Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System

Q: Who is the manufacturer of Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System?

Stryker Leibinger GmbH & Co KG filed the 510(k) submission for Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (K233542).

Q: What is the FDA product code for Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System?

Ortho Guidance Precision Knee Software (K223767); Ortho Guidance Express Knee Software (K223767); Ortho Guidance Versatile Hip Software (K223767); Q Guidance System (K212194).

Q: Who can help prepare an FDA 510(k) submission like Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K233542 · Stryker Leibinger GmbH & Co KG · OLO · Mar 14, 2024 · Neurology

Device Facts

Record ID	K233542
Device Name	Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
Applicant	Stryker Leibinger GmbH & Co KG
Product Code	OLO · Neurology
Decision Date	Mar 14, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

Ortho Guidance Precision Knee Software: The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Express Knee Software: The Stryker guidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Versatile Hip Software: The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) - Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery - Revisions Q Guidance System: The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

Device Story

System provides planning and intraoperative guidance for open/percutaneous orthopedic surgery. Uses active optical tracking: infrared light emitted by instrument-mounted diodes sensed by platform navigation camera. Computes position/orientation of surgical instruments relative to patient anatomy (pelvis/leg) via intraoperative survey. Displays navigational data and planned items on monitor for surgeon. Operated by trained clinical staff in OR. Assists in precise positioning of instruments, implants, and bony tissue. Benefits include enhanced surgical precision and guidance during arthroplasty and revisions.

Clinical Evidence

No clinical testing was performed. Device performance was established through non-clinical design verification and validation, including cadaver labs and simulated use testing.

Technological Characteristics

Active optical tracking system using infrared light and stereo camera arrays. Platform runs on Linux (Yocto Distro 3.1). Hardware includes Intel Xeon/Core processors, NVIDIA RTX graphics, and specialized framegrabber cards. Connectivity via Ethernet and WiFi (TP-Link USB adapter). User interface includes 32" surgeon monitor and 15.6" touch monitor. System is non-patient contacting and non-sterile.

Indications for Use

Indicated for patients requiring computer-assisted orthopedic surgery of the knee or hip, including Total Hip Arthroplasty and revisions, where reference to rigid anatomical structures (femur, tibia, pelvis) is required.

Regulatory Classification

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.

Predicate Devices

Ortho Guidance Precision Knee Software (K223767)
Ortho Guidance Express Knee Software (K223767)
Ortho Guidance Versatile Hip Software (K223767)
Q Guidance System (K212194)

