What is the regulatory pathway for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

Q: Who is the manufacturer of Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

Materialise NV filed the 510(k) submission for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637).

Q: What is the FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

DZJ. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

K243637 · Materialise NV · DZJ · Feb 21, 2025 · Dental

Device Facts

Record ID	K243637
Device Name	Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Applicant	Materialise NV
Product Code	DZJ · Dental
Decision Date	Feb 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4120
Device Class	Class 2
Attributes	Pediatric

Intended Use

Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications. CMF Titanium Guides are intended for children, adolescents and adults. CMF Titanium Guides are intended for single use only. CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery. Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures. CMF Plastic Models are intended for infants, children, adolescents and adults. CMF Plastic Models are intended for single use only. CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Device Story

Device system uses 3D preoperative planning software to convert patient medical images (CT) into 3D anatomical representations. Surgeon provides instructions to simulate treatment; system designs patient-matched titanium guides and plastic models. Guides facilitate bone marking and surgical instrument positioning; models assist in visualization, surgical preparation, and implant fitting. Used in OR by maxillofacial surgeons. Devices manufactured via additive manufacturing (Selective Laser Melting for titanium; Stereolithography or Selective Laser Sintering for plastics). Provided non-sterile; require hospital-based steam sterilization. Output enables precise transfer of preoperative plans to surgical site, potentially improving surgical accuracy and simplifying complex craniomaxillofacial interventions.

Clinical Evidence

Bench testing only. Includes mechanical verification, compatibility testing with screw systems, biocompatibility (ISO 10993), and sterilization validation (ISO 17665-1). Pediatric safety supported by risk mitigation assessment per FDA guidance and peer-reviewed clinical data on similar devices.

Technological Characteristics

Materials: Commercially pure Titanium, Polyamide, Clear acrylic. Manufacturing: Additive (Selective Laser Melting, Stereolithography, Selective Laser Sintering). Sterilization: Pre-vacuum steam. Connectivity: Software-based planning system. Design: Patient-matched, mesh or solid-pattern, 0.8mm thickness for titanium guides.

Indications for Use

Indicated for infants (models only), children, adolescents, and adults undergoing facial, mandibular, or maxillofacial surgical procedures, including orthognathic surgery, bone reconstruction, and bone harvesting.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

KLS Martin Individual Patient Solutions (IPS) Planning System (K182789)

Reference Devices

TruMatch CMF Titanium 3D Printed Implant (K173039)
TruMatch CMF 3D Printed Implant System (K170272)
SurgiCase Guide (K111558)
SurgiCase Guide (K103136)
KLS Martin Individual Patient Solutions (K210731)

