(60 days)
Not Found
No
The summary describes a stereotactic robotic system for surgical guidance based on CT data and pre-surgical planning, but it does not mention the use of AI or ML algorithms for any of its functions. The term "intelligent" is used in a general sense to describe the robotic arm's ability to constrain movement based on software-defined boundaries, not necessarily implying AI/ML.
Yes.
The device assists surgeons in orthopedic procedures, including total knee arthroplasty and hip procedures, indicating its use in treating a medical condition or assisting in medical procedures that have a therapeutic effect.
No.
Explanation: The Mako System is described as a stereotactic instrument and robotic arm intended to assist surgeons with pre-surgical planning, implant placement, and intraoperative navigation by providing guidance and manipulating tools. It does not state that it analyzes or interprets medical data to provide a diagnosis of a patient's condition or disease. Its function is to facilitate surgical procedures, not to diagnose.
No
The device description explicitly states that the Mako System includes hardware components such as a robotic arm, integrated cutting system, optical detector, computer, dedicated instrumentation, planning laptop, and tools and accessories, in addition to software.
Based on the provided text, the Mako System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Mako System's Intended Use: The Mako System's intended use is clearly described as assisting surgeons during orthopedic procedures by providing spatial boundaries, orientation, and reference information based on CT data. It is a surgical guidance and planning tool.
- No Specimen Examination: The description of the Mako System and its intended use does not involve the examination of any specimens taken from the human body. It works with imaging data (CT scans) of the patient's anatomy.
Therefore, the Mako System falls under the category of surgical planning and guidance systems, not In Vitro Diagnostics.
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)
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 Make System is indicated for use in surgical knee and hip 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:
- Unicondylar knee replacement and/or patellofemoral knee replacement
- Total Hip Arthroplasty (THA)
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Mako System with the subject Total Hip 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.
Once configured for a specific application, the Mako robotic-arm 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Knee, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical knee procedures, surgical hip procedures
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)
The modified Mako System with the Mako Total Hip Application has been evaluated through the following non-clinical performance testing:
- Software testing: .
- Treatment Design Application Full Software Run Through
- Bone Registration Accuracy Verification
- Mako Total Hip Application Full System Run Through
Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.
The modified Mako System with the Mako Total Knee Application has been evaluated through the following non-clinical performance testing:
- Software testing:
- Treatment Design Application Full Software Run Through
- Bone Registration Accuracy Verification
- Mako Total Knee Application Full System Run Through
Performance testing has demonstrated that the characteristics of the subject Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
September 24, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
MAKO Surgical Corp. Shikha Khandelwal Senior Staff Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K191998
Trade/Device Name: Mako Total Hip Application, Mako Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 23, 2019 Received: July 26, 2019
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. 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
1
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 (OS) 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 mediation-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, 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 List of Cleared Devices in K191998
2
List of Cleared Devices in K191998
-
Mako Total Hip Application
-
Mako Total Knee Application
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 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."
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Mako Total Hip 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 Make System is indicated for use in surgical knee and hip 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:
- · Unicondylar knee replacement and/or patellofemoral knee replacement
- · Total Hip Arthroplasty (THA)
| 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."
5
Image /page/5/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a blue, stylized arc that resembles a shark fin or a wave. The logo is clean and modern, with a focus on the company name and a simple, memorable graphic element.
555 Davie Road · Ft. Lauderdale, FL 33317 27.2044 • Fax 954.927.0446 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 |
| Date Prepared: | July 23, 2019 |
| Proprietary Name: | Mako Total Hip Application |
| Common Name: | Total Hip Application (THA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR Section 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Substantial Equivalence Claimed To:
The subject device, the Mako Total Hip Application, is substantially equivalent to the predicate device, the Mako Total Hip Application, cleared via K170593.
Device Modification:
The following changes have been made to the Mako Total Hip Application:
- Pre-operative Planning Process Treatment Design Application (TDA) is a ● new software tool which will be implemented into the pre-operative planning process of Mako Total Hip procedures.
The software tool is intended to accept CT imaging data and process it to generate the patient-specific 3D models and anatomic landmarks utilized for pre-operative implant planning.
6
Description:
The Mako System with the subject Total Hip 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.
Once configured for a specific application, the Mako robotic-arm 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 predicate device are listed below: | ||
|---|---|---|
| Technological | ||
| Characteristics | Mako Total Hip Application | Mako Total Hip Application – K170593 |
| 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 |
The technological characteristics of the Mako Total Hip Application compared to the predicate device are listed helow
Intended Use - The subject device has the same intended use as that specified in the cleared 510(k) premarket notification for the predicate device.
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 and hip 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:
7
- Unicondylar knee replacement and/or patellofemoral knee replacement
- . Total Hip Arthroplasty (THA)
Performance Data – The modified Mako System with the Mako Total Hip Application has been evaluated through the following non-clinical performance testing:
- Software testing: .
- o Treatment Design Application Full Software Run Through
- o Bone Registration Accuracy Verification
- o Mako Total Hip Application Full System Run Through
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.
8
Image /page/8/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo consists of the word "MAKO" in large, bold, black letters, with the words "SURGICAL CORP" in smaller, black letters underneath. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.
555 Davie Road · Ft. Lauderdale, FL 33317 .2044 · Fax 954.927.0446 akosurgical.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 |
| Date Prepared: | July 23, 2019 |
| Proprietary Name: | Mako Total Knee Application |
| Common Name: | Total Knee Application (TKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR Section 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Substantial Equivalence Claimed To:
The subject device, the Mako Total Knee Application, is substantially equivalent to the predicate device, Mako Total Knee Application, cleared via K172219.
Device Modification:
The following changes have been made to the Mako Total Knee Application:
- Pre-operative Planning Process Treatment Design Application (TDA) is a ● new software tool which will be implemented into the pre-operative planning process of Mako Total Knee procedures.
The software tool is intended to accept CT imaging data and process it to generate the patient-specific 3D models and anatomic landmarks utilized for pre-operative implant planning.
9
Description:
The Mako System with the subject 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.
Once configured for a specific application, the Mako robotic-arm 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:
| Technological
| Characteristics | Mako Total Knee Application | Mako Total Knee Application – K172219 |
|---|---|---|
| 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 |
The technological characteristics of the Mako Total Knee Application compared to the predicate device are listed below:
Intended Use - The subject device has the same intended use as that specified in the cleared 510(k) premarket notification for the predicate device.
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:
10
-
. 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)
Performance Data – The modified Mako System with the Mako Total Knee Application has been evaluated through the following non-clinical performance testing:
- . Software testing:
- o Treatment Design Application Full Software Run Through
- o Bone Registration Accuracy Verification
- o Mako Total Knee Application Full System Run Through
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the subject Mako Total Knee Application is equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.