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KLS-Martin Micro Osteosynthesis System (1.5MM): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:

• The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
• The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
• The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
• The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.

Individual Patient Solutions - Ti (IPS-Ti)*: Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton.

Individual Patient Solutions - PEEK (IPS-PEEK)*: Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Individual Patient Solutions - (IPS-PEEK):** The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.

KLS-Martin Micro Osteosynthesis System (1.5mm): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the bones of the skeletal system after a facial fracture or surgery. The bone plate system is composed of bone plates and screws of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 1.0mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.

KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bony surface and stabilize the bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.

KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.

Individual Patient Solutions - Ti (IPS-Ti)*: The Individual Patient Solutions - Ti (IPS-Ti) is a preformed implant manufactured from Titanium material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - PEEK (IPS-PEEK)*: The Individual Patient Solutions - PEEK (IPS-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

Individual Patient Solutions - (IPS-PEEK)**: The Individual Patient Solutions - (IPS-PEEK) is a preformed implant manufactured from PEEK material offered to the end-user as a sterile product. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.

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