Related Devices

K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models · Materialise NV · Jan 7, 2026
K181241 — KLS Martin Individual Patient Solutions (IPS) Planning System · KLS-Martin L.P. · Sep 13, 2018
K210731 — KLS Martin Individual Patient Solutions · KLS-Martin L.P. · Jul 18, 2022
K211614 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System · Centermed, Inc. · Aug 4, 2022
K210347 — VSP System · 3D Systems · Apr 26, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Materialise NV Polliane Carvalho Regulatory Affairs Specialist Technologielaan 15 Leuven, 3001 BELGIUM February 21, 2025 Re: K243637 Trade/Device Name: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: November 25, 2024 Received: November 25, 2024 Dear Polliane Carvalho: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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). {2}------------------------------------------------ Sincerely, Sherrill Lathrop Blitzer 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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K243637 Device Name Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Indications for Use (Describe) Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications. CMF Titanium Guides are intended for children, adolescents and adults. CMF Titanium Guides are intended for single use only. CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery. Materialise Personalized Models for Craniomaxillofacial Surgery Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures. CMF Plastic Models are intended for infants, children, adolescents and adults. CMF Plastic Models are intended for single use only. CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-----------------------------------------------| | ☑ 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." {4}------------------------------------------------ # 510(k) summary The 510(k) summary is provided on the following page per 21 CFR 807.92(c). #### 510(k) summary The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92 ### Submitter information | Company name | Materialise NV | |-----------------------------------|----------------------------------------------| | Establishment registration number | 3003998208 | | Street Address | Technologielaan 15 | | City | Leuven | | Zip code | 3001 | | Country | Belgium | | Phone number | +32 16 74 49 56 | | Fax number | +32 16 39 66 00 | | Principal contact person | Polliane Carvalho | | Contact title | Regulatory Affairs Specialist | | Contact e-mail address | polliane.carvalho@materialise.com | | Additional contact person | Jenny Jones | | Contact title | Global Quality & Regulatory Manager, Medical | | Contact e-mail address | jenny.jones@materialise.com | #### Submission date Date of the Traditional 510(k) submission is February 10, 2025 ### Submission information | Trade name | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | |------------------------------------------|-------------------------------------------------------------------------------| | Common or Usual name | CMF Titanium Guides CMF Plastic Models | | Classification name | Bone cutting instrument and accessories | | Product code (classification regulation) | Primary product code: DZJ Secondary product code: LLZ | | Classification Panel | Dental | | Device class | 21 CFR 872.4120, Class II | # Predicate device {5}------------------------------------------------ The predicate device to which substantial equivalence is claimed to: | KLS Martin Individual Patient Solutions (IPS) Planning System | | | |---------------------------------------------------------------|--------------------------------------------------------|--| | Trade or proprietary or model name | KLS Martin Individual Patient Solutions (IPS) Planning | | | | System | | | 510(k) number | K182789 | | | Decision date | 03/11/2019 | | | Product code | DZJ (21 CFR 872.4120) | | | Manufacturer | KLS Martin | | | Review Panel | Dental | | # Reference devices | TruMatch CMF Titanium 3D Printed Implant | | | |------------------------------------------|------------------------------------------|--| | Trade or proprietary or model name | TruMatch CMF Titanium 3D Printed Implant | | | 510(k) number | K173039 | | | Decision date | 07/10/2018 | | | Product code | JEY (21 CFR 872.4760) | | | Manufacturer | Materialise | | | Review Panel | Dental | | | TruMatch CMF 3D Printed Implant System | | |----------------------------------------|----------------------------------------| | Trade or proprietary or model name | TruMatch CMF 3D Printed Implant System | | 510(k) number | K170272 | | Decision date | 08/08/2017 | | Product code | JEY (21 CFR 872.4760) | | Manufacturer | Materialise | | Review Panel | Dental | | SurgiCase Guide (cranial Application) | | |---------------------------------------|-----------------------| | Trade or proprietary or model name | SurgiCase Guide | | 510(k) number | K111558 | | Decision date | 03/27/2012 | | Product code | HAW (21 CFR 882.4560) | | Manufacturer | Materialise | | Review Panel | Neurology | | SurgiCase Guide (mandibular and maxillofacial application) | | |------------------------------------------------------------|---------------------------------------------------------------------| | Trade or proprietary or model name | SurgiCase Guide (SurgiCase CMF, SurgiCase Connect, SurgiCase Guide) | | 510(k) number | K103136 | | Decision date | 03/18/2011 | | Product code | JEY (21 CFR 872.4760) | | Manufacturer | Materialise | | Review Panel | Dental | {6}------------------------------------------------ | KLS Martin Individual Patient Solutions | | |-----------------------------------------|--------------------------------------------------| | Trade or proprietary or model name | KLS Martin Individual Patient Solutions | | 510(k) number | K210731 | | Decision date | 07/18/2022 | | Product code | JEY (21 CFR 872.4760), DZJ(21 CFR 872.4120), LLZ | | Manufacturer | KLS Martin | | Review Panel | Dental | ### Indications for use #### Materialise Personalized Guides and Models for Craniomaxillofacial Surgery #### Materialise Personalised Guides for Craniomaxillofacial Surgery Materialise Personalised Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications. CMF Titanium Guides are intended for children, adolescents and adults. CMF Titanium Guides are intended for single use only. CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery. #### Materialise Personalized Models for Craniomaxillofacial Surgery Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures. CMF Plastic Models are intended for infants, children, adolescents and adults. CMF Plastic Models are intended for single use only. CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery. ### Device Description Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries. The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models. {7}------------------------------------------------ | Manufacturing | Additive manufacturing - Selective Laser Melting | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Commercially pure Titanium | | Sterilization | Pre-vacuum steam sterilization at the hospital | | Style | Mesh-shaped, contoured to patient's anatomy | | Thickness | 0.8 mm | | Maximal guide length | 94.2 mm for guides with solid-pattern links 104.2 mm for guides with mesh-pattern links 400 mm for bone graft harvesting guides | | Minimal number of teeth used for support | 4 teeth (2 on each side) for full arch 2 teeth for partial arch | | Pre-drilling barrels | Guidance of drill - Min height is 3.0 mm - Inner diameter equals drill diameter + 0.05mm Guidance of drill sleeve (DePuy Synthes ref 03.503.045) - Min height is 5.0 mm - Inner diameter is 3.57 mm | | Fixation holes | Inner diameter - 2.2 or 2.7 mm for MatrixMANDIBLE screw - 2.1 mm for MatrixORTHOGNATHIC screw - 1.9 mm for MatrixMIDFACE screw Countersink diameter - 4.0 mm for MatrixMANDIBLE screw - 3.5 mm for MatrixORTHOGNATHIC & MatrixMIDFACE screw | | Features | - Marking cylinders - Flanges - Cutting slot - Handle - Label | The main parameters for the CMF Titanium Guides are summarized below. The main parameters for the CMF Plastic Models are summarized below. | Manufacturing | Additive manufacturing – Selective Laser Sintering (SLS) or Stereolithography (SLA) | |---------------|----------------------------------------------------------------------------------------| | Material | Polyamide or Clear acrylic | {8}------------------------------------------------ | Sterilization | Pre-vacuum steam sterilization at the hospital | |---------------|------------------------------------------------| | Style | Solid or hollow | ### Substantial Equivalence Comparison Indications for Use #### Similarities to Predicate & Reference Devices The subject device (K243637), the predicate (K182789), and reference devices K173039, K170272, K111558, K103136, K210731) are intended to be used in the facial skeleton or maxillofacial surgeries. subject and predicate devices are patient specific devices used during The bone repositioning/reconstruction surgical operations for orthognathic and reconstruction indications. The subject device CMF Titanium Guides are included in predicate (K182789) and reference devices (K173039, K170272, and K210731). The subject device CMF Plastic Models is included in the predicate (K182789) and reference device (K210731). The subject devices (CMF Titanium Guides) and the reference device (K170272) are both indicated for adolescents and adult populations. The subject devices (CMF Titanium Guides and CMF Plastic Models) and the predicate (K182789) and reference devices (K210731 CMF Titanium Guides and CMF Models) are both indicated for children, adolescents, and adult populations. #### Differences to Predicate & Reference Devices The subject device (CMF Titanium Guides) expands the target population to include children from the reference devices (K173039 and K170272) which were cleared for adolescents and adult populations. The subject device (CMF Plastic Models) expands the target population from reference device (K210731) to include infants. To demonstrate the safety and effectiveness of the subject device in the pediatric population, a risk mitigation assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for the target pediations. This risk assessment, in combination with the peer-reviewed clinical data on the subject devices, supports the safe and effective use of the subject device in pediatric patients. The potential impact on the substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing. ### Substantial Equivalence Comparison Technological Characteristics #### Similarities to Predicate & Reference Devices The subject devices (K243637) and the predicate (K182789), and reference devices (K173039, K170272, K111558, K103136, K210731) share the same principles of operation where software is used to convert individual patient medical images to virtual models for surgical planning and design and fabrication