CranioMaxillofacial Fixation (CMF) System - CMF Visionare

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December, 28, 2018 Visionare LLC % Kevin Thomas, Ph.D Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 Re: K180204 Trade/Device Name: CranioMaxillofacial Fixation (CMF) System - CMF Visionare Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 26, 2018 Received: November 27, 2018 Dear Kevin Thomas: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.12.28 for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180204 Device Name CranioMaxillofacial Fixation (CMF) System - CMF Visionare #### Indications for Use (Describe) CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:12px;"> <span style="font-family:Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:12px;"> <span style="font-family:Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary K180204 CranioMaxillofacial Fixation (CMF) System – CMF Visionare Visionare LLC November 26, 2018 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | Visionare LLC<br>12251 Towne Lake Drive<br>Fort Meyers, FL 33913<br>Telephone +1 239-244-2973 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Mariana de Oliveira Quinzani<br>Regulatory Affairs | | Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: +1 858-792-1235<br>Fax: +1 858-792-1236<br>Email: kthomas@paxmed.com | #### DEVICE NAME AND CLASSIFICATION | Trade/Proprietary Name | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | |-------------------------------------|-----------------------------------------------------------| | Common Names | Bone plate; Fixation screws | | Primary Classification Name | Bone Plate | | Primary Classification Regulation | 21 CFR 872.4760, Class II | | Primary Product Code | JEY | | Secondary Classification Name | Intraosseous fixation screw or wire | | Secondary Classification Regulation | 21 CFR 872.4880, Class II | | Secondary Product Code | DZL | | Classification Panel | Dental Products Panel | | Reviewing Branch | Dental Devices Branch | flarson@paxmed.com #### PREDICATE DEVICE INFORMATION Primary Predicate K102641, Mini and Micro Fragments Reconstruction System - NEOFACE, NEOORTHO Produtos Ortopédicos S/A Reference Devices K021642, Synthes Craniofacial Plates, Synthes (USA) K050934, MODUS® Titanium Osteosynthesis System, Medartis, Inc. K033065, 2.0 mm Craniofacial Locking Plates, Synthes (USA) {4}------------------------------------------------ K972322, Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates (sterile version), Walter Lorenz Surgical, Inc. K080694, OsteoMed Modular Locking Fixation System, OsteoMed LP K091144, Synthes MatrixMANDIBLE Preformed Reconstruction Plates, Synthes USA K992682. MODUS 2.5 Mandibular Reconstruction Set. Medartis K063052, Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Incorporated K980199, Synthes® (USA) 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws, Synthes® (USA) K031708, Osteomed Maxillary/LeFort III Distraction System, OsteoMed L.P. K944565, KLS-Martin Micro Osteosynthesis System (1.5 mm), KLS-Martin L.P. K052061, MODUS IMF SCREWS 2.0, Medartis, Inc. ### INDICATIONS FOR USE STATEMENT CranioMaxillofacial Fixation (CMF) System – CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. ### SUBJECT DEVICE DESCRIPTION The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm. The dimensions of the plates are provided in the comparison tables in this summary. ### PERFORMANCE DATA Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937; biocompatibility testing according to ISO 10993-5 and ISO 