(82 days)
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 a surgical hip procedure 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 Hip Arthroplasty (THA)
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.
The provided text is a 510(k) Pre-Market Notification from the FDA regarding the Mako Total Hip Application. It is a clearance document for a medical device that assists surgeons during Total Hip Arthroplasty (THA) procedures through stereotactic/haptic guidance.
However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Specifically, the document states:
- "Performance Data - The Mako System has been evaluated through the following non-clinical performance testing: Software testing, Instrument performance testing, Mako Total Hip Application full system run through, Bone registration accuracy verification, Implant models and visuals verification, Full system cadaver validation, Biocompatibility verification."
- "Conclusions of Performance Testing: Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are 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."
This outlines the types of tests performed and the conclusion of substantial equivalence, but it does not provide the specific numerical acceptance criteria, the reported performance metrics, sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, or details about training sets.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
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February 2, 2020
Mako Surgical Corp. Liza Gordillo Senior Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K193128
Trade/Device Name: Mako Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 8, 2019 Received: November 12, 2019
Dear Liza Gordillo:
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
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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) 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 (QS) 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 medical devices and radiation-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
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Indications for Use
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 Mako System is indicated for use in a surgical hip procedure 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 Hip Arthroplasty (THA)
Type of Use (Select one or both, as applicable)
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/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 wave or mountain range.
555 Davie Road · Ft. Lauderdale, FL 33317 927.2044 • Fax 954.927.0446 ww.makosurgical.com
510(k) SUMMARY
| Sponsor: | Mako Surgical Corp.2555 Davie Road,Fort Lauderdale, FL 33317 |
|---|---|
| Contact Person: | Liza Gordilloliza.gordillo@stryker.comPhone: 954-628-0802 |
| Date Prepared: | November 8, 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 K191998.
Device Modification:
The following changes have been made to the Mako Total Hip Application:
For clarity, reference to surgical knee procedures, including the unicondylar knee replacement and/or patellofemoral knee replacement indication, will be removed from the Mako Total Hip Application Indications for Use.
The MAKO Total Hip Application is being modified to integrate the Direct Superior (DS) approach, add compatibility with additional acetabular implants, enhance implant planning and pelvic registration, implement new features to facilitate user experience, update the starting software interface, and add additional instrumentation.
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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.
| TechnologicalCharacteristics | Mako Total Hip Application | Mako Total Hip Application(K191998) | |
|---|---|---|---|
| MajorComponents | 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 disposableinstruments | Various reusable and disposableinstruments |
CT
Summary of Technological Characteristics Compared to Predicate Devices:
The technological characteristics of the Mako Total Hip Application compared to the
Intended Use/Indications for Use:
Image 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.
CT
The Mako System is indicated for use in a surgical hip procedure 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 Hip Arthroplasty (THA)
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:
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- Software testing ●
- Instrument performance testing ●
- Mako Total Hip Application full system run through ●
- Bone registration accuracy verification
- . Implant models and visuals verification
- Full system cadaver validation ●
- Biocompatibility verification .
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are 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.
§ 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).