Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. September 12, 2023 Materialise NV Giulia Girola Regulatory Affairs Specialist Technologielaan 15 Leuven, 3001 Belgium Re: K231112 Trade/Device Name: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OHE, KWS, PHX Dated: July 7, 2023 Received: July 7, 2023 Dear Giulia Girola: 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. Thomas Mcnamara -S Digitally signed by Thomas Mcnamara -S Date: 2023.09.12 15:07:59 -04'00" For: Farzana Sharmin, 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) #### K231112 Device Name Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner ### Indications for Use (Describe) Hardware The Materialise Shoulder Guide and Models are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder - implants systems and their respective compatible components: - · Depuy Synthes' - GLOBAL® APG+ Shoulder System (K052472) - DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, K203694) - GLOBAL® STEPTECH® APG Shoulder System (K092122) - INHANCE™ Anatomic Shoulder System (K202716)1 - INHANCE™ Reverse Shoulder System (K212737) - · Enovis'2 (DJO) - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - Turon® Shoulder System (K080402) - AltiVate™ Anatomic Shoulder System (K162024) - AltiVate™ Anatomic Augmented Glenoid (K213387) - · Smith+Nephew's 3 - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - Lima's - SMR™ Shoulder System (K100858) - SMRTM Reverse Shoulder System (K110598) - SMRTM Modular Glenoid (K113254) (K143256) - SMR™ 3-Pegs Glenoid (K130642) - SMR™ TT Metal Back Glenoid (K133349) - SMRTM 40mm Glenosphere (K142139) - SMRTM TT Augmented 360 Baseplate (K220792) - SMR™ TT Hybrid Glenoid (K220792) - · Stryker's - ReUnion RSA Reverse Shoulder System (K183039) - Reunion TSA Total Shoulder Arthroplasty System (K183039) ## Software SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 can be used as input data to design the Materialise Shoulder Guide and Models. ¹ The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System. {3}------------------------------------------------ | 2 DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical). | |-----------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------------| 3 The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew. 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 following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.18 | 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 | | Primary contact person | Giulia Girola | | Phone number | +39 3285339108 | | Contact title | Regulatory Affairs Specialist | | Contact e-mail address | Regulatory. Affairs@materialise.be | | Additional contact person | Jenny Jones | | Contact title | Global Quality Regulatory Manager | | Contact e-mail address | Jenny.Jones@materialise.com | ## Submission date The date of the Traditional 510(k) submission is April 17, 2023. # Submission Information | Trade Name | Materialise Shoulder System™<br>Materialise Shoulder Guide and Models<br>SurgiCase Shoulder Planner | |--------------------------|-----------------------------------------------------------------------------------------------------| | Common Name | Patient specific instrumentation for shoulder<br>arthroplasty + 3D planning software | | Classification Name | Prosthesis, Shoulder, Semi-Constrained,<br>Metal/Polymer Cemented | | Primary product code | QHE (21 CFR 888.3660) | | Additional product codes | KWS (21 CFR 888.3660)<br>PHX (21 CFR 888.3660) | # Predicate Device The predicate device to which substantial equivalence is claimed: {5}------------------------------------------------ | Trade or proprietary or model name | Materialise Shoulder System™<br>Materialise Shoulder Guide and Models<br>SurgiCase Shoulder Planner | |------------------------------------|-----------------------------------------------------------------------------------------------------| | 510(k) number | K220452 | | Decision date | August 17, 2022 | | Classification product code | QHE (21 CFR 888.3660)<br>KWS (21 CFR 888.3660)<br>PHX (21 CFR 888.3660) | | Manufacturer | Materialise N.V. | #### Reference Device | Trade or proprietary or model name | Materialise Shoulder System™<br>Materialise Shoulder Guide and Models<br>SurgiCase Shoulder Planner | |------------------------------------|-----------------------------------------------------------------------------------------------------| | 510(k) number | K230315 | | Decision date | March 6, 2023 | | Classification product code | QHE (21 CFR 888.3660)<br>KWS (21 CFR 888.3660)<br>PHX (21 CFR 888.3660) | | Manufacturer | Materialise N.V. | #### Device Description Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: - . a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. - Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are ● based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patientspecific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graft-space between implant and bone, based on the