ROSA® Knee System

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March 29, 2023 Orthosoft d/b/a Zimmer CAS Aura Corredor Regulatory Affairs Associate Specialist 75 Queen Street, Suite 3300 Montreal, OC H3C 2N6 Canada Re: K230243 Trade/Device Name: ROSA® Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2023 Received: January 30, 2023 Dear Aura Corredor: 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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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, Shumaya Ali-S Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K230243 Device Name ROSA® Knee System #### Indications for Use (Describe) The ROSA Knee System, for use with the ROSA® RECON Platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories. The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System. The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> <td><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D) </td></span></div> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <div> <input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C) </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." {3}------------------------------------------------ ## 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® Knee 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 St., Suite 3300<br>Montreal, QC, CANADA H3C 2N6<br>Establishment Registration Number: 9617840 | | | | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Contact Person: | Aura Helena Corredor<br>Regulatory Affairs Associate Specialist<br>Telephone: 514-436-3467 | | | | | Date: | January 27, 2023 | | | | | Subject Device: | Trade Name: ROSA® Knee System<br>Common Name: ROSA® Knee System<br>Classification Name:<br>OLO- Orthopedic Stereotaxic Instrument (21 CFR<br>●<br>882.4560) | | | | | Predicate Device: | Manufacturer | Device Name | 510(k) Number | | | | Zimmer CAS | ROSA®<br>Knee<br>System | K221928 | | | Purpose and Device | facilitate implant positioning intra-operatively. | | The ROSA® Knee System for use with the ROSA RECON<br>Platform is used to assist surgeons in performing Total Knee<br>Arthroplasty (TKA) with features to assist with the bone<br>resections as well as assessing the state of the soft tissues to | | The ROSA® Knee System uses a Non-Device Medical Device Data System (Non-Device MDDS) called the Zimmer Biomet Drive Portal, which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries. {4}------------------------------------------------ If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI systems (X-PSI Knee System or CAS PSI Knee System) to create a 3D model of the patient's femur/tibia and allows the preparation of a preoperative surgical plan. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intraoperative landmarks. The intraoperative workflow and surgical concepts implemented in the system remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a preoperative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm. The purpose of this submission is to add new disposable instruments: Sterile Checkpoint Screws Size 13mm, Size 15mm and Size 17mm. The modification considered in this 510(k) is to provide the checkpoint screws in sterile packaging to the end user. Indications for Use: The ROSA® Knee System, for use with the ROSA RECON Platform is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. > The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan; optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools. {5}------------------------------------------------ It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories. The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System. The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS. The ROSA® Knee System may not be suitable for use in case of: - . hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum); - hip pathology severely limiting range of motion (e.g. ● arthrodesis, severe contractures, chronic severe dislocation); - active infections of the knee joint area; ● - knee replacement revision surgery; ● - presence of strong infrared sources or infrared ● reflectors in the vicinity of the trackers; - contraindications for the implant as given by the ● implant manufacturer; - implants that are not compatible with the system ● The rationale for substantial equivalence is based on Summary of Technological Characteristics: consideration of the following characteristics: - Intended Use: Same as predicate device - Indications for Use: Same as predicate device - Technological Characteristics: Same as predicate device K230243 Page 3 of 4 Contraindications: {6}------------------------------------------------ - . Principle of Operation: Same as predicate device - . Instrumentation: Same as predicate device except for the addition of new disposable instruments-Sterile Checkpoint Screws Size 13mm, Size 15mm and Size 17mm which are sold in sterile packaging to end users. ## Summary of Performance Data (Nonclinical and/or Clinical) #### Non-Clinical Tests: ● - The existing performance testing that was O performed for the predicate device remains unchanged and is still applicable for the proposed device. ## Substantial Equivalence Conclusion: Both the proposed device and predicate device have the same intended use and indications for use. The technological characteristics between the proposed device and predicate are identical with differences in the instrumentation where the proposed device checkpoint screws are sold in a sterile packaging to end users. In sum, any differences between the devices do not raise new questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate device. However, the information provided herein demonstrates that: - o Any differences do not raise new questions of safety and effectiveness; - o Verification and Validation activities demonstrate that the proposed device is at least as safe and effective as the legally marketed predicate device.