KLS Martin Individual Patient Solutions

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. KLS-Martin L.P. Pam Martin Regulatory Affairs Project Management 11201 Saint Johns Industrial PKWY S Jacksonville, Florida 32246 7/18/2022 Re: K210731 Trade/Device Name: KLS Martin Individual Patient Solutions Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZJ, LLZ Dated: June 27, 2022 Received: June 28, 2022 Dear Pam Martin: 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K210731 Device Name KLS Martin Individual Patient Solutions ### Indications for Use (Describe) KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery. KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age), adolescents (12 years of age - 21 years of age), and adults. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. A registered trademark symbol is located to the right of the word "martin". Mài Bl KLS-Martin L.P. Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com # K210731 510(k) Summary 21 CFR 807.92 | Submitter: | KLS-Martin L.P.<br>11201 Saint Johns Industrial Pkwy S.<br>Jacksonville, FL 32246 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Pam Martin, MSc, RAC<br>Regulatory Affairs Project Manager<br>Phone: 800-625-1557<br>Email: pmartin@klsmartin.com | | Alternate Contact: | Melissa Bachorski<br>Director of RA/QMS North America<br>Phone: 800-625-1557<br>Email: melissa.bachorski@klsmartin.com | | Date Prepared: | July 15, 2022 | | Trade Name: | KLS Martin Individual Patient Solutions | | Common Name: | System used to plan & fabricate patient-specific bone plates,<br>anatomical models, cutting/marking guides, splints, and case<br>reports | | Regulation Numbers: | 21 CFR 872.4760 | | Regulatory Class: | II | | Primary ProCode: | JEY | | Subsequent ProCodes: | DZJ, LLZ | | Primary Predicate: | KLS Martin Individual Patient Solutions (K191028) | | Reference Devices: | KLS Martin Mini Osteosynthesis System (K943347)<br>TruMatch CMF Titanium 3D Printed Implant (K170272)<br>KLS Martin IPS Planning System (K182789) | ### Device Description: KLS Martin Individual Patient Solutions (IPS) is comprised of a collection of software and associated additive manufacturing equipment intended to produce various outputs to support reconstructive and orthognathic surgeries. The system processes the medical images to produce various patient-specific physical and/or digital output devices which include implants, anatomical models, guides, splints, and case reports. Patient-specific metallic bone plates are used in conjunction with metallic bone screws for internal fixation of maxillofacial, midface, and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. There is a registered trademark symbol next to the word "martin". ### KLS-Martin L.P. Mail: P.O. Box 16369 · Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com the generated output device over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Implants are provided non-sterile and are manufactured using traditional (subtractive) or additive manufacturing methods from either CP Titanium (ASTM F67) or Ti-6AI-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws. # Indications for Use: KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery. KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age to < 12 years of age), adolescents (12 years of age - 21 years of age), and adults. # Technological Characteristics & Substantial Equivalence Discussion: The intended use of the subject device is identical to the primary predicate device, KLS Martin Individual Patient Solutions (K191028). The subject device differs from the primary predicate mainly in the target patient population and technological specifications. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing. # Similarities to Predicate & Reference Devices The subject and predicate devices are intended for reconstructive surgery in the facial skeleton and share the same fundamental principles of operation - Software is used to convert individual patient CT scans to digital models for subsequent surgical planning & fabrication of patient-specific devices for use in facial reconstructive surgery. The subject and predicate devices utilize image data obtained from a CT scan, which is input into validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from DICOM to. STL format and manipulate the images to produce a final design file. The subject devices are manufactured using identical methods and materials to those cleared in the primary predicate (K191028) and reference device (K182789), with the exception of the new splint material presented in this submission. The new splint material is discussed below in Splints. Both systems utilize additive manufacturing methods to produce physical output devices that include patient-specific implants, anatomical models, guides, and splints. In addition, the systems produce digital models and case reports for the physician to use for planning of maxillofacial surgeries or to use during surgery. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for KLS martin. The text "KLS" is in red, and the text "martin" is in gray. The registered trademark symbol is in the upper right corner of the word "martin". Below the words "KLS martin" is the word "GROUP" in gray. Surgical Innovation is Our Passion Mail: P.O. Box 16369 · Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy), which are identical to what was evaluated in the primary predicate device, K191028. The specifications for the subject device implants are similar to predicate K191028 with respect to plate style, thickness, width, length, degree of curvature, fixation hole spacing, and number of fixation holes. The titanium screws used to fixate the subject device plates range in diameter from 1.5 mm - 3.2 mm in lengths from - 22 mm, which are identical to the screws previously evaluated in K191028. The subject and predicate devices are provided non-sterile and require the end-user to process the devices using validated cleaning and sterilization methods prior to use as recommended in the device labeling. # Differences from Predicate & Reference Devices # Components & Indications for Use The primary predicate components include the planning software, implants, and anatomical models. The reference device (K182789) components include the planning software, anatomical models, cutting/marking guides, splints, and case reports. The subject device system combines all previously cleared components and indications for use into one system - planning software, implants, anatomical models, cutting/marking guides, splints, and case reports. # Target Population The primary predicate device, K191028, was cleared for the adult population. The purpose of this submission is to expand the patient population to include the following pediatric subpopulations: - . Children (2 years of age to < 12 years of age) - Adolescents (12 years of age 21 years of age) ● A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these subpopulations with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device implants for use in the target pediatric subpopulations. The reference device, K182789, was previously cleared for all pediatric subpopulations from neonate through adolescent to adult for all IPS components with the exception of permanent implants. The TruMatch CMF Titanium 3D Printed Implant (K170272) has been included as a reference device to support the use of permanent implants in the adolescent population. # Specifications The subject device dimensions differ from the predicate by offering additional device sizes to accommodate volumetric defects in facial reconstruction cases for the mandible. Previously cleared specifications for the K191028 predicate plate thickness for the mandibular region ranges from 1.0 mm - 3.0 mm. The subject device plates for the mandibular region differ by ranging in maximum thickness up to 10 mm. This expansion of the design envelope thickness for mandibular implants is supported by our previously cleared primary predicate maxillofacial / midface devices that were cleared for up to 10 mm in maximum thickness to accommodate volumetric defects. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. There is a registered trademark symbol next to the word "martin". Mail: P.O. Box 16369 · Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com Surgical Innovation is Our Passion The subject device also proposes two mandibular implant categories with distinct specifications based on type of mandible defect, continuity vs. non-continuity. Minimum thickness for mandible (non-continuity) & maxilla/midface defects is 0.6 mm and 2.0 mm for mandible continuity defects. Minimum thickness for orbital reconstruction is 0.3 mm. Mandible continuity defects are known to produce larger loads than non-continuity defects or maxillary implants, which is demonstrated by the larger reference device specifications in that situation. Maxillary defects are not subjected to the same loads and thus, subject devices in this area are not designed for dental loading unless supported by bone. Orbital implants are non-load bearing, other than supporting intraorbital contents. Responsible clinical conditions for volumetric defects include, but are not limited to, bone resection due to tumors or disease, blunt force trauma, facial defects, bone atrophy, and aesthetic augmentation for facial symmetry. Previously defined specifications for orbital implants in the K191028 predicate were limited to implant thickness, hole spacing, and number of holes. Additional specifications (width, length, and degree of curvature) have been defined for the subject devices in the orbital region to formulate a realistic worst-case construct, provide better control on design variations, and to parallel specifications for the midface and mandible regions. These new specification categories are more restrictive than in the K191028 predicate device and therefore, result in more controllable and mechanically stable design variations. Any differences in specifications between the subject and predicate devices have been addressed with mechanical bench testing performed on the new worst-case midface, orbit, and mandible plate designs to demonstrate that the design expansion does not raise new or different questions for the determination for substantial equivalence. The K943347 reference device includes traditionally manufactured (subtractive, milled) titanium plates of various sizes and shapes that range in thickness from 0.6 - 1.0 mm and are intended for the stabilization of bone in oral-maxillo-craniofacial surgery. Comparative performance testing and additional bench analysis has addressed any minor differences between the subject, primary predicate, and reference devices. ### Splints The subject device system includes splints additively manufactured from Ti-6Al-4V (ASTM F136:2013) via SLM methods. The subject device also includes splints additively manufactured from a light-cured resin photopolymer material. The photopolymer resin is composed of acrylate/methacrylate polymers and is manufactured using cDLM methods, which is similar in material composition and uses similar manufacturing methods as the acrylic/methacrylic resins used to fabricate splints from DLP methods previously evaluated under reference device K182789. A device comparison table of the subject, predicate, and reference devices is provided below: {7}------------------------------------------------ ### KLS-Martin L.P. Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com | | KLS Martin Individual Patient<br>Solutions | KLS Martin Individual Patient<br>Solutions<br>K191028 | KLS Martin IPS Planning System<br>K182789 | KLS Martin Mini Osteosynthesis<br>System (2.0mm)<br>K943347 | TruMatch CMF Titanium 3D<br>Printed Implant System<br>K170272 | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | | Indications for Use | KLS Martin Individual Patient Solutions<br>(IPS) is intended as a pre-operative<br>software tool for simulating / evaluating<br>surgical treatment options as a software<br>and image segmentation system for the<br>transfer of imaging information from a<br>medical scanner such as a CT based<br>system. The input data file is processed<br>by the IPS software and the result is an<br>output data file that may then be provided<br>as digital models or used as input in an<br>additive manufacturing portion of the<br>system that produces physical outputs<br>including implants, anatomical models,<br>guides, splints, and case reports for use in<br>maxillofacial, midface, & mandibular<br>surgery.