(63 days)
No
The document explicitly states "There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices." and "No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices." There is no mention of AI or ML in the provided text.
Yes
The device is a knee replacement system used to treat osteoarthritis or posttraumatic arthritis, which are medical conditions, aligning with the definition of a therapeutic device.
No
The device description clearly states it is a knee replacement system intended for implantation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Multicompartmental Knee (MCK) System," which is a physical implant. The submission is for changes to labeling, not a software component.
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 RESTORIS™ Multicompartmental Knee (MCK) System is for "single or multi-compartmental knee replacement". This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the implant components and changes to labeling, further reinforcing that it's a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the RESTORIS™ Multicompartmental Knee (MCK) System is a surgical implant used for knee replacement, not an IVD.
N/A
Intended Use / Indications for Use
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- · Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Product codes
HSX, KRR, NPJ, HRY
Device Description
The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint femorotibial and/or patellofemoral articular surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices. There is no impact to the device design or the physical characteristics of the devices. Testing submitted as part of previously cleared premarket notifications is applicable to this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K172326, K150307, K090763, K082172, K082088, K082081, K080368
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
June 2, 2022
Image /page/0/Picture/1 description: The image shows 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Mako Surgical Corp. Emily DiMambro Staff RA Specialist 3365 Enterprise Ave Weston, Florida 33331
Re: K220930
Trade/Device Name: Restoris Multi-Compartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: HSX, KRR, NPJ, HRY Dated: March 31, 2022 Received: March 31, 2022
Dear Emily DiMambro:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Ting Song, 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) K220930
Device Name
Restoris Multi-Compartmental Knee System
Indications for Use (Describe)
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- · Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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."
3
510(k) Summary
Manufacturer Identification
MAKO Surgical Corp. 3365 Enterprise Ave. Weston, FL 33331 USA
Official Contact Person:
Emily DiMambro Staff Regulatory Affairs Specialist emily.dimambro@stryker.com 201-831-5140
Device Identification
Proprietary Name Restoris Multicompartmental Knee System
Predicate Device Restoris Multicompartmental Knee System - K180612
Regulatory Class Class II
CFR Reference, Product Code, and Classification Name
21 CFR 888.3520 - HSX - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis 21 CFR 888.3540 - KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis 21 CFR 888.3560 - NP] - Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis 21 CFR 888.3530 - HRY - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
Device Description:
The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.
4
Intended Use:
The intended use of the subject devices is identical to the intended use described in K180612. The Restoris Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System
Indications for Use:
The indications for use for the subject devices are identical to the indications for use as submitted in K180612.
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post- traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- · Medial unicondylar
- Lateral unicondylar
- Patellofemoral
- Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Summary of Technological Characteristics:
There is no change to the technological characteristics of the Restoris MCK Implant System as described in K180612. The changes described in this Changes Being Effected premarket notification do not impact the technological characteristics of the subject devices.
Non-Clinical or Clinical Testing:
No additional testing was performed as part of this submission, as the only changes being made are to the labeling for the devices. There is no impact to the device design or the physical characteristics of the devices. Testing submitted as part of previously cleared premarket notifications is applicable to this submission.
Conclusion:
The subject Restoris MCK Implant System is substantially equivalent to the predicate Restoris MCK Implant System as cleared in K180612. The subject devices are identical in intended use, indications, design, technological characteristics and operational principles as described in K180612. The only changes made to the subject devices are the additional contraindication and minor labeling clarifications.