of patient-specific devices for use in craniomaxillofacial surgery. {9}------------------------------------------------ The subject devices (K243637) and the predicate (K182789), and reference devices (K173039, K170272, K111558, K103136, K210731) use additive manufacturing methods to produce physical output devices. The subject device (CMF Titanium Guides), predicate device (K182789) and reference devices (K173039, K170272 and K210731) are produced with the additive manufacturing technology Selective Laser Melting (SLM). The subject device (CMF Titanium Guides) and the predicate device (K182789) can both be made of commercially pure Titanium as material. The subject device (CMF Plastic Models), the predicate device (K182789) and reference device (K210731) are produced with the additive manufacturing technology Stereolithography (SLA) using Acrylic Resin. The subject device (CMF Plastic Models) and the predicate device are also produced with an additional additive manufacturing technology Selective Laser sintering with Polyamide. The subject devices are manufactured using identical methods to those cleared in the primary predicate (K182789) and reference devices (K173039, K170272, K111558, K103136). The subject, predicate, and reference 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 instructions for use. #### Differences to Predicate & Reference Devices: The subject device is limited to the use of 3D pre-operative planning software with patient-matched guides and models, while the predicate and reference devices collectively combine the use of 3D pre-operative planning software with patient-matched implants, plates, models and splints to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Any differences in specifications between the subject and predicate devices have been covered by worst case design tests performed to demonstrate that the design expansion does not raise new or different questions for the determination for substantial equivalence. The subject device (CMF Titanium guides) is not produced through traditional (subtractive) manufacturing as is the case for the Cutting/Marking Guides in CP Titanium of the predicate device (K182789). The subject device (CMF Plastic Models) is also produced with an additive manufacturing technology Selective Laser Sintering with Polyamide whereas for the reference devices (K111558, K103136, K210731) CMF Guides are produced with this technology/material. A device comparison table of the subject, predicate, and reference devices is provided below. {10}------------------------------------------------ | Characterist | Subject device | Predicate device | Reference device | Reference device | Reference devices | Reference device | |---------------|--------------------------------------------------|------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------|----------------------------------------------------| | ic | Materialise | KLS Martin IPS | TruMatch CMF | TruMatch CMF 3D | - SurgiCase Guide | KLS Martin Individual | | | Personalized Guides | Planning System | Titanium 3D Printed | Printed Implant | (K111558) | Patient Solutions | | | and Models for | (K182789) | Implant (K173039) | System (K170272) | - SurgiCase Guide | (K210731) | | | Craniomaxillofacial | | | | (SurgiCase CMF, | | | | Surgery | | | | SurgiCase Connect, | | | | | | | | SurgiCase Guide) | | | | | | | | (K103136) | | | Product | DZJ, LLZ | DZJ, LLZ | JEY | JEY | HAW | JEY, DZJ, LLZ | | code | | | | | | | | Classificatio | 21 CFR 872 4120, Class II | 21 CFR 872 4120, Class II | 21 CFR 872 4760, Class II | 21 CFR 872 4760, Class II | 21 CFR 882.4560, Class II | 21 CFR 872 4760, Class II | | n | | | | | | | | Indications | Materialise Personalized | The KLS Martin Individual | TruMatch The CMF | The TruMatch CMF | SurgiCase Guides are | KLS Individual | | for Use | Guides and Models for | Patient Solutions (IPS) | 3D Printed Titanium | Printed Titanium 3D | intended to be used as | Patient Solutions (IPS) is | | | Craniomaxillofacial | System ાં ર Planning | Implant is a Patient | System ાટ Implant | surgical tools to transfer | intended as a pre- | | | Surgery | for use as a intended | Specific Implant and is | for bone intended | a pre-operative plan to | operative software tool | | | | system and software | for intended bone | repositioning, fixation | the surgery. The devices | simulating tor | | | Materialise Personalized | segmentation ımage | reconstruction, | and reconstruction of the | are intended to guide the | evaluating surgical | | | Guides tor Craniomaxillofacial | system for the transfer of imaging information | restoration of bone volumetric defects and | maxillofacial skeleton, midface, mandible and | marking of bone and/or guide surgical | treatment options as a software and image | | | Surgery | from a medical scanner | of increase the | chin in adolescents | instruments during | segmentation system for | | | Materialise Personalized | such as a CT based | mandibular and facial | (greater than 12 to 21 | craniofacial osteotomies. | the transfer of imaging | | | Guides tor | system. The input data | bones. The TruMatch | years of age) and adults. | The principal difference | information trom a | | | Craniomaxillofacial | file is processed by the | CMF Titanium 3D printed | Specific indications for | between the subject and | medical scanner such as a | | | Surgery are intended to | IPS Planning System and | implant is indicated for | use: | predicate device is with | CT based