Related Devices

K223767 — Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System · Stryker Leibinger GmbH & Co KG · Feb 13, 2023
K153240 — Styrker OrthoMap Express Knee System · Stryker Corporate · Jul 7, 2016
K162937 — Stryker OrthoMap Versatile Hip System · Stryker Corporation · Feb 23, 2017
K072267 — TOTAL HIP SURGETICS NAVIGATION SYSTEM · Praxim S.A · Dec 10, 2007
K242009 — 360CAS Knee · Kico Knee Innovation Company Pty, Ltd. · Aug 8, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ March 14, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. Stryker Leibinger GmbH & Co. KG Megan Guilbault Staff Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttemberg, D-79111 Germany # Re: K233542 Trade/Device Name: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2023 Received: December 15, 2023 Dear Megan Guilbault: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ # K233542 - Megan Guilbault (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S 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 {2}------------------------------------------------ # Indications for Use Submission Number (if known) K233542 Device Name Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System Indications for Use (Describe) Ortho Guidance Precision Knee Software: The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Express Knee Software: The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. Ortho Guidance Versatile Hip Software: The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. The system is indicated for the following surgical procedures: - Total Hip Arthroplasty (THA) - Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery - Revisions Q Guidance System: The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified. 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### Submitter Information ### 1.0 This Premarket Notification is submitted by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany ### 2.0 Contact Information | Contact name: | Megan Guilbault | |---------------------|-----------------------------| | Cellular Telephone: | (401) 241-6152 | | Email: | megan.guilbault@stryker.com | | Date Prepared: | March 14, 2024 | #### 3.0 Device Name | Subject (Modified) Device Information | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/ Proprietary Name | Ortho Guidance Precision Knee Software Ortho Guidance Express Knee Software Ortho Guidance Versatile Hip Software Stryker Q Guidance System | | Common Name | Stereotaxic Instruments | | Classification | Class II | | Classification Product Code | OLO | | Classification Name | Orthopedic Stereotaxic Instrument | | Classification Regulation | 21 CFR 882.4560 | | Review Panel | Orthopedic | ### Table 1: Device Name #### 5.0 Predicate Devices The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k). The primary predicate device is K223767. | Table 2: Predicate Device List | | | | | |----------------------------------------------|----------------------------------------------|---------|-----------------|------------------------------------| | Subject Device | Predicate Device Trade Name | 510(k) | Product Code | Manufacturer | | Ortho Guidance Precision Knee Software | Ortho Guidance Precision Knee Software | K223767 | OLO | Stryker Leibinger GmbH & Co. KG | | Ortho Guidance Express Knee Software | Ortho Guidance Express Knee Software | K223767 | OLO | Stryker Leibinger GmbH & Co. KG | | Ortho Guidance Versatile Hip Software | Ortho Guidance Versatile Hip Software | K223767 | OLO | Stryker Leibinger GmbH & Co. KG | | Q Guidance System | Q Guidance System | K212194 | HAW | Stryker Leibinger GmbH & Co. KG | {5}------------------------------------------------ #### 6.0 Device Description The purpose of this Traditional 510(k) submission is to seek clearance for the addition of a Stryker guidance system to the indications of 3 Ortho Guidance software applications. The subject devices in scope of this submission are outlined in Table 1 with the predicate information in Table 2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the O Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission. The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg. #### 6.6 Indications for Use #### 6.6.1 Ortho Guidance Precision Knee Software The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. ### 6.6.2 Ortho Guidance Express Knee Software The Stryker guidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate. #### 6.6.3 Ortho Guidance Versatile Hip Software The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate. {6}------------------------------------------------ The system is indicated for the following surgical procedures: - -Total Hip Arthroplasty (THA) - Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery - Revisions - ## 6.6.4 Stryker Q Guidance System The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified. #### 6.7 Comparison of Technological Characteristics A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in the tables below. #### 6.7.1 Technological Comparison between the Ortho Guidance Precision Knee Software and its predicate The technological comparison between the subject device (Ortho Guidance Precision Knee Software) and the predicate device (Ortho Guidance Precision Knee Software) is included in Table 3 below. The predicate received clearance per 510(k) number K223767. | | Predicate Subject Device: Ortho Guidance Precision Knee Software | Predicate Device: Ortho Guidance Precision Knee Software (K223767) | Changes | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Item | | | | | Platform Compatibility | Stryker Ortho Q Guidance System Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System | | Compatible Operating System | Linux (Yocto Distro Version 3.1, codename "dunfell"). | Linux (Yocto Distro Version 3.1, codename "dunfell"). | No change | | Workflow Steps | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | No change | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | No change | #### Table 3: Technological Comparison between the Ortho Guidance Precision Knee Software and its Predicate {7}------------------------------------------------ | Operating Principle | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | No change | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Control Mechanism | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function. | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function. | No change | | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | No change | | Intended Users | Trained clinical staff | Trained clinical staff. | No change | | Graphical User Interface (GUI) | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | No change | | User Interface | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | No change | #### 6.7.2 Technological Comparison between the Ortho Guidance Express Knee Software and its predicate The technological comparison between the subject device (Ortho Guidance Express Knee Software) and the predicate device (Ortho Guidance Express Knee Software) is included in Table 4 below. The predicate received clearance per 510(k) number K223767. {8}------------------------------------------------ - | Item | Subject Device: Ortho Guidance Express Knee Software | Predicate Device: Ortho Guidance Express Knee Software (K223767) | Changes | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Platform Compatibility | Stryker Ortho Q Guidance System Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System | | Compatible Operating System | Linux (Yocto Distro Version 3.1, codename "dunfell"). | Linux (Yocto Distro Version 3.1, codename "dunfell"). | No change | | Workflow Steps | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | No change | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | No change | | Operating Principle | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | No change | | Control Mechanism | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function. | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function. | No change | | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | No change | | Intended Users | Trained clinical staff | Trained clinical staff | No change | | Graphical User Interface (GUI) | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | No change | | User Interface | Surgeon's Monitor Small Touch Monitor Mouse | Surgeon's Monitor Small Touch Monitor Mouse | No change | | Table 4: Technological Comparison between the Ortho Guidance Express Knee Software and its | |--------------------------------------------------------------------------------------------| | Predicate | {9}------------------------------------------------ | | Buttons on active optical instruments | | | |---------------------------|---------------------------------------|---------------------|-----------| | Tracking Signal Output | Visual and auditory | Visual and auditory | No change | #### 6.7.3 Technological Comparison between the Ortho Guidance Versatile Hip Software and its predicate The technological comparison between the subject device (Ortho Guidance Versatile Hip Software) and the predicate device (Ortho Guidance Versatile Hip Software) is included in Table 5 below. The predicate received clearance per 510(k) number K223767. #### Table 5: Technological Comparison between the Ortho Guidance Versatile Hip Software and its Predicate | | Item | Subject Device: Ortho Guidance Versatile Hip Software | Predicate Device: Ortho Guidance Versatile Hip Software (K223767) | Changes | |--|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | | Platform Compatibility | Stryker Ortho Q Guidance System Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System | | | Operating System | Linux (Yocto Distro Version 3.1, codename "dunfell"). | Linux (Yocto Distro Version 3.1, codename "dunfell"). | No change | | | Workflow Steps | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant | No change | | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | No change | | | Operating Principle | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor | No change | | | Control Mechanism | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function | From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function | No change | {10}------------------------------------------------ | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | No change | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Intended Users | Trained clinical staff | Trained clinical staff. | No change | | Graphical User Interface (GUI) | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics. | No change | | User Interface | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | No change | | Tracking Signal Output | Visual and auditory | Visual and auditory | No change | #### Technological Comparison between the Stryker Q Guidance System and its 6.7.4 predicate The technological comparison between the subject device (Styker Q Guidance System) and the predicate device (Stryker Q Guidance System) is included in Table 6 below. The