Materialise TKA Guide System

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July 5, 2022 Materialise NV Jenny Jones Global Ouality and Regulatory Manager Technologielaan 15 Leuven, 3001 Belgium Re: K221337 Trade/Device Name: Materialise TKA Guide System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG, MBH Dated: May 6, 2022 Received: May 9, 2022 Dear Jenny Jones: 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. 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Sincerely, Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221337 Device Name Materialise TKA Guide System # Indications for Use (Describe) Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components. Hardware · Pin Placement Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting. The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. The Materialise TKA Guides are intended for single use only. # • Cut-Through Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting of the bone. The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System. Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System and AGC® Complete Knee system prostheses families only The Materialise TKA Guides are intended for single use only. # • Models The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components. The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho {3}------------------------------------------------ Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. The Materialise TKA Models are intended for single use only. Software The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | # 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." {4}------------------------------------------------ # 510(k) Summary The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92 | Company name | Materialise N.V. | |-----------------------------------|-----------------------------------| | Establishment registration number | 3003998208 | | Street Address | Technologielaan 15 | | City | Leuven | | Postal code | 3001 | | Country | Belgium | | Phone number | +32 16 39 66 11 | | Fax number | +32 16 39 66 06 | | Principal contact person | Jenny Jones | | Phone number | 734-259-7017 | | Contact title | Global Quality Regulatory Manager | | Contact e-mail address | Regulatory.Affairs@materialise.be | | Additional contact person | Ilke Vanhaelen | | Contact title | Device Development Engineer | | Contact e-mail address | ilke.vanhaelen@materialise.be | ### Submission date The date of the Traditional 510(k) submission is May 06, 2022. # Submission information | Trade Name | Materialise TKA Guide System | |--------------------------|-------------------------------------------------------------------------------------------------| | Common Name | Total knee replacement system with 3D planning software and<br>patient specific instrumentation | | Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-<br>constrained cemented prosthesis | | Primary product code | JWH (21 CFR 888.3560) | | Subsequent product codes | OIY, OOG, MBH | # Predicate Devices The predicate devices to which substantial equivalence is claimed: {5}------------------------------------------------ | Trade or proprietary or model name | Materialise TKA Guide System | |------------------------------------|------------------------------| | 510(k) number | K173445 | | Decision date | February 2, 2018 | | Classification product code | JWH (21 CFR 888.3560) | | Subsequent product codes | MBH, OIY, OOG | | Manufacturer | Materialise N.V. | The reference devices used to support a determination of substantial equivalence: | Trade or proprietary or model name | Materialise PKA Guide System | |------------------------------------|------------------------------| | 510(k) number | K202207 | | Decision date | October 02, 2020 | | Classification product code | HSX (21CFR888.3520) | | Manufacturer | Materialise N.V. | #### Device Description The Materialise TKA guide system is a medical device designed to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a pre-surgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery. The subject device is a system that consists of the following two functional components: - l A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical TKA plan for a specific patient. - Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis). {6}------------------------------------------------ #### Indications for use Note: indications for use differ from the predicate device because the compatible knee systems are the indications for use statement clarifies use of the models and software. Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components. #### Hardware - Pin Placement Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting. The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. The Materialise TKA Guides are intended for single use only. - Cut-Through Guides The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone. The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System and AGC® Complete Knee system prostheses families only The Materialise TKA Guides are intended for single use only. - Models The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components. The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only. {7}------------------------------------------------ The Materialise TKA Models are intended for single use only. #### Software The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models. #### Functioning of the Device The Materialise TKA Guide System generates a pre-surgical plan based on MRI or CT images using the SurgiCase Knee Planner. The SurgiCase Knee Planner then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise TKA Guides and Models are optional) are designed and manufactured based on the approved pre-surgical plan. Moterialise TKA Guides are patient-specific templates which transfer the pre-operatively determined positioning of the chosen total knee replacement components to the patient intra-operatively, assisting the surgeon in positioning the actual total knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room. #### Technological Characteristics A detailed comparison shows the Materialise TKA Guide System is substantially equivalent in intended use, design, functionality, operating principles, materials, performance characteristics and the same fundamental scientific technology to the predicate device. The Materialise TKA Guide System has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for simulation and planning of pre-operational intervention, and for positioning knee components, i.e., tibia and femur components (same as the predicate device and reference device). The subject device's hardware is intended for positioning knee components intra-operatively and in guiding the marking of bone before cutting of the bone (same as the predicate device). #### Software The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include: - Device functionality: The planning functionality, visualization options and planning features are the same for the knee planning of the subject device as for the predicate device. - Software technology: The subject device has the same code base as the predicate device and uses exact the same methods for design and verification as the predicate device. Following technological differences exist between the subject device software and the predicate device software. The main difference between the subject device and previously cleared predicate device K173445 is the addition of Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and {8}------------------------------------------------ Ortho Development BKS TriMax PS implants and instruments in the software component of the subject device for the surgeon to select during the planning stage. The subject software technology differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate device. #### Hardware The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, raw materials, and performance characteristics to the predicate device K173445. The main difference between the subject device and previously cleared predicate device K173445 includes: the addition of Materialise TKA Guides and Models that are compatible with the Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS implants and instruments. This resulted in the update of non-critical features of the Materialise TKA guides and models that will be used for this system. #### Performance Data (non-clinical) #### Hardware Previous testing for debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are similar as that of the predicate device, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing are considered applicable to the subject device. Although no additional tests in comparison with the predicate device testing were required to support substantial equivalence, new biocompatibility, end-user cleaning, sterilization, and packaging testing have been done for other reasons as explained below. - -Biocompatibility re-evaluation according to ISO 10993-1:2018 was done. The subject device was shown to be non-cytotoxic, non-sensitizing, non-irritant, non-systematically toxic (acute) and nonpyrogenic. - -End-user cleaning re-evaluation was done on extended cleaning cycle specifications, including testing of both manual and automated cleaning cycle with both enzymatic and alkaline detergent on a new worst-case design. All samples passed the cleaning test, validating the updated cleaning parameters. - । Sterilization re-evaluation using an overkill method total cycle in accordance with ISO 17665-1:2006 on a new worst-case design. All samples passed the sterilization test, validating the applied sterilization parameters for the subject device. - -Packaging testing for the added packaging configuration according to ISO 11607-1:2019 according to ISTA 3A:2018 and simulated distribution in accordance with ASTM D4169-16. Samples passed the packaging testing, demonstrating that new packaging configuration meets approved requirements, allowing to effectively and safely ship the subject device, based on the validation performed on the specifications for the packaging applied. {9}------------------------------------------------ ### Software Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs. #### Summary The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Materialise TKA System is substantial equivalent to the predicate device.