(61 days)
No
The summary describes a robotic surgical system for orthopedic procedures that uses CT data for planning and navigation, and a robotic arm for guidance within software-defined boundaries. There is no mention of AI or ML algorithms being used for image processing, decision support, or any other function. The system appears to be based on pre-operative planning and stereotactic guidance, not learning or adaptive capabilities.
No.
The device is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and navigation, and it serves as a tool holder or guide; it does not directly perform therapeutic action on the patient.
No
Explanation: The device is described as assisting a surgeon by providing spatial boundaries and guidance during orthopedic procedures, and acting as a tool holder or guide. It uses CT data for pre-surgical planning and intraoperative navigation. It does not state that it analyzes patient data to diagnose a condition or disease.
No
The device description explicitly states that the system includes hardware components such as an optical detector, robotic arm, guidance module, computer, instrumentation, and a drill system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the RIO system is a robotic arm intended to assist surgeons during orthopedic procedures (knee and hip replacement). It uses CT data for pre-surgical planning and intraoperative navigation, providing spatial boundaries and guidance.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on surgical assistance and guidance based on imaging data and anatomical structures.
The RIO system falls under the category of surgical robots or computer-assisted surgery systems, not 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
OLO
Device Description
MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). 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, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). 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
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)
Performance Data: Unit, Integration and System level testing was performed with the MAKOplasty Total Hip Application with the knee software dually installed in order to evaluate the application's ability to support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement. A summary of the completed design verification and validation activities to support substantial equivalence is as follows:
Verification Testing - All testing Passed
- Partial Knee Application Verification
- System Accuracy
- Full Application Software Runthrough
Validation Testing- Passed
- Total Hip Application Full Cadaver Validation Lab
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
Image /page/0/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles an arrow or a stylized letter "A". At the top of the image is the number "K121064".
t lauderdale, florida 33317
JUN - 6 2012 page i of 2
2555 davie road
tal 954,927
fax 954.927.0446
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 Dionne Sanders April 4, 2012 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 K093425.
Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). 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, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). 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.
1
Image /page/1/Picture/0 description: This image contains the logo for MAKO Surgical Corp. The image also contains the text 'K121064' at the top, and 'Page 7 of 2' on the right side. At the bottom of the image, the address '2555 davie road fort lauderdale, florida 33317' is printed, along with the phone number 'tel 954.927.2044' and fax number 'fax 954.927.0446'.
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
(K093425) |
|----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Major
Components | Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop. | Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop. |
| Tools/accessories | Various reusable instruments | Various reusable instruments |
| Images Use | CT | CT |
Performance Data: Unit, Integration and System level testing was performed with the MAKOplasty Total Hip Application with the knee software dually installed in order to evaluate the application's ability to support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement. A summary of the completed design verification and validation activities to support substantial equivalence is as follows:
Verification Testing - All testing Passed
- Partial Knee Application Verification ●
- . System Accuracy
- Full Application Software Runthrough .
Validation Testing- Passed
- . Total Hip Application Full Cadaver Validation Lab
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 o
- Total hip arthroplasty (THA) 0
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with three arms or lines extending upwards, symbolizing health, services, and humanity. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 6 2012
Mako Surgical Corporation c/o Ms. Dionne Sanders Senior Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K121064
Trade/Device Name: Makoplasty Total Hip Application, RIO Standard System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 8, 2012 Received: May 11, 2012
Dear Ms. Dionne Sanders:
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 10 too barranor 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.
3
Page 2 - Ms. Sanders
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours
for
Nop
OL
Mark N. Melk rson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the logo is a black graphic that resembles an abstract shape. At the top of the image, there is a handwritten text "K121064".
fort lauderdale, florida 33317
tel 954.927.2044
fax 954.927.0446
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MAKOplasty Total Hip Application
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) o
Prescription Use X 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)
Neil R.P. Ogden for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121064