(29 days)
Not Found
No
The summary describes a knee implant system and its use with a robotic arm system (RIO), but there is no mention of AI or ML being incorporated into the device itself or the robotic system's functionality as described in this summary. The performance studies focus on mechanical and material properties of the implant.
Yes.
The device is a knee replacement system used to treat osteoarthritis and posttraumatic arthritis, directly addressing a medical condition to restore function.
No
This device is a multicompartmental knee replacement system, an implant used in surgery, not a diagnostic tool.
No
The device description clearly states that the RESTORIS™ Multicompartmental Knee (MCK) System is an "implant system" composed of physical components like femoral condyle components, tibial components, and patella components. This indicates it is a hardware device, not software-only.
Based on the provided information, the RESTORIS™ Multicompartmental Knee (MCK) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for single or multi-compartmental knee replacement in individuals with osteoarthritis or posttraumatic arthritis. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The device is described as an implant system composed of components like femoral condyle components, tibial components, and patella components. These are physical parts designed to be surgically implanted into the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a person's health status. The performance studies focus on mechanical properties and wear, not diagnostic accuracy.
IVD devices are used in vitro (outside the body) to examine specimens. The RESTORIS™ MCK System is used in vivo (inside the body) as a surgical implant.
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 RIO®, 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
NPJ, HSX, HRY, KRR, OIY
Device Description
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni:
- Unicompartmental femoral condyle components
- Unicompartmental tibial onlay components (tibial baseplate and tibial onlay insert)
- Unicompartmental tibial inlay components
- RESTORISTM MCK PF:
- Patellofemoral trochlear components
- Patella components
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multicompartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (tibiofemoral 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
The RESTORIS™ Multicompartmental Knee System has been evaluated through nonclinical performance testing for:
- Insert Snaplock Strength
- Tibial Insert / Baseplate Micromotion
- Tibio-Femoral Range of Motion
- Tibio-Femoral Instability
- Tibio-Femoral Contact Area and Stress
- Tibial Insert Fatigue
- Tibial Insert Wear
- Packaging Validation
- Gas Plasma Sterilization Validation
- 5 Year Aging
The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
MAKO Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K150307
Trade/Device Name: RESTORIS™ Multicompartmental Knee (MCK) System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ, HSX, HRY, KRR, OIY Dated: January 29, 2015 Received: February 9, 2015
Dear Mr. Reeves:
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. 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
1
Page 2 - Mr. Jonathan Reeves
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150307
Device Name
RESTORISTM Multicompartmental Knee (MCK) System
Indications for Use (Describe)
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in smaller, thinner, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or a stylized mountain range.
2555 Davie Road • Ft. Lauderdale, FL 33317 Phone 954.927.2044 • Fax 954.927.0446 www.makosurgical.com
510(K) SUMMARY
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number/ Fax Number: | (Ph) 954-628-0665; (F) 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | January 29, 2015 |
| Proprietary Name: | |
| Knee System | The RESTORIS™ Multicompartmental (MCK) |
| Common Name: | Partial Knee System |
| Classification: | Class II |
Product Codes/Classification #:
| Code of Federal
Regulations | Product
code | Description |
|--------------------------------|-----------------|-----------------------------------------------------------------------------------------------|
| 21 CFR 888.3520 | HSX | Knee joint femorotibial metal/polymer non constrained
cemented prosthesis |
| 21 CFR 888.3530 | HRY | Knee joint femorotibial metal/polymer semi constrained
cemented prosthesis |
| 21 CFR 888.3540 | KRR | Knee joint patellofemoral polymer/metal semi
constrained cemented prosthesis |
| 21 CFR 888.3560 | NPJ | Knee joint patellofemorotibial polymer/metal/polymer
semi constrained cemented prosthesis |
| 21 CFR 888.3560 | OIY | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis. |
Reason for 510(k) submission:
Special 510(k): Device modification with no change to fundamental scientific technology or intended use
Device Modification:
- Addition of Highly Cross-linked UHMWPE (X3) onlay tibial insert ●
- Gas Plasma Sterilization ●
- . Packaging
Device Description:
4
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni: ●
- o Unicompartmental femoral condyle components
- Unicompartmental tibial onlay components (tibial baseplate and tibial o onlay insert)
- Unicompartmental tibial inlay components o
- RESTORISTM MCK PF: o
- o Patellofemoral trochlear components
- o Patella components
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multicompartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
Intended Use:
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)
The RESTORIS™ Multicompartmental Knee System is for single use only and is intended for implantation with bone cement.
Substantial Equivalence:
The RESTORIS Multicompartmental Knee System is substantially equivalent to the following 510(k) cleared devices.
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RESTORIS Multicompartmental Knee System | MAKO | K133039 |
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Technological Characteristics:
The RESTORIS™ Multicompartmental Knee System is similar to legally marketed devices listed previously in that they share the same indications for use, are manufactured from the same or similar material, have same design/technological characteristics and have performance characteristics adequate to withstand anticipated physiological loading.
Performance Data:
The RESTORIS™ Multicompartmental Knee System has been evaluated through nonclinical performance testing for:
- Insert Snaplock Strength o
- Tibial Insert / Baseplate Micromotion o
- Tibio-Femoral Range of Motion o
- o Tibio-Femoral Instability
- Tibio-Femoral Contact Area and Stress
- o Tibial Insert Fatigue
- Tibial Insert Wear ●
- Packaging Validation
- Gas Plasma Sterilization Validation
- 5 Year Aging o
Conclusions of Non-clinical Data:
The results of performance testing indicated the device performed within the intended use and
did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
Summary of Design Control Activities:
The risk analysis activities for this device modification include a risk management plan, hazard analysis and Failure Modes and Effects Analysis (FMEAs). Based upon the review of this data and information obtained through verification and validation activities, there are no unacceptable levels of risks that have been identified resulting from the device modification.