(94 days)
Not Found
No
The description focuses on stereotactic surgery, robotic assistance, and haptic guidance based on CT data and pre-surgical planning, without mentioning AI or ML. The "intelligent" tool holder description refers to software-defined spatial boundaries, not AI/ML capabilities.
No.
A therapeutic device is one that directly treats or alleviates a medical condition. This device is described as assisting the surgeon during orthopedic procedures by providing spatial boundaries and navigational guidance, rather than directly treating the condition itself. It's a surgical tool that aids in the procedure, but it is not the therapy.
No
The device is a surgical assistance system that provides stereotactic/haptic guidance and assists with pre-surgical planning and implant placement during orthopedic procedures. It does not diagnose medical conditions.
No
The device description explicitly states that the MAKO System includes hardware components such as a robotic arm, integrated cutting system, optical detector, and computer, in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the MAKO System with the Partial Knee Application clearly states its purpose is to assist surgeons during orthopedic procedures by providing spatial boundaries and guidance based on patient CT data. It interacts directly with the patient's anatomy during surgery, not with samples taken from the patient.
- The intended use is for surgical assistance. The indications for use and device description focus on aiding the surgeon in planning and performing knee replacement procedures. This is a surgical tool, not a diagnostic test performed on a specimen.
The device is a surgical planning and guidance system that utilizes imaging data (CT) to assist in a surgical procedure. This falls under the category of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
• Restoris Multicompartmental Knee System
Product codes
OLO
Device Description
The MAKO System with the Partial 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 svstem 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)
The MAKO System has been evaluated through the following non-clinical performance testing:
- Cutting Accuracy Verification
- Cadaver Validation of Mako System with New Burr
- Biocompatibility Evaluation
Conclusions of Performance Testing: The results of the performance testing demonstrate that the characteristics of the MAKO Partial Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate and does not raise new 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
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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November 2, 2017
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MAKO Surgical Corp. Andrea Steiner Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K172301
Trade/Device Name: Mako Partial Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 29, 2017 Received: October 3, 2017
Dear Andrea Steiner:
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 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.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
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
510(k) Number (if known)
Device Name
Mako Partial Knee Application
Indications for Use (Describe)
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
• Restoris Multicompartmental Knee System
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 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, stylized shape that resembles a wave or a mountain range.
Ft. Lauderdale, FL 044 · Fax 954.927.0 ww MAKOsurgical com
510(K) SUMMARY
Sponsor:
MAKO Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317
Contact Person:
Andrea Dwyer Steiner, MS Andrea.Steiner@stryker.com Phone: 954-628-0735 Fax: 954-927-0446
Date Prepared: July 28, 2017
Proprietary Name: MAKO Partial Knee Application
Common Name: Partial Knee Application (PKA)
Regulation Name: Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Device Classification: Class II
Product Code: OLO
Substantial Equivalence Claimed To:
The MAKO Partial Knee Application is substantially equivalent to MAKO Surgical's Partial Knee Application cleared via K170891.
Device Modifications: The following changes have been made to the MAKO Partial Knee Application:
- MICS Cutting Attachment – Addition of a 6mm burr. The burr will be used for cutting and bone resection prior to implant placement for partial knee arthroplasties
Description:
The MAKO System with the Partial 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 svstem 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 Partial Knee
Application | MAKO Partial Knee Application
(K170891) |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 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 Partial Knee Application compared to
Intended Use/Indications for Use:
the predicate device are listed below:
The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with 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 unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
• Restoris Multicompartmental Knee System
Performance Data - The MAKO System has been evaluated through the following non-clinical performance testing:
5
- Cutting Accuracy Verification ●
- Cadaver Validation of Mako System with New Burr ●
- Biocompatibility Evaluation .
Conclusions of Performance Testing:
The results of the performance testing demonstrate that the characteristics of the MAKO Partial Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate and does not raise new questions of safety and effectiveness, and therefore supports a determination of Substantial Equivalence.