system. The | | | guide the marking of | the result is an output | non-load bearing | - Orthognathic Surgery | respect to the anatomical | file data ાંટ input | | | and/or guide bone | data file that may then be | applications. | - Reconstructive | region where the guides | ાંખર processed by the | | | surgical instruments in | provided digital વર | | mandible and | be will applied | software and the result is | | | facial surgery. | models or used as input | | maxillofacial surgery | craniofacial tor the | an output data file that | | | CMF Titanium Guides are | to a rapid prototyping | | Mandible and | subject guides versus | may then be provided as | | | during used bone | portion of the system | | maxillofacial trauma | mandibular and maxillary | digital models or used as | | | repositioning/reconstruc | that produces physical | | surgery | for the predicate guides. | input in an additive | | | tion surgical operations for orthognathic and | outputs including | | | SurgiCase Guides are intended for single use | manufacturing portion of | | | reconstruction (including | anatomical models, guides, splints, and case | | | only. | the system that produces physical outputs | | | bone harvesting) | reports tor use in | | | | including implants, | | | indications. | maxillofacial surgery. The | | | | anatomical models, | | | | IPS Planning System is | | | | guides, splints, and case | | | | also intended as a pre- | | | | in for reports use | {11}------------------------------------------------ | CMF Titanium Guides are | operative software tool | | maxillofacial, midface, & | |--------------------------------------------------|-------------------------|--|-----------------------------| | intended for children, | simulating/ for | | mandibular surgery. | | adolescents and adults. | evaluating surgical | | KLS Martin Individual | | CMF Titanium Guides are | treatment options. | | Patient Solutions (IPS) | | intended for single use | | | implant devices are | | only. | | | intended for use in the | | CMF Titanium Guides are | | | stabilization, fixation, | | to be used by a physician | | | and reconstruction of the | | in the trained | | | maxillofacial / midface | | of performance | | | and mandibular skeletal | | maxillofacial surgery. | | | regions in children (2 | | | | | years of age to < 12 years | | Materialise Personalized | | | of age), adolescents (12 | | Models for | | | years of age - 21 years of | | Craniomaxillofacial | | | age), and adults. | | | | | | | Surgery | | | | | Materialise Personalized | | | | | Models for Craniomaxillofacial | | | | | | | | | | Surgery are intended for | | | | | visualization of the | | | | | patient's anatomy, preparation of surgical | | | | | | | | | | interventions and fitting | | | | | adjustment of or or | | | | | implants or other medical | | | | | devices such વર | | | | | osteosynthesis plates or | | | | | in distractors, | | | | | mandibular and | | | | | maxillofacial surgical | | | | | procedures. | | | | | CMF Plastic Models are | | | | | intended for infants, | | | | | children, adolescents and | | | | | adults. | | | | | CMF Plastic Models are | | | | | intended for single use | | | | | only. | | | | | CMF Plastic Models are | | | | | to be used by a physician | | | | | trained in the | | | | {12}------------------------------------------------ | performance of maxillofacial surgery. | | | | | | | |---------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Devices | CMF Titanium Guides and CMF Plastic Models | Anatomical Models Cutting/Marking Guides Splints | CMF Implants, Guides | CMF Plates, Guides | CMF Guides | CMF Implants, Guides, Models, Splints | | Target Population | • Infant (CMF Models only) • Children • Adolescents • Adults | Pediatric and Adults | Adults | Adolescents and adults | Adults | Children, adolescents and adults. | | Principles of Operation | Medical images used to plan surgery and design patient matched devices | Medical images used to plan surgery and design patient matched devices | Medical images used to plan surgery and design patient matched devices | Medical images used to plan surgery and design patient matched devices | Medical images used to plan surgery and design patient matched devices | Medical images used to plan surgery and design patient matched devices | | Manufacturi ng | Additive manufacturing | Traditional and Additive manufacturing • Epoxy/Resin, Acrylic: Stereolithography (SLA) • CP Titanium: Traditional (Subtractive) • Ti-6Al-4V: 3D (Additive; Selective Laser Melting) • Polyamide: 3D (Additive; Selective Laser Sintering) | Additive manufacturing | Additive manufacturing | Additive manufacturing | • Epoxy/Acrylic Resins: Additive; Stereolithography (SLA) • CP Titanium: Traditional (Subtractive) • Ti-6Al-4V: Additive; Selective Laser Melting (SLM) & Traditional (Subtractive) • Acrylic/methacrylic resins (DLP) • Photopolymer resins (cDLM) | | Material(s) | CMF Titanium Guides: Commercially Pure CMF Plastic Models: Acrylic resin, Polyamide | • Anatomical Models: Epoxy/Acrylic Resins • Cutting/Marking Guides: Polyamide, Titanium alloy (Ti-6Al- 4V), CP Titanium • Splints: methacrylate | Commercially Pure Titanium | Commercially Pure Titanium | Polyamide | • Anatomical Models: Epoxy/Acrylic Resins • Cutting/Marking Guides: Polyamide, Ti- 6Al-4V, CP Titanium | | Sterilization | Non-sterile (Pre-vacuum steam Sterilization) | Non-sterile (Steam) | Non-sterile (Pre-vacuum steam Sterilization) | Non-sterile (Moist