fractures, fixation of osteotomies, and within the context of reconstructive procedures in the midface area.

Features:

  • maxDrive® screws in single clip and osteosynthesis plates with detachable ID tag marked with article number, batch number, GTIN number, and DataMatrix code for scanning. 
  • Storage trays in honeycomb design, which meet today’s requirements of optimized reprocessing capabilities.  
  • New and improved bending and cutting instruments with uniform, ergonomic handle design, and spring-loaded closure. 

Benefits:

  • The possibility to document all the relevant data, even in the case of very small implants.  
  • Easy recording by reading plain text or scanning the DataMatrix code. 
  • 100 % batch traceability and transparent, patient-related documentation. 
  • Cleaning and sterilization-validated implant modules, which are suitable for machine reprocessing.      
     
CMF surgery - LevelOne 1.5 Midface

LevelOne 1.5

Titanium implants for use in craniomaxillofacial osteosynthesis

Indications: 

  • Neurosurgery
  • Frontal and maxillary sinus
  • Naso- and intra- orbital region 
  • Fixation of bone grafts
  • Ortho-anchorage
  • Midfacial trauma

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 1.0 mm
  • Mesh profiles: 0.3 mm, 0.6 mm
  • Screw diameter: 1.5 mm/ 1.8 mm (Emergency Screw)
CMF surgery - LevelOne 2.0 Midface

LevelOne 2.0

Titanium implants for use in craniomaxillofacial osteosynthesis 

Indications: 

  • Fixation of bone grafts
  • Primary and secondary reconstruction of mandibular defects
  • Mandibular fractures
  • Fractures in cranial high-load regions 

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 0.7 mm, 0.8mm, 1.0 mm, 1.4 mm 
  • Screw diameter: 2.0 mm/ 2.3 mm (Emergency Screw)
CMF surgery - LevelOne Midface

LevelOne Midface

Titanium implants for use in maxillofacial osteosynthesis 

Indications: 

Use in the repair and the reconstruction of the craniofacial skeleton due to trauma, especially for the osteosynthesis of

  • Le Fort planes
  • Naso- and intra-orbital region
  • Orbital rim
  • Zygomatic complex
  • Frontal and maxillary sinus

Features:

  • Plate profiles: 0.6 mm, 0.8 mm, 1.0 mm
  • Screw diameter: 1.5 mm / 1.8 mm (Emergency Screw) maxDrive Screws

Benefits:

  • maxDrive® 1.5 mm micro screws can be used with one single blade for all available plate profiles
  • Color codation - 11 different plate shapes in 3 different colors according to their thickness facilitate selection
  • All plates are provided with a tab for secure grip, easy placement and full traceability thanks to marked lot numbers on the plates’ surfaces
  • Thanks to plate hole countersinks on the both L-plate sides, plates can be either used on the left and the right side of the patient Inventory is considerably reduced
  • A complete set of standardized instruments for easy contouring, cutting instruments and insertion of the plates is provided within the set
CMF surgery - LevelOne Orbital Trauma Midface

Orbital Trauma Concept - Titanium and resorbable implants for orbital reconstruction

Features:

  • Different plate designs for orbital defects of class I, II, III, IV

Benefits:

  • The trauma section of Strasbourg Osteosynthesis Research Group (S.O.R.G.) has evaluated treatment principles according to size and extension of the fracture site based on the recognized classification of Jaquiéry et al.
  • Additional instruments and tools are there to aid reconstruction in the operating room.
  • The optimized S.O.R.G. orbita floor implant offers a considerable support to the eye globe. Various cutting options allow uneventful adjustment of the implant. The implant can be applied on both sides of the orbit. In cases with lacking bony support, the central medial bar can be seated posteriorly in order to additionally stabilize the position of the eye.
     
CMF surgery - MMF screw Midface Mandible Orthognathics

MMF Screws – for Maxillomandibular Fixation

Indications:

The KLS Martin MMF Screws are intended for use in maxillomandibular fixation (MMF) to provide stabilization of fractures of the maxilla, mandible, or both.

