(59 days)
Not Found
No
The description focuses on stereotactic guidance, robotic assistance, and software-defined boundaries based on CT data, without mentioning AI or ML algorithms for planning, navigation, or control. The "intelligent" tool holder description refers to passive constraint based on software boundaries, not AI-driven decision making.
No.
The Mako System is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and guidance, not to treat a disease or condition itself. It's a surgical tool, not a therapeutic device.
No
Explanation: The device is described as a "stereotactic instrument" and a "robotic arm" intended to "assist the surgeon" during orthopedic procedures by providing "spatial boundaries for orientation and reference information" and "stereotactic/haptic guidance." It is used for "pre-surgical planning, implant placement and interpretive/intraoperative navigation." These functions are procedural assistance and guidance, not diagnosis.
No
The device description explicitly lists multiple hardware components including a robotic arm, integrated cutting system, optical detector, computer, and dedicated instrumentation, in addition to the software.
Based on the provided information, the Mako System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Mako System's Function: The Mako System is a surgical assistance system used during orthopedic procedures. It uses imaging data (CT) and robotic technology to help the surgeon with planning, navigation, and preparing the anatomical site for implant placement. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for assisting the surgeon during orthopedic procedures by providing spatial boundaries and reference information to anatomical structures.
Therefore, the Mako System falls under the category of a surgical assistance or navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
• Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
- · Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts cemented primary)
- · Kinetis Total Knee System (CR/UC)
Product codes
OLO
Device Description
The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.
The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.
The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
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)
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:
- Cutting Accuracy Verification
- Full system Cadaver Validation
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the Mako Total Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.
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).
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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or office within the FDA.
MAKO Surgical Corp. Karen Ariemma Senior Manager Regulatory Affairs 2555 Davie Road Fort Lauderdale, Florida 33317
September 21, 2017
Re: K172219
Trade/Device Name: Mako Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 21, 2017 Received: July 24, 2017
Dear Karen Ariemma:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (DICE) 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. 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
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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Mako Total Knee Application
Indications for Use (Describe)
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
• Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
- · Triathlon Total Knee System (CR/CS/PS cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts cemented primary)
- · Kinetis Total Knee System (CR/UC)
| 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) |
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."
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Image /page/3/Picture/1 description: The image shows the 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, black letters. Above the word "MAKO" is a blue, curved shape that resembles a stylized shark fin or wave.
555 Davie Road • Ft. Lauderdale, FL 27.2044 • Fax 954.927.0 ww.makosurgical.com
510(k) SUMMARY
| Sponsor: | Mako Surgical Corp.
2555 Davie Road, Fort Lauderdale, FL 33317 |
|------------------------|-------------------------------------------------------------------|
| Contact Person: | Karen Ariemma
karen.ariemma@stryker.com
Phone: 201-831-5718 |
| Date Prepared: | July 21, 2017 |
| Proprietary Name: | Mako Total Knee Application |
| Common Name: | Total Knee Application (TKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Substantial Equivalence Claimed To:
The Mako Total Knee Application is substantially equivalent to the Mako Total Knee Application cleared via K170581.
Device Modification:
The following changes have been made to the Mako Total Knee Application:
- . Compatible implants - Addition of the Triathlon cementless components (CR and PS femoral components, tibial baseplates and patellar components), Triathlon All Poly tibial components and Triathlon TS inserts.
- . Labeling - Implant compatibility has been modified in the Indications for Use.
Description:
The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a
4
computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.
The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic/haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.
The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
| Technological
Characteristics | Mako Total Knee Application | Mako Total Knee Application
(K170581) |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Major
Components | Guidance Module, robotic arm, camera stand, cutting system, preoperative planning laptop. | Guidance Module, robotic arm, camera stand, cutting system, preoperative planning laptop. |
| Tools/accessories | Various reusable and disposable instruments | Various reusable and disposable instruments |
| Image Use | CT | CT |
Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Total Knee Application compared to
Intended Use/Indications for Use:
the predicate device are listed below:
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
-
. Total Knee Arthroplasty (TKA)
The implant systems compatible with the system: -
Triathlon Total Knee System (CR/CS/PS cemented and cementless primary) ●
-
Triathlon Total Knee System (TS inserts cemented primary) .
-
Kinetis Total Knee System (CR/UC) ●
5
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:
- Cutting Accuracy Verification ●
- Full system Cadaver Validation .
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the Mako Total Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.