10993-12; dimensional analysis; engineering analysis; mechanical testing to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). No clinical data were included in this submission. ### EQUIVALENCE TO MARKETED DEVICE Visionare LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed devices cited above. The subject device is substantially equivalent to the primary predicate device K102641 in intended use, Indications for Use, designs, materials, and function. The Indications for Use statement for the subject device is identical to that of the primary predicate K102641 except for the names of the devices. A comparison of the Indications for Use Statements and technological characteristics of the subject device, the primary predicate device, and the reference devices is provided in the following tables. Differences in the design features between the subject device and the primary predicate device K102641 are addressed by comparison to the reference devices as listed below. {5}------------------------------------------------ ### Table 1 – Substantial Equivalence 1.5 System Plates | | Subject Device | | Primary Predicate Device | | Reference Device | | | | | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------|-------------|--------------------------------------------------------------------|--| | Comparisons | K180204<br>Mini and Micro Fragments Reconstruction System - CMF Visionare<br>Visionare LLC | | K102641<br>Mini and Micro Fragments Reconstruction System - NEOFACE<br>NEOORTHO Produtos Ortopédicos S/A | | K021642<br>Synthes Craniofacial Plates<br>Synthes (USA) | | | | | | | | | | | | | | | | | | | Indications for Use<br>Statement | CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in<br>selective trauma of the midface, maxillofacial surgery, reconstructive procedures,<br>and selective orthognathic surgery of the maxilla, mandible and chin. | | Mini and Micro Fragments Reconstruction System - NEOFACE is intended<br>for use in selective trauma of the midface, maxillofacial surgery,<br>reconstructive procedures, and selective orthognathic surgery of the maxilla,<br>mandible and chin. | | The Synthes Craniofacial Plates are intended for use in select<br>the midface and craniofacial skeleton; craniofacial surgery re<br>procedures; and selective orthognathic surgery of the maxilla | | | | | | | Plate Designs for<br>Comparison | 1.5 Straight Plates<br>1.5 Rectangular Plates<br>1.5 T Plates<br>1.5 Y Plates<br>1.5 Double Y Plates<br>1.5 L Plates<br>1.5 L 110° Plates<br>1.5 H Plates<br>1.5 X Plates<br>1.5 Z Plates<br>1.5 Orbital Plates<br>1.5 Orbital Floor Plates | | Straight Plates<br>Rectangular Plates<br>T Plates<br>Y Plates<br>Double Y Plates<br>L Plates<br>L 110° Plates<br>H Plates<br>X Plates<br>Z Plates<br>Orbital Plates | | Rectangular Plates<br>Y Plates<br>Double Y Plates<br>L Plates<br>H Plates<br>Z Plates<br>Orbital Plates | | | | | | | Comparison of Designs | | Thickness (mm) | Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | | | | | 1.5 Straight Plates | 1.5 Straight Plates | 0.7 | 8.8 - 79.2 | Straight Plates | 0.7 | 10.3 - 79.2 | | | | | | 1.5 Rectangular Plates | 1.5 Rectangular Plates | 0.7 | | Rectangular Plates | 0.7 | | Rectangular Plates<br>(Box Plates) | 0.7 | | | | | 2x2 hole | | (7.2 - 10.3) x 10.3 | 2x2 hole | | 11.7 x 11.7 | 2x2 (holes) | | (5.0) | | | | 2x3 hole | | 17.4 x 10.3 | 2x3 hole | | 17.4 x 10.3 | | | | | | | 2x4 hole | | 24.4 x 10.3 | 2x4 hole | | 24.5 x 10.3 | | | | | | 1.5 T Plates | 1.5 T Plates | 0.7 | | T Plates | 0.7 | | | | | | | | 3x2 hole | | (11.2 - 15.7) x 11.2 | None | | | | | | | | | 3x3 hole | | (15.2 - 19.7) x 11.2 | 3x3 hole | | 15.2 x 11.2 | | | | | | | 3x4 hole | | (19.2 - 23.7) x 11.2 | 7x7 hole | | 31.2 x 27.2 | | | | | | 1.5 Y Plates | 1.5 Y Plates | 0.7 | | Y Plates | 0.7 | | Y Plates | 0.6 | | | | | 3x3 hole | | (18.0 - 22.5) x 8.9 | 3x2 hole | | (15.6 - 18.5) x 8.9 | 3x3 hole | 22.0 | | | | | 5x4 hole | | (24.9 - 29.4) x 14.5 | None | | | | | | | | 1.5 Double Y Plates | 1.5 Double Y Plates | 0.7 | | Double Y Plates | 0.7 | | Double Y Plates | | | | | | 3x3 hole | | (13.1 - 17.4) x 8.9 | 3x3 hole | | (14.5-17.4) x 8.9 | | | | | | | 5x5 hole | | (18.5 - 23.0) x 14.5 | None | | | 0.6 | (18.0) | | | | 1.5 L Plates | 1.5 L Plates | 0.7 | | L Plates | 0.7 | | | | | | | | 2x2 hole | | (11.4 - 15.7) x 7.2 | 2x2 hole | | (12.8-15.7) x 7.2 | | | | | | 1.5 L 110° Plates | 1.5 L 110° Plates | 0.7 | | L 110° Plates | 0.7 | | L Oblique Plates | 0.6 | | | | | 3x3 hole | | (18.1 - 22.4) x 11.2 | 3x3 hole | | (19.7-21.0) x 11.2 | 2x3 hole | 22.0 | | | | | 3x4 hole | | (22.1 - 26.4) x 11.2 | None | | | 3x4 hole | 27.0 | | | | 1.5 H Plates | 1.5 H Plates | 0.7 | 16.7 x 15.2 | H Plates | 0.7 | 20.4 x 19.2 | H Plates | 0.5 | 19.0 | | | 1.5 X Plates | 1.5 X Plates | 0.7 | 11.2 x 11.2 | X Plates | 0.7 | 11.2 x 11.2 | | | | | | 1.5 Z Plates | 1.5 Z Plates | 0.7 | (10.5 - 13.4) x 11.2 | Z Plates | 0.7 | (11.7-14.6) x 11.1 | Z Plates | 0.6 | (10.9-1 | | | | Subject Device | | | Primary Predicate Device | | Reference Device | | | Reference Device | | | Comparisons | K180204<br>Mini and Micro Fragments Reconstruction System - CMF Visionare<br>Visionare LLC | | | K102641<br>Mini and Micro Fragments Reconstruction System – NEOFACE<br>NEOORTHO Produtos Ortopédicos S/A | | K021642<br>Synthes Craniofacial Plates<br>Synthes (USA) | | | K050934<br>MODUS® Titanium Osteosynthesis System<br>Medartis, Inc. | | | | | | | | | | | | | | | 1.5 Orbital Plates | 1.5 Orbital Plates | 0.7 | | Orbital Plates | 0.7 | | Orbital Plates | 0.6 | | | | | 6 hole | | 23.0 - 27.3 | 6 hole | | 23.0 | 6 hole | | 34.0 | | | | 8 hole | | 30.6 - 34.8 | 8 hole | | 30.6 | 8 hole | | 41.0 | | | | 10 hole | | 37.9 - 41.9 | 10 hole | | 37.9 | 10 hole | | 49.0 | | | | | | | | | | | | | | | 1.5 Orbital Floor Plates | 1.5 Orbital Floor Plates | 0.3 | | Orbital Floor Plates | 0.3 | | Orbital Floor Plates | | | | | | Orbital Floor Plate, T 0.3 mm | | 59.7 x 36.8 x 0.30 mm | | | | Orbital Floor Plate | (0.2 - 0.4) | 62.2 x 38.5 | | | | Regular Anatomical Orbital Floor<br>Plate, T 0.3 mm | | 29.0 x 17.0 x 0.30 mm | | | | Small | 0.3 | 21.0 x 13.3 | | | | Medium Anatomical Orbital Floor<br>Plate, T 0.3 mm | | 47.7 x 39.6 x 0.30 mm | | | | Medium | 0.3 | 30.6 x 26.6 | | | | Wide Medium Anatomical Orbital<br>Floor Plate, T 0.3 mm | | 53.1 x 39.6 x 0.30 mm | | | | Large | 0.3 | 41.3 x 34.6 | | | | Large Anatomical Orbital Floor<br>Plate, T 0.3 mm | | 61.1 x 53.5 x 0.30 mm | | | | | | | | | | Universal Orbital Floor Plate,<br>T 0.3 mm | | 58.1 x 52.1 x 0.30 mm | Orbital Floor Plate | | 56.7 x 49.9 | | | | | | | | | | | | | | | | | | Plate Material | CP Titanium | | | CP Titanium | | CP Titanium | | | CP Titanium | | | Reference Device | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------|----------------------------------------------| | K050934<br>MODUS® Titanium Osteosynthesis System<br>Medartis, Inc. | | | | | The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery. | | | | | | T Plates<br>Y Plates<br>L 110° Plates | | | | Overall Sizes (mm) | | Thickness (mm) | Overall Sizes (mm) | | (8.0 - 