ROSA® Shoulder System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 21, 2024 Orthosoft Inc (d/b/a Zimmer CAS) Sankalp Dere Regulatory Affairs Project Manager 75 Queen Street Suite 3300 Montreal, QC H3C 2N6 Canada Re: K233199 Trade/Device Name: ROSA® Shoulder System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: January 18, 2024 Received: January 22, 2024 Dear Sankalp Dere: 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. {1}------------------------------------------------ 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" (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 QS 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. 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). Sincerely, Tejen D. Soni -S For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair {2}------------------------------------------------ and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233199 Device Name ROSA® Shoulder System #### Indications for Use (Describe) The ROSA® Shoulder System, for use with the ROSA RECON platform, is indicated as a stereotaxic instrumentation system for Total Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate of the shoulder implant components. The robotic arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intraoperatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT based imaging technology. It includes a robotic arm, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. The ROSA Shoulder System is designed for use on a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA Shoulder System. The ROSA Shoulder System is to be used with the following shoulder replacement systems in accordance with their indications and contraindications: · Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System. · Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System. Type of Use (Select one or both, as applicable) | <div style="display:flex; align-items:center;"><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## 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 In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ROSA Shoulder System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019. | Sponsor: | Orthosoft Inc (d/b/a. Zimmer CAS)<br>75 Queen Street, Suite 3300<br>Montreal, QC, Canada H3C 2N6<br>Establishment Registration Number: 9617840 | | | | | | | | | | | | | | | | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | Contact Person: | Sankalp Dere<br>Regulatory Affairs Project Manager<br>SankalpSanjay.Dere@zimmerbiomet.com | | | | | | | | | | | | | | | | | Date: | 27 SEP 2023 | | | | | | | | | | | | | | | | | Subject Device: | Trade Name: ROSA® Shoulder System<br>Common Name: ROSA Shoulder System, ROSA Shoulder, ROSA TSA System<br>Classification Name:<br>• OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560)<br>• LLZ - Medical image management and processing system (21 CFR 892.2050) | | | | | | | | | | | | | | | | | Predicate Device: | Device Manufacturer 510(k) Number Predicate or Reference ExactechGPS Total<br>Shoulder Application,<br>Equinoxe Planning<br>Software Blue Ortho K213546 Primary<br>Predicate ROSA Knee System Zimmer CAS K230243 Secondary<br>Predicate | | | | | | | | | | | | | | | | | Purpose and Device Description: | The ROSA® Shoulder system (RSS) for use with ROSA® RECON Platform (cleared via K230243) is used to assist surgeons in performing Total Shoulder Arthroplasty (TSA) for both anatomic and reverse techniques. It features humeral resection and glenoid reaming capabilities to reproduce the preoperative plan intraoperatively with | | | | | | | | | | | | | | | | {5}------------------------------------------------ | | The RSS uses a Non-Device Medical Device Data System (MDDS)<br>called the Zimmer Biomet Portal, which manages the creation and<br>tracking of surgical cases. The cases with the pre-operative planning<br>based on surgeon preferences reside on the portal until they are<br>uploaded to the ROSA RECON Platform before surgeries.<br><br>The intra-operative workflow and surgical concepts implemented in<br>the system remain close to the conventional TSA workflow. As such,<br>at the time of the surgery, the system mainly assists the surgeon in (1)<br>determining reference alignment axes in relation to anatomical<br>landmarks, (2) planning the orthopedic implants location intra-<br>operatively based on these reference alignment axes and orthopedic<br>implant geometry, and (3) precisely position the humeral cut guide and<br>glenoid reamer relative to the planned orthopedic implant location by<br>using a robotic arm. | |---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The ROSA® Shoulder System, for use with the ROSA® RECON<br>platform, is indicated as a stereotaxic instrumentation system for Total<br>Shoulder Arthroplasty (TSA) surgery. It is used to assist the surgeon<br>in providing software-defined spatial boundaries for orientation and<br>reference to identifiable anatomical structures for the accurate<br>placement of the shoulder implant components.<br><br>The robotic arm placement is performed relative to anatomical<br>landmarks and bony anatomy as recorded using the system<br>intraoperatively, and based on a three-dimensional representation of<br>the bone structures determined pre-operatively using compatible CT<br>based imaging technology.