<br>KLS Martin Individual Patient Solutions<br>(IPS) implant devices are intended for<br>use in the stabilization, fixation, and<br>reconstruction of the maxillofacial /<br>midface and mandibular skeletal regions<br>in children (2 years of age to < 12 years<br>of age), adolescents (12 years of age - 21<br>years of age), and adults. | KLS Martin<br>Individual Patient<br>Solutions implant devices are intended<br>for use in the stabilization, fixation, and<br>reconstruction of the maxillofacial /<br>midface and mandibular skeletal<br>regions. | The KLS Martin Individual Patient<br>Solutions (IPS) Planning System is<br>intended for use as a software system and<br>image segmentation system for the<br>transfer of imaging information from a<br>medical scanner such as a CT based<br>system. The input data file is processed<br>by the IPS Planning System and the result<br>is an output data file that may then be<br>provided as digital models or used as<br>input to a rapid prototyping portion of the<br>system that produces physical outputs<br>including anatomical models, guides,<br>splints, and case reports for use in<br>maxillofacial surgery. The IPS Planning<br>System is also intended as a pre-operative<br>software tool for simulating/ evaluating<br>surgical treatment options. | The KLS Martin Mini<br>Osteosynthesis System is intended<br>for use in the stabilization and<br>fixation of mandibular fractures and<br>oral-maxilla-cranio-facial surgery.<br>The bone segments are attached to<br>the plate with screws to prevent<br>movement of the segments. | The TruMatch CMF Titanium 3D<br>Printed Implant System is intended for<br>bone fixation, positioning and<br>reconstruction of the maxillofacial<br>skeleton, midface, mandible and chin<br>in adolescents (greater than 12 to 21<br>years of age) and adults.<br>Specific indications for use:<br>• Orthognathic surgery<br>• Reconstructive mandible and<br>maxillofacial surgery<br>• Mandible and maxillofacial<br>trauma surgery | | Patient-specific? | Yes, manufactured based on patient CT<br>scan | Yes, manufactured based on patient CT<br>scan | Yes, manufactured based on patient CT<br>scan | No. | Yes, manufactured based on patient<br>CT scan | | Classification | 21 CFR 872.4760, Class II | 21 CFR 872.4760, Class II | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 872.4760, Class II | 21 CFR 872.4760, Class II | | Product Code | JEY, DZJ, LLZ | JEY | DZJ, LLZ | JEY | JEY | | Anatomical Sites | Maxillofacial / Midface & Mandible | Maxillofacial / Midface & Mandible | Maxillofacial / Midface & Mandible | Craniomaxillofacial | Maxillofacial / Midface, Mandible &<br>Chin | | | KLS Martin Individual Patient<br>Solutions | KLS Martin Individual Patient<br>Solutions<br>K191028 | KLS Martin IPS Planning System<br>K182789 | KLS Martin Mini Osteosynthesis<br>System (2.0mm)<br>K943347 | TruMatch CMF Titanium 3D<br>Printed Implant System<br>K170272 | | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | | Material | • Anatomical Models: Epoxy/Acrylic<br>Resins<br>• Implants: CP Titanium or Ti-6Al-4V<br>• Cutting/Marking Guides: Polyamide,<br>Ti-6Al-4V, CP Titanium<br>• Splints:<br>acrylic/methacrylic/photopolymer<br>resins, Ti-6Al-4V | • Anatomical Models: Epoxy/Acrylic<br>Resins<br>• Implants: CP Titanium or Ti-6Al-4V | • Anatomical Models: Epoxy/Acrylic<br>Resins<br>• Cutting/Marking Guides: Polyamide,<br>Ti-6Al-4V, CP Titanium<br>• Splints: acrylic/methacrylic resins | • Implants: CP Titanium or<br>Ti-6Al-4V | • Implants: CP Titanium | | Manufacturing<br>Method | • Epoxy/Acrylic Resins: Additive;<br>Stereolithography (SLA)<br>• CP Titanium: Traditional<br>(Subtractive)<br>• Ti-6Al-4V: Additive; Selective Laser<br>Melting (SLM) & Traditional<br>(Subtractive)<br>• Acrylic/methacrylic resins (DLP)<br>• Photopolymer resins (cDLM) | • Epoxy/Acrylic Resins: Additive;<br>Stereolithography (SLA)<br>• CP Titanium: Traditional<br>(Subtractive)<br>• Ti-6Al-4V: Additive; Selective<br>Laser Melting (SLM) & Traditional<br>(Subtractive) | • Epoxy/Acrylic Resins: Additive;<br>Stereolithography (SLA)<br>• CP Titanium: Traditional<br>(Subtractive)<br>• Ti-6Al-4V: Additive; Selective Laser<br>Melting (SLM)<br>• Polyamide: Additive; Selective Laser<br>Sintering (SLS)<br>• Acrylic/methacrylic resins (DLP) | • Traditional (Subtractive –<br>Milling) | • CP Titanium: 3D Additive | | Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | | Target Population | • Children (2 years of age to < 12 years<br>of age)<br>• Adolescents (12 years of age – 21<br>years of age)<br>• Adults | • Adults | • Neonates (birth to 28 days)<br>• Infants (29 days to < 2 years of age<br>• Children (2 years of age to < 12 years<br>of age)<br>• Adolescents (12 years of age – 21<br>years of age)<br>• Adults | • Not specified | • Adolescents (12 years of age – 21<br>years of age)<br>• Adults | | | KLS Martin Individual Patient<br>Solutions<br>(Subject