predicate received clearance per 510(k) number K212194. | Table 6-6: Technological Comparison between the Stryker Q Guidance System and Stryker Q Guidance System | | | |---------------------------------------------------------------------------------------------------------|--|--| | | | | | Item | Subject Device: | Predicate Device: | Changes | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Stryker Q Guidance System | Stryker Q Guidance System (K212194) | | | Operating Principle | The software is installed on the • computer that is part of the platform Images are imported in • DICOM format The software displays images • and planned items with navigational information on a monitor | The software is installed on the • computer that is part of the platform Images are imported in DICOM • format The software displays images • and planned items with navigational information on a monitor | Identical - the Ortho Guidance Software applications are imageless and do use the image import functionality that is available on the Q Guidance System. | | Dimensions | Outer dimensions: • Length x Width x Height: 950 x 720 x 1950 mm • Weight: 265 kg | Outer dimensions: • Length x Width x Height: 950 x 720 x 1950 mm • Weight: 265 kg | No change | | Environmental Conditions | Operation: • Temperature: 10°C – 30°C • Relative humidity: 30% – 75% • Atmospheric pressure: 70 kPa – 106 kPa Transportation: • Temperature: -10°C – 50°C • Relative humidity: 10% – 90% • Atmospheric pressure: 70 kPa – 106 kPa Storage: • Temperature: 10°C – 50°C • Relative humidity: 10% – 85% | Operation: • Temperature: 10°C – 30°C • Relative humidity: 30% – 75% • Atmospheric pressure: 70 kPa – 106 kPa Transportation: • Temperature: -10°C – 50°C • Relative humidity: 10% – 90% • Atmospheric pressure: 70 kPa – 106 kPa Storage: • Temperature: 10°C – 50°C • Relative humidity: 10% – 85% | No change | | | | | | | Atmospheric pressure: 70 kPa – 106 kPa | Atmospheric pressure: 70 kPa – 106 kPa | No change | | | WiFi Connectivity TP-Link Archer T9UH, WiFi-USB - Adapter/Dongle | TP-Link Archer T9UH, WiFi-USB - Adapter/Dongle | No change | | | Cable Guard Spatula front mounted design | Spatula front mounted design | No change | | | Cart Castors Keyboard and Mouse | Man & Machine Petite Mouse Medical grade mini mouse; silicon covered; can be disinfected ActiveKey, Medical grade keyboard; silicone covered; can be disinfected | Man & Machine Petite Mouse Medical grade mini mouse; silicon covered; can be disinfected ActiveKey, Medical grade keyboard; silicone covered; can be disinfected | No change | | Application PC | Mainboard: MB-815-00A1E; Advantech Standard Server Board Intel Xeon 4109T Silver 8 Cores, 16 Threads Base Clock 2 GHz / Boost Clock 3 GHz 11 MB L3 Cache RAM 16 GB DDR4 2400MHz Memory: SQF SSD, M.2 480 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm Graphics Card: Leadtek RTX3060 12GB RAM Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital framegrabber DVP-7013E; analog framegrabber 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card 968AD00483; USB to RS422 converter module | Mainboard: MB-815-00A1E; Advantech Standard Server Board Intel Xeon 4109T Silver 8 Cores, 16 Threads Base Clock 2 GHz / Boost Clock 3 GHz 11 MB L3 Cache RAM 16 GB DDR4 2400MHz Memory: Liteon SSD, M.2 256 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm Graphics Card: Leadtek Winfast RTX2070, 8GB RAM Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital framegrabber DVP-7013E; analog framegrabber 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card 968AD00483; USB to RS422 converter module | No change No change Similar No change | | RFID Reader Optical Drive | Omnikey 5127CK-Mini, 13.56 MHz Lite-On Slim 8X SATA DVD+/-RW Dual Layer | Omnikey 5127CK-Mini, 13.56 MHz Lite-On Slim 8X SATA DVD+/-RW Dual Layer | No change | | RealTime PC | Mainboard AIMB-275G2-00A1E; Advantech Standard Mini ITX Board CPU Intel Core i7-7700T 4 Cores, 8 Threads Base clock 2.9 GHz / Boost clock 3.8 GHz 8 MB Smart Cache | Mainboard AIMB-275G2-00A1E; Advantech Standard Mini ITX Board CPU Intel Core i7-7700T 4 Cores, 8 Threads Base clock 2.9 GHz / Boost clock 3.8 GHz 8 MB Smart Cache | No change | | | 16 GB DDR4 2400MHz Extension Cards | 16 GB DDR4 2400MHz Extension Cards | | | | Advantech DMS-IR06 dual port LAN card | Advantech DMS-IR06 dual port LAN card | | | Power Supply | Zippy DHG2-5600V, 600W, 48V-DC | Zippy DHG2-5600V, 600W, 48V-DC | No change | | Operating System | Linux (Yocto Distro Version 3.1, codename "dunfell"). | Linux (Yocto Distro Version 3.1, codename "dunfell"). | No change | | Surgeon's Monitor | Connect via HDMI interface Multi Touch functionality AG80 anti-glare coating 32" | Connect via HDMI interface Multi Touch functionality AG80 anti-glare coating 32" | No change | | Small Touch Monitor | Connected via Display Port interface (DP) 15.6" Touch display AG80 anti-glare coating No DVD-RW drive No integrated RFID reader No integrated power On/Off button No integrated LED indicators No integrated virtual keyboard | Connected via Display Port interface (DP) 15.6" Touch display AG80 anti-glare coating No DVD-RW drive No integrated RFID reader No integrated power On/Off button No integrated LED indicators No integrated virtual keyboard | No change | | PowerBox | XP-Power Custom Design AC/DC power supplies (5V, 24V, 48V) Battery with 9000mAh System can operate without battery | XP-Power Custom Design AC/DC power supplies (5V, 24V, 48V) Battery with 9000mAh System can operate without battery…