<br><br>It includes a robotic arm, an optical sensor navigation system and<br>accessories, software system, surgical instruments and accessories. | | | The ROSA® Shoulder System is designed for use on a skeletally<br>mature patient population. The target population has the same<br>characteristics as the population targeted by the implants compatible<br>with the ROSA® Shoulder System.<br><br>The ROSA® Shoulder System is to be used with the following<br>shoulder replacement systems in accordance with their indications and<br>contraindications:<br>• Humerus implants: Comprehensive® Total Shoulder System,<br>Comprehensive® Reverse Shoulder System, Identity® Shoulder<br>System and Identity® Reverse Shoulder System.<br>• Glenoid implants: Alliance™ Glenoid and Comprehensive® Reverse Shoulder System. | | | | | Contraindications: | The ROSA® Shoulder System may not be suitable for use in case of:<br>• Shoulder pathologies with significant bone loss<br>• Shoulder pathology severely limiting range of motion<br>• Active infections of the shoulder joint area<br>• Shoulder replacement revision surgery<br>• Presence of strong infrared sources or infrared reflectors in the<br>vicinity of the trackers<br>• Contraindications for the implants as given by the implant<br>manufacturer<br>• Implants that are not compatible with the system<br>• Presence of pre-existing radio-opaque elements that could<br>interfere with pre-operative image acquisition or intra-operative<br>registration | | Summary of<br>Technological<br>Characteristics: | The rationale for substantial equivalence is based on consideration of<br>the following characteristics:<br>• Indications for Use/Intended Use: The proposed device has the<br>same intended use and similar indications for use as the<br>predicates. The devices are intended to assist surgeons by<br>providing software-defined spatial boundaries for orientation, and<br>reference information to relative anatomical structures for<br>accurate implant component placement.<br>• The proposed and the predicates allow users for patient bone<br>registration within the software and use it to guide instruments<br>intra-operatively in real time using similar navigation system.<br>• The proposed and ROSA predicate device share the same<br>previously cleared ROSA RECON Platform with its major core<br>hardware and software components, tracking system, various<br>instrumentation including reusable and disposable. The proposed<br>and ROSA predicate use the robotic arm on the ROSA RECON<br>Platform to assist the guidance of instruments.<br>• The proposed and primary predicate assist surgeon using similar<br>intra-operative instruments guiding to perform the glenoid<br>reaming based on the surgeon's plan. | | Summary of<br>Performance Data<br>(Nonclinical and/or<br>Clinical): | The following performance data was provided in support of the<br>substantial equivalence determination:<br>Biocompatibility Testing<br>The biocompatibility evaluation for ROSA Shoulder System was<br>conducted in accordance with ISO 10993. The evaluation shows that<br>the ROSA Shoulder devices meets biocompatibility requirements.<br>Electromagnetic Compatibility (EMC) and Electrical Safety | | Substantial Equivalence Conclusion: | Both the proposed device and predicate devices have the same intended use and similar indications for use and are used to guide instrumentation to assist with orthopedic surgery. The technological characteristics between the proposed device and the primary predicate are similar with bone registration and intra-operatively instrument guidance with live tracking. The proposed device does not perform any pre-operative surgical planning as is the case with primary predicate. The proposed ROSA Shoulder System and the secondary ROSA predicate utilize the same ROSA RECON Platform with its core hardware and software components. In addition, the proposed device and ROSA predicate use the robotic arm to assist the guidance of instruments. In summary, any differences between the devices do not raise new questions of safety and effectiveness and verification and validation | | | | | | | | | Electrical Safety and EMC testing was conducted on the ROSA RECON Platform. The device complies with recognized standards: IEC 60601-1, IEC 60601-1-2 & IEC 60601-1-6 standards.<br>Device Performance Testing<br>Verification and Validation Testing for ROSA Shoulder System was conducted with the following aspects:<br>• Performance Tests- to ensure the performance of the implemented features and verify related design inputs<br>• Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs<br>• Usability Engineering- addressed user interactions with ROSA Shoulder System<br>• Validation Lab- performed to validate that using ROSA Shoulder System is safe and effective and that the performances of the system are acceptable under full simulated use on cadaveric specimens<br>Software Verification and Validation Testing<br>Software tests were conducted to satisfy requirements of the FDA Guidance for the Content Premarket Submissions for Device Software Functions and IEC 62304 (Medical Device Software - Life Cycle Processes). The software was considered an "Enhanced" Documentation Level, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Shoulder System does not raise any new issues of safety and effectiveness as compared to the predicate devices. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | activities demonstrate that the proposed device is at least as safe and | |-------------------------------------------------------------------------| | effective as the legally marketed predicate devices. |