OMNIBotics Knee System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 1, 2017 OMNIlife Science Inc. Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767 Re: K163338 Trade/Device Name: OMNIBotics® Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 18, 2017 Received: August 21, 2017 Dear Christina Rovaldi: 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 devicerelated 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. {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. 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. 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, # Katherine D. Kavlock -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K163338 Device Name OMNIBotics® Knee System #### Indications for Use (Describe) The OMNIBotics® Knee System is indicated for stereotaxic surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular icon on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, lighter blue letters. The green circular icon appears to be an abstract representation of a person in motion. #### 510(k) Summary | Submitter: | OMNIlife Science Inc. | |----------------------|--------------------------------------------------| | Address: | 480 Paramount Drive<br>Raynham, Ma. 02767 | | Phone number: | 800-448-6664 | | Fax number: | 508-822-6030 | | FDA Registration #: | 1226188 | | Contact person: | Christina Rovaldi, Regulatory Affairs Specialist | | Phone number: | 1-774-226-1857 | | Fax number: | 508-822-6030 | | Date prepared: | July 27, 2017 | | Trade name: | OMNIBotics® Knee System | | Classification Name: | Orthopedic Stereotaxic Instrument | | Product Code: | OLO | | Regulation: | 21 CFR 882.4560 | Substantial equivalence claimed to: K090953: TOTAL KNEE SURGETICS Navigation System with IBlock® (Primary Predicate) K150372: VERASENSE Knee System K132104: eLibra® Soft Tissue Force Sensor #### Description: The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and OR staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the iBlock® cutting guide for guiding femoral bone resections, and the Active Spacer, an active (motorized) knee spacer and ligament tensioning device for knee ligament balancing. The OMNIBotics® Station includes a 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the iBlock® and the Active Spacer are contained within a single enclosure, the control box, located at the base of the Station. #### Indications for Use: The OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, blue letters. The circular graphic appears to be an abstract representation of a person in motion. Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants. # Technological Characteristics The underlying technology of the OMNIBotics® Knee System is the same as the predicate device TOTAL KNEE SURGETICS Navigation System with iBlock® K090953. The system is based on the same operating principle and control, mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern the modification of the ART software suite for navigation, and the addition of the Active Spacers for tensioning balance of the knee. | General<br>Characteristic | OMNIBotics® Knee System | TOTAL KNEE SURGETICS<br>Navigation System with iBlock®<br>(K090953) | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The OMNIBotics® Knee System is<br>indicated for stereotaxic surgery to aid<br>the surgeon in locating anatomical<br>structures and aligning endoprostheses<br>with these anatomical structures<br>during Total Knee Arthroplasty. The<br>Active Spacer is indicated as a tool for<br>adjustment of soft tissue and the<br>femoral implant to reduce instability<br>from flexion gap asymmetry. The<br>OMNIBotics® Knee System supports<br>OMNI Apex Knee™ System implants. | The Total Knee Surgetics Navigation<br>System with iBlock® is intended for<br>use stereotaxic surgery to aid the<br>surgeon in locating anatomical<br>structures and aligning the<br>endoprostheses with the anatomical<br>structures.<br>It is specifically indicated for: Total<br>Knee Arthroplasty | | Station | - A 3D optical localizer (OTS camera)<br>- A Microsoft Windows based laptop<br>computer that runs application<br>specific (ART knee) software<br>- One electronics enclosure<br>containing power supplies and<br>communication hardware for the<br>iBlock®, optical camera, and active<br>spacer<br>- 31.5 inch display monitor<br>- A mobile OTS cart | - A 3D optical localizer (OTS camera)<br>- A Microsoft Windows based panel<br>computer that runs application<br>specific (TKS knee) software<br>- Two electronics enclosures<br>containing power supplies and<br>communication hardware for the<br>iBlock®, and optical camera<br>- 17inch display monitor<br>- A mobile custom designed cart | ### Technological Characteristics Compared to Predicate Device: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left, which appears to be an abstract representation of a person in motion. To the right of the graphic is the word "OMNI" in large, bold, dark blue letters. Below "OMNI" are the words "PRECISION IN MOBILITY" in a smaller, sans-serif font, also in dark blue. | General<br>Characteristic | OMNIBotics® Knee System | TOTAL KNEE SURGETICS<br>Navigation System with iBlock®<br>(K090953) | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ART<br>Software: | - Total knee navigation software<br>- based on imageless (CT-free)<br>registration of the knee morphology<br>and leg mechanical axis<br>- Measured resection and ligament<br>balancing profiles<br>- Tibiofemoral gap measurements<br>throughout flexion<br>- Flexible workflows though the use<br>of an onscreen menu<br>- GUI formatted for 16:9 display<br>ratio | - Total knee navigation software<br>- based on imageless (CT-free)<br>registration of the knee morphology<br>and leg mechanical axis<br>- Measured resection and ligament<br>balancing profiles<br>- Tibiofemoral gap measurements<br>throughout flexion<br>- Linear workflows pre-established<br>in user profile preferences<br>- GUI formatted for 5:4 display ratio | | Instruments: | - Rigid bodies equipped with sterile<br>single-use markers<br>- Adjustable cutting guide for tibial<br>cut and/or distal femoral cut | - Rigid bodies equipped with sterile<br>single-use markers<br>- Adjustable cutting guide for tibial<br>cut and/or distal femoral cut | | iBlock®<br>motorized<br>cutting guide | - Universal motorized cutting guide<br>for positioning a saw-guide to the<br>five femoral component resections | - Universal motorized cutting guide<br>for positioning a saw-guide to the<br>five femoral component resections | In addition to the comparison of the core functionality of the OMNIBotics® Knee System to the TOTAL KNEE SURGETICS Navigation System with iBlock®, new features are provided with the OMNIBotics® Knee System through the use of the Active Spacer. The Active Spacer includes two independently controlled actuators for distraction and two force sensors for sensing loads on the medial and lateral compartments of the knee. The actuators are controlled in position control (to apply a controlled height) and in force control (to apply a controlled force, in Newtons), equivalent to the VERASENSE Knee System (K150372) and the eLibra® Soft Tissue Force Sensor (K132104) respectively. In summary, the OMNIBotics® Knee System with the Active Spacer is substantially equivalent to the TKS Navigation System when combined with the Versasense and the eLibra® devices in device functionality and intended use, and safety and effectiveness is supported by the testing performed. # Verification and Validation Documentation The OMNIBotics® Knee System tests include cadaver testing and verification and validation performance testing to demonstrate no new safety and efficacy issues are raised with this new device. Analyses demonstrate that system accuracy and performance are adequate for the established intended use. In conclusion, the modified OMNIBotics® Knee System is substantially equivalent to the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for OMNI Precision in Mobility. The logo consists of a green circular graphic on the left and the word "OMNI" in large, bold, blue letters on the right. Below the word "OMNI" is the phrase "PRECISION IN MOBILITY" in smaller, thinner, blue letters. The green circular graphic appears to be an abstract representation of a person. #### Conclusion: This performance of the OMNIBotics® Knee System is substantially equivalent to that of the TOTAL KNEE SURGETICS Navigation System with iBlock® (K090953) combined with the Versasense position control and the eLibra® force control. The OMNIBotics® Knee System has been demonstrated to be substantially equivalent to the predicate devices and raises no new concerns related to safety or efficacy.