10.0) x 10 | | | | | | T Plates<br>3x2 hole<br>3x3 hole<br>3x4 hole | 0.6 | 12.0 x 12.0<br>17.0 x 12.0<br>21.0 x 12.0 | | (8.0 x 11.0 | Y Plates<br>3x2 hole<br>5x4 hole | 0.6<br>0.7 | (16.0 - 20.0) x 10.0<br>(25.0 - 30.0) x 16.0 | | (18.0 - 21.0) x 11.4 | | | | | (8.0 x 9.0<br>(8.0 x 13.0 | L 110° Plates<br>2x2 hole | 0.6 | (18.0 - 21.0) x 8.0 | | (8.0 x 13.0 | | | | | (10.9-14.7) x 15 | | | | {6}------------------------------------------------ # Table 1 – Substantial Equivalence 1.5 System Plates {7}------------------------------------------------ ### Table 2 – Substantial Equivalence 2.0 System Plates | | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | | | | | | | | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------|-----------------------|---------------------------------------------|------------------------------------|-----------------------------|-----------------------| | Comparison | K180204<br>Mini and Micro Fragments<br>Reconstruction System – CMF<br>Visionare<br>Visionare LLC | K102641<br>Mini and Micro Fragments<br>Reconstruction System – NEOFACE<br>NEOORTHO Produtos Ortopédicos S/A | K021642<br>Synthes Craniofacial Plates<br>Synthes (USA) | K033065<br>2.0 mm Craniofacial Locking Plates<br>Synthes (USA) | K972322<br>Lorenz 1.5mm Neuro Pack/Lorenz 2.0<br>FT Plates (sterile version)<br>Walter Lorenz Surgical, Inc. | K050934<br>MODUS® Titanium Osteosynthesis<br>System<br>Medartis, Inc. | K080694<br>OsteoMed Modular Locking Fixation<br>System<br>OsteoMed LP | | | | | | | | | Indications for Use<br>Statement | CranioMaxillofacial Fixation (CMF)<br>System - CMF Visionare is intended for<br>use in selective trauma of the midface,<br>maxillofacial surgery, reconstructive<br>procedures, and selective orthognathic<br>surgery of the maxilla, mandible and chin. | Mini and Micro Fragments Reconstruction<br>System - NEOFACE is intended for use in<br>selective trauma of the midface, maxillofacial<br>surgery, reconstructive procedures, and<br>selective orthognathic surgery of the maxilla,<br>mandible and chin. | The Synthes Craniofacial Plates are<br>intended for use in selective trauma of the<br>midface and craniofacial skeleton;<br>craniofacial surgery; reconstructive<br>procedures; and selective orthognathic<br>surgery of the maxilla and chin. | Synthes 2.0 mm Craniofacial Locking<br>Plates are indicated for selective trauma of<br>the midface and craniofacial skeleton;<br>craniofacial surgery; reconstructive<br>procedures; and selective orthognathic<br>surgery of the maxilla and chin. | Rigid fixation of cranio, facial and<br>neurological bone. | The MODUS® Titanium Osteosynthesis<br>System is intended for osteotomies and<br>fractures involving any part of the<br>craniofacial skeleton and requiring positional<br>and functional stability. Indications include<br>fixation in the nasoethmoidal, intraorbital,<br>and frontal sinus areas; fixation of<br>comminuted fractures of maxillo-facial and<br>craniofacial areas; tumor surgery for defect<br>bridging; reconstruction of bony structures by<br>means of mesh materials; coverings for burr<br>holes in the skull; trauma of nasal bones;<br>surgical correction of dentofacial<br>deformations; and reconstruction after tumor<br>surgery. | The OsteoMed Modular Locking Fixation<br>System is intended for fracture fixation in<br>cranio-maxillofacial trauma reconstruction,<br>mandibular reconstruction and orthognathic<br>reconstruction.<br>The OsteoMed Modular Locking Fixation<br>System implants and drills are intended for<br>single use only. | | | | | | |…