(114 days)
Not Found
No
The summary describes a robotic surgical system that uses pre-operative CT data and software-defined spatial boundaries for guidance. While it uses a "robotic arm" and is described as an "intelligent" tool holder, the description focuses on stereotactic guidance and passive constraint based on pre-defined parameters, not on adaptive learning or data-driven decision-making characteristic of AI/ML. There are no mentions of AI, ML, deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and navigation, and to serve as an "intelligent" tool holder or guide. It does not directly provide therapy to the patient.
No
Explanation: The device is described as assisting a surgeon by providing spatial boundaries for orientation and reference, and by providing stereotactic guidance during surgical procedures. There is no mention of the device providing a diagnosis of a disease or condition.
No
The device description explicitly states that the system includes hardware components such as an optical detector, robotic arm, guidance module, computer, dedicated instrumentation, operating software, tools and accessories, and a cutting system. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist the surgeon during orthopedic procedures by providing spatial boundaries and reference information based on CT data. This is 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 treatment.
- Device Description: The description details a robotic arm, optical detector, computer, and software used for surgical planning and intraoperative navigation. It focuses on assisting the surgeon in preparing the anatomical site for an implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly designed for use during surgical procedures to guide the surgeon's actions based on pre-operative imaging, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The RIO 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
MAKOplasty Total Hip Application is an upgrade to RIO-THA (K121064). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support two main surgical applications: total hip procedures and partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's 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, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:
- RIO arm and MICS communication Test
- MICS Handpiece Functional Test
- MICS Cover Functional Test
- Inline Offset Cup Impactor Thread Connection Functional Test
- MICS Reamer Attachment Functional Test
- RIO Base Array Functional Test
- THA Application Performance Test
- Full System Test
Conclusions of Non-clinical Data:
The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Mako Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K141989
Trade/Device Name: MAKOplasty Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 8, 2014 Received: October 14, 2014
Dear Mr. Reeves:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized blue arc above the word "MAKO" in bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in a smaller, less bold font, also in black. The logo is clean and modern, with the blue arc providing a visual element that suggests movement or technology.
555 Davie Road • Ft. Lauderdale, FL 2044 • Fax 954.927.0 ww.makosurgical.com
INDICATIONS FOR USE
510(k) Number: K141989
Device Name: Total Hip Application (THA)
Indications for Use:
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The RIO 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 O
- o Total hip arthroplasty (THA)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/16 description: The image shows the text "Page 1 of 1" in a large, bold font, indicating that it is the first page of a document. Below this, the text "Section_003_Page38" is displayed, likely referring to a specific section and page number within the document. The text is aligned to the left and appears to be part of a header or footer element.
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Image /page/3/Picture/0 description: The image is a logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below the word "MAKO" is the phrase "SURGICAL CORP." in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.
1555 Davie Road • Ft. Lauderdale, FL 33317 hone 954.927.2044 • Fax 954.927.0446 ww.makosurgical.com
510(K) SUMMARY
Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Device Trade Name: Regulation Name: Regulation Number: Device Classification: Product Code:
MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL 33317 954-628-0655 954-927-0446 Jonathan Reeves July 03, 2014 MAKOplasty Total Hip Application Stereotaxic Instrument 21 CFR 882.4560 Class II OLO
Substantial Equivalence Claimed To: MAKOplasty Total Hip Application is substantially equivalent to MAKO Surgical's (Robotic Arm Interactive Orthopedic System) RIO - (Total Hip Arthroplasty) THA cleared via K121064.
Device Modifications:
- MAKO Integrated Cutting System (MICS)
- Inline offset cup impactor ●
- MICS endcap
- . Reamer attachment
- 4.0mm bone pins
- RIO Base Array
- Reduction Results: hip length and combined offset
Device Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K121064). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support two main surgical applications: total hip procedures and partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical
4
procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's 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 MAKOplasty Total Hip Application compared to the predicate device are listed below:
| Technological
Characteristics | MAKOplasty Total Hip
Application | RIO-THA
(K121064) | |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------|
| 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 instruments | Various reusable instruments |
| | Images Use | CT | CT |
Intended Use/Indications for Use
The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The RIO 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) .
Performance Data:
The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:
- RIO arm and MICS communication Test ●
- MICS Handpiece Functional Test ●
- MICS Cover Functional Test
- Inline Offset Cup Impactor Thread Connection Functional Test
- MICS Reamer Attachment Functional Test
- RIO Base Array Functional Test ●
- THA Application Performance Test ●
- Full System Test ●
Conclusions of Non-clinical Data:
The results of testing indicated the device performed within the intended use and
5
did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
Summary of Design Control Activities:
The risk analysis activities for this device modification include a risk management plan, hazard analysis and Failure Modes and Effects Analysis (FMEAs). Based upon the review of this data and information obtained through verification and validation activities, there are no unacceptable levels of risks that have been identified resulting from the device modification.