preoperative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR. {6}------------------------------------------------ ## Indications for Use #### Hardware The Materialise Shoulder Guide are intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. ## The Materialise Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: - DePuy Synthes' . - -GLOBAL® APG+ Shoulder System (K052472) - DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077, -K203694) - GLOBAL® STEPTECH® APG Shoulder System (K092122) - - INHANCE™ Anatomic Shoulder System (K202716)1 - - INHANCE™ Reverse Shoulder System (K212737) - - Enovis'2 (DJO) . - Reverse® Shoulder Prosthesis (K051075, K111629, K092873) - - Turon® Shoulder System (K080402) - - AltiVate™ Anatomic Shoulder System (K162024) - - AltiVate™ Anatomic Augmented Glenoid (K213387) - - Smith+Nephew's 3 ● - Titan™ Total Shoulder System (K100448, K112438, K142413, K152047) - - -Titan™ Reverse Shoulder System (K130050, K161189, K173717, K181999) - Lima's . - SMR™ Shoulder System (K100858) - - SMR™ Reverse Shoulder System (K110598) - - SMR™ Modular Glenoid (K113254) (K143256) - - SMR™ 3-Pegs Glenoid (K130642) - - SMR™ TT Metal Back Glenoid (K133349) - - SMR™ 40mm Glenosphere (K142139) - - -SMR™ TT Augmented 360 Baseplate (K220792) - SMR™ TT Hybrid Glenoid (K220792) - - Stryker's ● {7}------------------------------------------------ - -ReUnion RSA Reverse Shoulder System (K183039) - -Reunion TSA Total Shoulder Arthroplasty System (K183039) ## Software SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 presurgical plan data file which can be used as input data to design the Materialise Shoulder Guide and Models. 1 The implant system was originally cleared under K202716 as the Ignite Anatomic Shoulder System and was rebranded by DePuy Synthes as INHANCE™ Anatomic Shoulder System. 2DJO company name changed to Enovis. The shoulder products of Enovis were originally cleared under the company name of DJO (Encore Medical). 3 The Integra shoulder portfolio was acquired by Smith+Nephew in 2020. The shoulder products of the Titan™ Shoulder System were transferred from Integra to Smith+Nephew. ### Functioning of the Device The Materialise Shoulder System™ generates a pre-surgical plan based on medical imaging the SurgiCase Shoulder Planner. The SurgiCase Shoulder Planner allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The SurgiCase Shoulder Planner allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, Materialise Shoulder Guide and Models are designed and manufactured based on the approved glenoid pre-surgical plan. Materialise Shoulder Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid components used with total and reverse shoulder arthroplasty procedures. The Materialise Shoulder Guide and Models are available for glenoid components only. ## Technological Characteristics The Materialise Shoulder System™ has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for positioning shoulder components, i.e. glenoid components and humeral components (same as the predicate device). The subject device's hardware is intended for positioning shoulder glenoid components only (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 glenoid 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 the same methods for design and verification and validation as the predicate device. {8}------------------------------------------------ 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 K220452 is the addition of the following Enovis' (the previous company name was DJO) component in the software component of the subject device for the surgeon to select during the planning stage: - AltiVate™ Anatomic Augmented Glenoid (K213387). - Ability to more easily visualize muscle elongation which previously had to be measured ● manually. The subject software technology differences have been demonstrated that they do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device. ### Hardware The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the predicate device. The main difference between the subject device hardware and the predicate device is the extension of compatibility of the SurgiCase Shoulder Guides and Models with additional Enovis' (the previous company name was DJO) Implant component: - AltiVate™ Anatomic Augmented Glenoid (K213387). - ## Performance Data (non-clinical) #### Hardware: Previous testing for biocompatibility, cleaning, 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 the same as that of the predicate device of Materialise Shoulder System™ K220452 and previously cleared devices K212569, K193560, K172054, K172054, K170893, K153602 and K131559, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559 are considered applicable to the subject device. #### 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 aqainst user needs. {9}------------------------------------------------ # Conclusion The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device. Therefore, it can be concluded that the Materialise Shoulder System™ is substantially equivalent to the predicate device.