(72 days)
Not Found
No
The summary describes a stereotactic surgical system that uses CT data for pre-surgical planning and intraoperative navigation with a robotic arm that provides spatial boundaries. While it uses software and is described as an "intelligent" tool holder, there is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML, or image processing techniques that might imply AI/ML. The focus is on stereotactic guidance and software-defined constraints.
No.
The device assists the surgeon with navigation and tool guidance during orthopedic procedures, but it does not directly treat a disease or condition itself.
No
The Mako System is intended to assist surgeons during orthopedic procedures by providing spatial boundaries, reference information, and guidance for pre-surgical planning, implant placement, and intraoperative navigation. It does not diagnose medical conditions.
No
The device description explicitly lists multiple hardware components including a robotic arm, integrated cutting system, optical detector, computer, dedicated instrumentation, planning laptop, and tools and accessories.
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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Mako System's Intended Use: The Mako System's intended use is to "assist the surgeon in providing software spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures." It is used during surgery to guide the surgeon, not to analyze samples taken from the body.
- Device Description: The description details a stereotactic instrument with a robotic arm, cutting system, optical detector, computer, etc., all used for surgical guidance and planning based on CT data of the patient's anatomy. This is consistent with a surgical assistance device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
In summary, the Mako System is a surgical guidance and assistance system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mako System is intended to assist the surgeon in providing software 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 implants systems compatible with this system: -
· Triathlon Total Knee System (CR/CS/PS 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 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
| Validation / Verification
Method | Purpose | Validation / Verification
Results |
|-------------------------------------|---------|--------------------------------------|
| Product Specification
Verification | Verify that TKA fields and
values implemented into
the eRequest application
must match the TKA
Product Specifications. | Pass |
| eRequest – Full System
Run Through for TKA
Application | Verify the integration of
the eRequest Lifecycle
into the Mako System
provides adequate
functionality to
successfully complete the
pre-operative planning
workflow | Pass |
| Planning Workflow - TKA
Validation | Validate in a simulated-
use environment, with
appropriate user, that the
implementation of
eRequest LifeCycle into
the Mako System provides
adequate functionality to
successfully complete the
pre-operative workflow
and satisfies the customer
requirements. | Pass |
Conclusions: 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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
MAKO Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K170581
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: February 27, 2017 Received: February 28, 2017
Dear Shikha Khandelwal:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/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 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
2
Indications for Use
510(k) Number (if known)
Device Name
Mako Total Knee Application
Indications for Use (Describe)
Indications for Use:
The Mako System is intended to assist the surgeon in providing software 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 implants systems compatible with this system: -
· Triathlon Total Knee System (CR/CS/PS 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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in a bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font below. Above the word "MAKO" is a blue, curved shape that resembles a wave or fin. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
1555 Davie Road • Ft. Lauderdale, FL 3331 hone 954.927.2044 • Fax 954.927.04 ww.makosurgical.com
510(K) SUMMARY
| Sponsor: | MAKO Surgical Corp.
2555 Davie Road, Fort Lauderdale, FL 33317 |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Shikha Khandelwal, PhD
Shikha.khandelwal@stryker.com
Phone: 201-831-6921
Fax: 201-831-3921 |
| Date Prepared: | February 24, 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 K143752.
Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning workflow of the Mako Total Knee application.
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.
4
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 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.
Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Total Knee Application compared to the predicate device are listed below:
| Technological
Characteristics | Mako Total Knee Application | Mako Total Knee Application
(K143752) |
|----------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 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 |
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 Primary)
-
Kinetis Total Knee System (CR/UC)
5
Performance Data:
| Validation / Verification
Method | Purpose | Validation / Verification
Results |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Specification
Verification | Verify that TKA fields and
values implemented into
the eRequest application
must match the TKA
Product Specifications. | Pass |
| eRequest – Full System
Run Through for TKA
Application | Verify the integration of
the eRequest Lifecycle
into the Mako System
provides adequate
functionality to
successfully complete the
pre-operative planning
workflow | Pass |
| Planning Workflow - TKA
Validation | Validate in a simulated-
use environment, with
appropriate user, that the
implementation of
eRequest LifeCycle into
the Mako System provides
adequate functionality to
successfully complete the
pre-operative workflow
and satisfies the customer
requirements. | Pass |
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.
Image /page/5/Picture/4 description: The image shows a light blue abstract shape against a white background. The shape is curved and pointed at both ends, with a notch in the middle of the top edge. The shape resembles a stylized wing or a swooping curve. The overall impression is simple and minimalist.