(60 days)
No
The description focuses on stereotactic surgery, robotic assistance, haptic guidance, and pre-surgical planning based on CT data. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms. The "intelligent" tool holder description refers to software-defined spatial boundaries, not AI/ML capabilities.
No
The device is a surgical assistance system that provides haptic guidance and navigational support during orthopedic procedures, rather than directly treating a disease or condition.
No
The device is described as assisting the surgeon during orthopedic procedures by providing spatial boundaries and haptic guidance for implant placement and intraoperative navigation, not by diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a robotic arm, integrated cutting system, optical detector, camera, and computer, in addition to the software.
Based on the provided information, the Mako System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is intended to "assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures." This describes a surgical guidance and assistance system, 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 details a robotic arm, cutting system, optical detector, computer, and software used for surgical planning, implant placement, and intraoperative navigation. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The Mako System is a surgical assistance and navigation system used during orthopedic procedures, not a device for in vitro diagnostic testing.
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/PSR cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts cemented primary)
Product codes
OLO
Device Description
The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, a computer, dedicated instrumentation, operating software, 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 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 the 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)
The modified Mako System with the subject Mako Total Knee Application has been evaluated through the following non-clinical performance testing:
- Software Functional Testing ●
- Cutting System Accuracy
- Cable Reliability
- Software Performance Verification ●
- System Testing ●
- Cadaveric Design Validation ●
- . Summative Evaluation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
June 11, 2024
Image /page/0/Picture/1 description: The image contains 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, with the word "ADMINISTRATION" underneath.
MAKO Surgical Corp. Anne Edwards Principal Regulatory Affairs Specialist 3365 Enterprise Avenue Weston, Florida 33331
Re: K241011
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: April 11, 2024 Received: April 12, 2024
Dear Anne Edwards:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, | |
|---|---|
| Jesse Muir - Digitally signed by Jesse Muir -S | |
| S | Date: 2024.06.11 |
| 12:17:58 -04'00' |
For: 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
2
Indications for Use
510(k) Number (if known) K241011
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/PSR cemented and cementless primary)
- · Triathlon Total Knee System (TS inserts cemented primary)
| 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
510(k) SUMMARY
| Sponsor: | Mako Surgical Corp.
3365 Enterprise Ave
Weston, FL 33331 |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Anne Edwards
Principal Regulatory Affairs Specialist
Anne.Edwards@stryker.com
505-221-0267 |
| Date Prepared: | June 7, 2024 |
| 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, the Mako Total Knee Application, cleared in K220459.
In addition, the Stryker Q Guidance System used as part of the Mako System hardware is substantially equivalent to the reference device, the Q Guidance System cleared in K233542.
Device Modification:
Hardware changes: A new robotic arm part number has been created for compatibility with Stryker Q Guidance System, which replaces the Mako Camera Stand and Guidance Module.
Labeling: Labeling provided with the device has been updated to reflect the modifications made.
Software Changes: The Mako Total Knee Application has undergone minor modifications for compatibility with the Stryker Q Guidance System. The form, fit, and function of the clinical application have not changed.
4
Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters. The font is modern and clean.
Description:
The Mako System with the subject Mako Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, camera, a computer, dedicated instrumentation, operating software, 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 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 the 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 Device:
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 -
K220459 |
|----------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Major Components | Robotic arm, Stryker Q Guidance
System, cutting system. | Robotic Arm, Guidance Module,
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
The subject device has the same intended use as that specified in the cleared 510(k) premarket notification for the predicate device listed in this 510(k) premarket notification.
Indications for Use: Mako Total Knee Application
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:
5
-
. Total Knee Arthroplasty (TKA)
The implant systems compatible with the system: -
Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary) ●
-
. Triathlon Total Knee System (TS inserts cemented primary)
Performance Data - The modified Mako System with the subject Mako Total Knee Application has been evaluated through the following non-clinical performance testing:
- Software Functional Testing ●
- Cutting System Accuracy
- Cable Reliability
- Software Performance Verification ●
- System Testing ●
- Cadaveric Design Validation ●
- . Summative Evaluation
Conclusions:
The hardware and software of the subject Mako System with Mako Total Knee Application is identical to the hardware and software of the predicate Mako System with Mako Total Knee Application. The software modifications being made do not impact the intended use or the fundamental technology of the device. Furthermore, performance testing demonstrates that the characteristics of the subject Mako Total Knee Application are equivalent to the characteristics of the predicate device. The subject 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.