(95 days)
Not Found
No
The summary describes a robotic surgical system that uses optical tracking and pre-operative or intra-operative anatomical landmarks for planning and guiding surgical cuts. While it uses software for planning and control, there is no mention of AI or ML being used for tasks like image analysis, decision support, or adaptive control. The system relies on defined spatial boundaries and surgical plans based on anatomical structures, not on learning from data.
No
The device is described as an "instrumentation system for total knee replacement (TKA) surgery" that assists the surgeon in placing knee implant components. It is not directly treating a disease or condition, but rather aids in a surgical procedure, which is an intervention.
No
Explanation: The device is described as a "stereotaxic instrumentation system" and "robotic arm" to assist in total knee replacement surgery by providing spatial boundaries, orientation, and reference information for component placement, assessing soft tissues, and guiding cut guides. Its purpose is to assist in surgical procedures, not to diagnose a condition.
No
The device description explicitly states that the ROSA Knee System includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories. This indicates it is a system with significant hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ROSA® Knee System is a stereotaxic instrumentation system for total knee replacement surgery. It assists the surgeon in providing spatial boundaries and reference information for implant placement. This is a surgical assistance system, not a diagnostic test performed on samples from the human body.
- Device Description: The description reinforces its role in assisting with bone resections and soft tissue assessment during surgery. It uses imaging and anatomical landmarks to guide the surgical process.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ROSA® Knee System does not perform any such analysis on biological samples.
- Focus on Surgical Guidance: The core function of the device is to provide guidance and precision during a surgical procedure.
Therefore, the ROSA® Knee System falls under the category of a surgical robotic system or computer-assisted surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
OLO
Device Description
The ROSA® Knee System for use with the ROSA RECON Platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.
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.
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 for the preparation of a pre-operative 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.
Mentions image processing
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 for the preparation of a pre-operative surgical plan.
The proposed and predicate device utilize image data that has been segmented to create a 3D model of the patient's bony anatomy
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patient population
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Performance Testing:
Verification and Validation Testing for ROSA Knee was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with ROSA Knee System
- Validation Lab- performed to validate that using ROSA Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing:
Software tests were conducted to satisfy requirements of the FDA Guidance for the Content Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software was considered a "major" level of concern, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
October 4, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.
Orthosoft d/b/a Zimmer CAS Kavina Veeren Regulatory Affairs Manager 75 Queen Street, Suite 3300 Montreal, QC H3C 2N6 Canada
Re: K221928
Trade/Device Name: ROSA® Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 30, 2022 Received: July 1, 2022
Dear Kavina Veeren:
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.
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
1
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) f or 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 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/cdrl-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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221928
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K221928 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
75 Queen St., Suite 3300
Montreal, QC, CANADA H3C 2N6
Establishment Registration Number: 9617840 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kavina Veeren
Regulatory Affairs Manager
Telephone: 574-245-8906 |
| Date: | June 30, 2022 |
| Subject Device: | Trade Name: ROSA ® Knee System
Common Name: ROSA ® Knee System |
| | Classification Name: |
| | • OLO- Orthopedic Stereotaxic Instrument (21 CFR 882.4560) |
| Predicate Device: | |
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Zimmer CAS | ROSA® Knee | |
| System | K182964 |
Purpose and Device Description:
The ROSA® Knee System for use with the ROSA RECON Platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.
4
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.
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 for the preparation of a pre-operative 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 (1) add additional compatible FDA cleared knee implant systems, Ti-Nidium® CR, Persona Ti-Nidium. As a result of this change, the labeling and Indications for Use has been updated to include this compatibility with these implant systems. (2) New instrumentation is being added to the subject device as well as the improvement of existing features and the addition of new features within the ROSA Knee Software Application.
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
5
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.
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
Contraindications:
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| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on
consideration of the following characteristics: |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • The proposed and predicate device are intended to assist
the surgeon in providing software defined spatial
boundaries for orientation |
| | • The proposed and predicate device assist in
intraoperative navigation of the patient's anatomy and are
utilized to facilitate implant positioning |
| | • The proposed and predicate device assist in joint
balancing techniques |
| | • The proposed and predicate device utilize image data that
has been segmented to create a 3D model of the patient's
bony anatomy |
| | • The proposed and predicate device share the same
previously cleared ROSA RECON Platform, and the
proposed and predicate device consists of major
components including a software system, navigation
system, various instrumentation including reusable and
disposable. |
| Summary of Performance Data
(Nonclinical and/or Clinical) | The following performance data was provided in
support of the substantial equivalence determination: |
| Biocompatibility Testing | No new testing was deemed necessary. |
| | Electrical Safety and Electromagnetic Compatibility (EMC) |
| | No new testing was deemed necessary on the ROSA
RECON Platform. |
| Device Performance Testing | |
| | Verification and Validation Testing for ROSA Knee was
conducted with the following aspects: |
| | • Physical/Performance Tests- to ensure the performance o
the implemented features and verify related design inputs |
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- Engineering Analysis- to ensure the performance of the ● implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with ROSA Knee System
- Validation Lab- performed to validate that using ROSA ● Knee System is equivalent to the predicate and that the performances of the system are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing
Software tests were conducted to satisfy requirements of the FDA Guidance for the Content Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software was considered a "major" level of concern, since a failure of the software could result in serious injury or death to the patient. The testing demonstrates that the ROSA Knee System does not raise any new issues of safety and effectiveness as compared to the predicate device(s).
Substantial Equivalence Conclusion
Both the proposed device and predicate device have the same intended use and similar indications for use. The proposed device and predicate utilize the same platform components. The technological characteristics between the proposed device and predicate are similar with differences in the software application and the addition of new instrumentation with the proposed device. 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.