(58 days)
No
The document describes a robotic surgical system for total knee replacement that uses stereotaxic instrumentation, optical tracking, and pre/intraoperative planning based on anatomical landmarks and imaging. There is no mention of AI or ML being used for tasks like image analysis, decision support, or robotic control beyond precise positioning based on the surgical plan. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: A therapeutic device directly treats or cures a disease or condition. This device is an instrumentation system designed to assist surgeons during total knee replacement surgery, primarily aiding in the accurate placement of knee implant components. It is not directly therapeutic in itself.
No
The device is described as a "stereotaxic instrumentation system" and is primarily used 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." While it helps in assessing the state of soft tissues and bone resections, this is for guiding the surgical procedure and implant placement, not for diagnosing a medical 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ROSA® Knee System is a stereotaxic instrumentation system used during total knee replacement surgery. It assists the surgeon in planning and executing the surgical procedure by providing spatial guidance and positioning of instruments.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on surgical planning and execution based on anatomical landmarks and imaging data.
Therefore, the ROSA® Knee System falls under the category of surgical or robotic-assisted surgical devices, not In Vitro Diagnostics.
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 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 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 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.
Mentions image processing
Not Found
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, Operating Room
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)
Non-Clinical Tests: The existing performance testing that was performed for the predicate device remains unchanged and is still applicable for the proposed device.
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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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. 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
1
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,
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)
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) | Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | Aura Helena Corredor
Regulatory Affairs Associate Specialist
Telephone: 514-436-3467 | | | |
| Date: | January 27, 2023 | | | |
| 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 | K221928 | |
| Purpose and Device | facilitate implant positioning intra-operatively. | | 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 | |
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:
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- . 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.