Device) | KLS Martin Individual Patient<br>Solutions<br>K191028<br>(Primary Predicate) | KLS Martin IPS Planning System<br>K182789<br>(Reference Device) | KLS Martin Mini Osteosynthesis<br>System (2.0mm)<br>K943347<br>(Reference Device) | TruMatch CMF Titanium 3D<br>Printed Implant System<br>K170272<br>(Reference Device) | | Thickness | • Orbital: 0.3 mm – 1.0 mm<br>• Maxillofacial / midface<br>reconstruction: 0.6 mm – 10 mm<br>• Mandibular reconstruction:<br>o 0.6 mm – 10 mm (Non-continuity<br>defects)<br>o 2.0 mm – 10 mm<br>(Continuity defects) | • Orbital: 0.3 mm – 1.0 mm<br>• Maxillofacial / midface<br>reconstruction:<br>o 0.6 mm – 10 mm<br>• Mandibular reconstruction:<br>o 1.0 mm – 3.0 mm | Not applicable | • 0.6 mm – 1.0 mm | Orthognathic applications:<br>• Maxillary fixation: 0.8 mm – 1.5 mm<br>• Mandibular fixation BSSO: 1 – 1.5 mm<br>• Mandibular fixation genioplasty: 0.8<br>mm – 1.5 mm<br>Reconstruction applications: Orbit<br>• Orbital fracture treatment: 0.8 mm – 1.2<br>mm<br>Reconstruction applications:<br>Mandible, Midface<br>• Mandibular reconstruction (small) /<br>mandibular bone fixation: 1.5 mm – 2<br>mm<br>• Mandibular reconstruction (large) /<br>mandibular bone fixation and<br>mandibular reconstruction with bone<br>grafts: 2 mm – 3 mm<br>• Midface reconstruction: 0.8 mm – 1.5<br>mm | | Style | Non-compression<br>Compression<br>Threaded | Non-compression<br>Compression<br>Threaded | Not applicable | Standard<br>Low profile | Multiple / various range of shapes | | Width<br>(Screw-hole<br>dependent) | Orbit:<br>Min: ≥ 3.5 mm (around screw holes)<br>Min: ≥ 2.2 mm (not around screw hole)<br>Maxillofacial / midface:<br>Min: ≥ 4.5 mm (around screw holes)<br>Min: ≥ 2.2 mm (not around screw hole)<br>Mandibular (continuity defect):<br>Min: ≥ 6.4 mm (around screw holes)<br>Min: ≥ 3.2 mm (not around screw hole)<br>Mandibular (non-continuity defect):<br>Min: ≥ 4.5 mm (around screw holes)<br>Min: ≥ 2.2 mm (not around screw hole) | Maxillofacial / midface:<br>Min: ≥ 4.5 mm (around screw holes)<br>Min: ≥ 3 mm (not around screw hole)<br>Max: Screw-hole dependent<br>Mandibular:<br>Min: 7 mm<br>Max: 8.5 mm | Not applicable | Not applicable | Unknown | {8}------------------------------------------------ ### KLS-Martin L.P. Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com {9}------------------------------------------------ ### KLS-Martin L.P. Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for KLS Martin Group. The letters "KLS" are in red, while "martin" and "GROUP" are in gray. A registered trademark symbol is located to the right of the word "martin." Mail: P.O. Box 16369 • Jacksonville, FL 32245-6369 Physical: 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246-7652 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com Surgical Innovation is Our Passion | | KLS Martin Individual Patient<br>Solutions | KLS Martin Individual Patient<br>Solutions<br>K191028 | KLS Martin IPS Planning System<br>K182789 | KLS Martin Mini Osteosynthesis<br>System (2.0mm)<br>K943347 | TruMatch CMF Titanium 3D<br>Printed Implant System<br>K170272 | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------| | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | | Length | Orbit:<br>Min: 10.5 mm<br>Max: 50 mm<br>Maxillofacial / midface:<br>Min 18 mm<br>Max: 350 mm<br>Mandibular (continuity defect):<br>Min: 25 mm<br>Max: 350 mm<br>Mandibular (non-continuity defect):<br>Min: 18 mm<br>Max: 350 mm | Maxillofacial / midface:<br>Min: 18 mm<br>Max: 350 mm<br>Mandibular:<br>Min: 31 mm<br>Max: 320 mm | Not applicable | Not applicable | Min: 20 mm<br>Max: 294 mm | | Degree of curvature<br>(In-plane) | Orbital, Mandibular, Maxillofacial /<br>Midface:<br>Min: 30°<br>Max: 180° | Maxillofacial / midface:<br>Min: 30°<br>Max: 180°<br>Mandibular:<br>Min: 90°<br>Max: 180° | Not applicable | Not applicable | Unknown | | Degree of curvature<br>(Out-of- plane) | Orbital, Mandibular, Maxillofacial /<br>Midface:<br>Min: 15°<br>Max: 180° | Maxillofacial / midface:<br>Min: 15°<br>Max: 180°<br>Mandibular:<br>Min: 60°<br>Max: 180° | Not applicable | Not applicable | Unknown | | Hole spacing | Orbit:<br>>=3.5 mm<br>Maxillofacial / midface:<br>>=4.5 mm<br>Mandibular:<br>>=4.5 mm<br>(non-continuity defect)<br>>=6.4 mm (continuity defect) | Orbital & Maxillofacial / midface:<br>>=4.5 mm<br>Mandibular:<br>>=8 mm | Not applicable | Not applicable…