Features:

  • Screw Diameter 2.0 mm
  • Screws available in different lengths

Benefits:

  • As the screws are self-drilling, there is no need to pre-drill - the risk to hurt tooth roots is thus minimized 
  • For highest stability the MMF screws are also available made from steel 
  • Groove under screwhead secures wires or elastics

Mandible

L1® Smart3D plates

NEW | L1® Smart3D

Anatomically pre-shaped midface and mandibular implants

Indications:

  • The L1® Smart3D osteosynthesis implants are particularly used to treat fractures, for the fixation of osteotomies and for reconstructive surgery in the midface and mandible.

Features:

  • Holistic portfolio of three-dimensional preformed Smart3D implants.
  • Functional plate design
  • Standard size per plate type
  • Plate profile: 0.6 mm (midface), 1.0 mm (mandible)
L1® Smart3D Module

Benefits:

  • Supplements the standard implants
  • Option of reduction against the plate (guide bracket and hook as positioning and reduction aid) 
  • Unisex plates
  • Holistic and efficient treatment of midfacial and mandibular fractures
  • Clearly structured portfolio
CMF surgery - LevelOne 2.0 UK

LevelOne 2.0

Titanium implants for use in craniomaxillofacial osteosynthesis. 

Indications: 

  • Fixation of bone grafts
  • Primary and secondary reconstruction of mandibular defects
  • Mandibular fractures
  • Fractures in cranial high-load regions 

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 0.7 mm, 0.8mm, 1.0 mm, 1.4 mm 
  • Screw diameter: 2.0 mm/ 2.3 mm (Emergency Screw)
CMF surgery - LevelOne 2.3 UK

LevelOne 2.3

Titanium implants for use in craniomaxillofacial osteosynthesis 

Indications:

  • Fractured atrophic mandibles
  •  Unstable oblique, angle and defect fractures
  • Mandibular fractures in non-compliant patients
  • Mandibular reconstruction in combination with interpositional non-vascularized bone grafts

Features:

  • Plate profiles: 1.5 mm 
  • Screw diameter: 2.3 mm/ 2.5 mm (Emergency Screw)

ThreadLock TS 2.0 - 2.7

Multidirectional Locking Plate System for use in craniomaxillofacial osteosynthesis

Indications: 

  • Locking fracture management
  • Stable mandibular reconstruction
  • Fixation of bone grafts
  • Primary and secondary reconstructions
  • Complex mandibular fractures

Features:

  • Plate profiles: 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm
  • Screw diameter: 2.0 mm, 2.3 mm, 2.7 mm (Standard Screws or Locking Screws)

Benefits:

  • Screws can lock in plates with up to 20º of angulation in each direction
  • All locking plates and screws are colored green
  • All plates can accept locking as well as non-locking screws
  • System includes drill guide for all plate sizes
CMF surgery - LevelOne Rhombus 3D Mandible

Rhombic 3D

Three-dimensional titanium implants for optimal treatment of condylar fractures

Indications:

  • Surgical treatment of deep, medium and high condylar fractures

Features:

  • Plate profile: 1.0 mm
  • Screw diameter: 2.0 mm / 2.3 mm (Standard Screws or Locking Screws)

Benefits:

  • The rhombic shape of the plate takes account of the great variety of pressure and tensile forces involved in the masticatory process, thus ensuring rigid, torsionresistant osteosynthesis
  • Thanks to the rhomboidal lightweight design, the plate provides a central window for perfect control of the fracture gap after reduction
  • Closely positioned screw holes in the cranial part of the plate allow you to place the osteosynthesis screws securely even where space is very limited

L1® Mandible ReconGuide

Resection guides and mini implants for mandibular reconstruction with fibula graft

Indications:

Mandibular resection and reconstruction with microvascular fibular graft

Features:

  • Universal, reusable resection guides that can be used to perform osteotomies of the mandible and fibula according to a defined and coordinated resection pattern.
  • Arrange the resected fibula segments at an angle using the angled fixation bow. 
  • Integrated recesses for osteosynthesis and specially matched and pre-bent mini plates 
L1® Mandible ReconGuide | benefits

Benefits:

  • Defined incision and precise cut surfaces
  • Graft coordinated with and matching the defect, without any manual modeling of bone segments
  • Standardization of conventional resection
  • Significant time savings due to "automated" holding together of the bone segments during osteosynthesis
  • Enables graft fixation while the guide is still in place
MMF Screws – for maxillomandibular Fixation

MMF Screws – for Maxillomandibular Fixation

Indications:

The KLS Martin MMF Screws are intended for use in maxillomandibular fixation (MMF) to provide stabilization of fractures of the maxilla, mandible, or both.