heat) | Non-sterile (Moist heat) | Non-sterile (Steam) | {13}------------------------------------------------ # Substantial Equivalence Comparison Performance Data The following non-clinical testing was conducted as a basis for the determination of substantial equivalence: | Device | Name | Test method | Conclusion | |---------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CMF Titanium Guides | Compatibility testing | Bench test with surgeons to verify compatibility of CMF Titanium Guides with Synthes Matrix screws and Materialise Standard+ Solutions screws and instrumentation | The CMF Titanium devices are compatible with the DePuy Synthes MatrixNEURO, MatrixMIDFACE, MatrixORTHOGNATHIC, MatrixMANDIBLE systems and Materialise Standard+ Solutions screws and instrumentation. | | CMF Titanium Guides | Shape specification | The necessary geometrical accuracy of a CMF Titanium Guide for a surgeon to be comfortable with implanting a manually bent bone fixation plate | Bench tests with surgeons successfully demonstrated the necessary geometrical accuracy. | | CMF Titanium Guides | Mechanical verification | The CMF Titanium Guides should be resistant to stresses applied during surgery. No guide specific mechanical testing is performed but this is covered by mechanical analysis of CMF Titanium Plates. Note: CMF Titanium Plates are leveraged devices for information purposes only and not subject to this K243637 submission. | Analysis and testing demonstrated the mechanical performance of the CMF Titanium Guides. | | CMF Titanium Guides | Pediatric fit testing & useful life determination | The useful life of the CMF Titanium Guides was verified | The useful life of the CMF devices is found to be mainly exceeding 6 months | | Device | Name | Test method | Conclusion | |----------------------------------------------|-------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CMF Polyamide and Clear Acrylic Models | Resistance to handling forces during surgery | Use during validation activities | There are no expected handling forces exerted onto the models during use. Where models were available during the various Sawbones and cadaveric validation activities, none were reported to have deformed or broken during use. | {14}------------------------------------------------ # Biocompatibility: | Device | Test method | Conclusion | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | CMF Titanium Guides | Cytotoxicity: ● ISO 10993-5: Tests for in-vitro cytotoxicity - L929 Neutral red uptake Cytotoxicity | The result showed non- cytotoxicity. | | | ● Sensitization: ISO 10993-10: Tests for irritation and delayed-type hypersensitivity - Kligman Maximization test | The result showed non- sensitizer | | | Intra-cutaneous reactivity: ● ISO 10993-10: Tests for irritation and delayed-type hypersensitivity - Intra-cutaneous Injection Test | The result showed non- irritant. | | | Chemical characterization: ● ISO10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials (2005) | The risk of toxicity is considered to be low. | | | Assessment of allowable limits for leachable substances: ● ISO 10993-17 (2009) "Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances" | No toxicological concern remains further biological testing are considered not justified. | | | Pyrogenicity ISO 10993-11: 2006 | According to EP: The result showed no-pyrogenicity According to USP: The result showed non-pyrogenicity. | | Device | Test method | Conclusion | |-----------------------|-------------------------------------------|--------------------------------------------------------------------------------------------------| | CMF Plastic Models | Biocompatibility assessment per ISO 10993 | The CMF Plastic Models are evaluated and safe for use with respect to biocompatibility. | The sterilization testing is similar for all devices. | Device | Test method | Conclusion | |--------------|--------------------------------|---------------------------------------------------------------------| | CMF Titanium | Steam sterilization validation | The results of the steam sterilization validation show that the CMF | | Guides | according to ISO 17665- | Titanium Guides can be sterilized to a SAL of 10th using the | | | 1:2006, | recommended steam sterilization instructions | | CMF Plastic | Steam sterilization validation | The results of the steam sterilization validation show that the CMF | | Models | according to ISO 17665- | Plastic Models can be sterilized to a SAL of 10° using the | | | 1:2006, | recommended steam sterilization instructions | # Performance Data Clinical To demonstrate the safety and effectiveness of the subject device in the pediatric population, a risk mitigation assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for the target pediatric populations. This risk assessment in combination with the peer-reviewed clinical data on the subject device and similar devices, support the safe and effective use of the subject device in pediatric patients. {15}------------------------------------------------ ### Substantial Equivalence Performance Conclusion The non-clinical performance testing indicates that the subject device is substantially equivalent to the predicate device and reference devices. - Mechanical testing was performed using standard laboratory test methods and compared to the . reference devices. - . Compatibility with screw system was demonstrated. - . Biocompatibility was demonstrated as per standards. - . Sterilization validation was conducted.