Features:

  • Screw Diameter 2.0 mm
  • Screws available in different lengths

Benefits:

  • As the screws are self-drilling, there is no need to pre-drill - the risk to hurt tooth roots is thus minimized 
  • For highest stability the MMF screws are also available made from steel 
  • Groove under screwhead secures wires or elastics

Orthognathics

CMF surgery - LevelOne 1,5 Orthognathics

LevelOne 1,5

Titanium implants for use in craniomaxillofacial osteosynthesis

Indications: 

  • Neurosurgery
  • Frontal and maxillary sinus
  • Naso- and intra- orbital region 
  • Fixation of bone grafts
  • Ortho-anchorage 
  • Midfacial trauma

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 1.0 mm
  • Mesh profiles: 0.3 mm, 0.6 mm
  • Screw diameter: 1.5 mm/ 1.8 mm (Emergency Screw)
CMF surgery - LevelOne 2.0 Orthognathics

LevelOne 2,0

Titanium implants for use in craniomaxillofacial osteosynthesis 

Indications:

Fixation of bone grafts

  • Primary and secondary reconstruction of mandibular defects
  • Mandibular fractures
  • Fractures in cranial high-load regions 

Features:

  • Plate profiles: 0.3 mm (Burr Hole Covers), 0.6 mm, 0.7 mm, 0.8mm, 1.0 mm, 1.4 mm 
  • Screw diameter: 2.0 mm/ 2.3 mm (Emergency Screw)
CMF surgery - Arnett Orthognathics

Arnett-FAB-Orthognathic-System

Arnett FAB Orthognathic System - Titanium implants and instruments for use in orthognathic surgery

Indications:

  • The Arnett FAB Plates are indicated for titanium osteosynthesis in orthognathic surgery cases

Features:

  • Plate profiles: 0.8 mm, 1.0 mm
  • Screw diameter: 2.0 mm / 2.3 mm (Emergency Screw) 

Benefits:

  • A system of instruments, plates, and screws to improve surgery outcomes 
  • Plates designed to place screws into the thickest bone with minimal bending
  • All plates are reversible – can be used on left or right side
  • All plates have carry tabs to allow direct placement on the bone for passive fitting
CMF surgery - LevelOne BSSO Orthognathics

BSSO Sliding Plate

To support accurate mandibular advancement or setback following bilateral sagittal split osteotomy (BSSO)

Indications:

The BSSO Plate is indicated for mandibular advancement or setback following bilateral sagittal split osteotomy (BSSO)

Features:

  • Plate profiles: 0.8 mm
  • Screw diameter: 2.0 mm / 2.3 mm
  • Maximum advancement: 11 mm, 16 mm, 21 mm 

Benefits:

  • Optimized design for improved flexibility and simultaneous high degree of stability
  • Gradual control of mandibular displacement
  • Stable osteosynthesis following displacement
  • Removable slider secured against loss
CMF surgery - MMF screw Midface Mandible Orthognathics

MMF Screws – for Maxillomandibular Fixation

Indications:

The KLS Martin MMF Screws are intended for use in maxillomandibular fixation (MMF) to provide stabilization of fractures of the maxilla, mandible, or both.

Features:

  • Screw Diameter 2.0 mm
  • Screws available in different lengths

Benefits:

  • As the screws are self-drilling, there is no need to pre-drill - the risk to hurt tooth roots is thus minimized 
  • For highest stability the MMF screws are also available made from steel 
  • Groove under screwhead secures wires or elastics

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