Who is the manufacturer of POINT Kinguide Robotic-Assisted Surgical System?

Point Robotics MedTech, Inc. filed the 510(k) submission for POINT Kinguide Robotic-Assisted Surgical System (K220241).

What is the FDA product code for POINT Kinguide Robotic-Assisted Surgical System?

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

What is the regulatory pathway for POINT Kinguide Robotic-Assisted Surgical System?

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

What are the predicate devices for POINT Kinguide Robotic-Assisted Surgical System?

Stealthstation™ S8 Spine Software v1.3.0 (K201189); StealthStation™ S8 System (K162309); Stealth-Midas System (K160713).

Who can help prepare an FDA 510(k) submission like POINT Kinguide Robotic-Assisted Surgical 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.

POINT Kinguide Robotic-Assisted Surgical System

K220241 · Point Robotics MedTech, Inc. · OLO · Aug 9, 2022 · Neurology

Device Facts

Record ID	K220241
Device Name	POINT Kinguide Robotic-Assisted Surgical System
Applicant	Point Robotics MedTech, Inc.
Product Code	OLO · Neurology
Decision Date	Aug 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

“POINT” Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1).

Device Story

Kinguide Robotic-Assisted Surgical System is an orthopedic stereotaxic device; consists of hand-held robot, passive arm, workstation, infrared navigation camera, navigation software, C-arm ring calibrator, and surgical accessories. Input: patient images (CT) and real-time spatial positioning data from infrared camera tracking Dynamic Reference Frames (DRFs) on patient and tools. Workstation processes data to register patient anatomy to images; establishes surgical navigation map. Surgeon uses hand-held robot, supported by passive arm, to find surgical trajectories; robot provides high-precision positioning for instruments. Used in OR; operated by surgeons. Output: visual navigation map on workstation display; physical guidance for instrument placement. Benefits: increased precision in locating anatomical structures; stable movement; prevention of unexpected instrument drops.

Clinical Evidence

No clinical data. Evidence based on bench testing and cadaveric validation. Performance testing included positional accuracy verification (mean positional error ≤2.0 mm, mean trajectory error ≤2°), human factors/usability engineering (IEC 62366-1), product safety (IEC 60601 series), biocompatibility (ISO 10993-1), and environmental/mechanical stress testing (ASTM/IEC standards).

Technological Characteristics

Orthopedic stereotaxic system. Components: hand-held robot, passive arm, workstation (Intel-based PC), infrared navigation camera (Northern Digital Vega). Connectivity: DICOM import via CD/DVD/USB. Software: C++ based. Accuracy: ≤2.0 mm positional, ≤2° trajectory. Sterilization: Reusable accessories validated per AAMI TIR30/TIR12. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-77, ASTM F2554-18, ASTM F3107-14.

Indications for Use

Indicated for patients requiring stereotactic spinal surgery where rigid anatomical structures can be identified via imaging. Specifically indicated for posterior pedicle screw implantation in lumbar (L1-L5) or sacral (S1) vertebrae.

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

Stealthstation™ S8 Spine Software v1.3.0 (K201189)
StealthStation™ S8 System (K162309)
Stealth-Midas System (K160713)

Related Devices

K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System · Point Robotics MedTech, Inc. · Jan 23, 2026
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application · Medtronic Navigation, Inc. · Feb 12, 2026
K192173 — ROSA ONE Spine application · Medtech S.A · Oct 29, 2019
K171651 — EXCELSIUS GPS · Globus Medical, Inc. · Aug 16, 2017
K201569 — CUVIS-spine · Curexo, Inc. · May 19, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ August 9, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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. Point Robotics MedTech Inc. Wayne Kao, Director 7F., No.219, Sec.3, Beixin Rd., Xindian Dist. New Taipei City, 231 Taiwan ### Re: K220241 Trade/Device Name: "POINT" Kinguide Robotic-Assisted Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 25, 2022 Received: d- #### Dear Mr. Wayne Kao: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K220241 Device Name "POINT" Kinguide Robotic-Assisted Surgical System Indications for Use (Describe) "POINT" Kinguide Robotic-Assisted System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1). Type of Use (*Select one or both, as applicable*): | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ### 510(k) Summary January 13, 2022 ### 1. Submitter's Information #### Submission Submitter | Company Name | Point Robotics MedTech Inc. | |----------------|-------------------------------------------------------------------------------| | Address | 7F., No.219, Sec.3, Beixin Rd., Xindian Dist., New Taipei City 231, Taiwan | | Contact Person | Mr. Wayne Kao | | Phone | 866-2-29130272#165 | | Email | wayne.kao@pointroboticsinc.com | | Proprietary/Trade Name | “POINT” Kinguide Robotic-Assisted Surgical System | |------------------------|---------------------------------------------------| | Regulation Name | Stereotaxic Instrument | | Regulation Number | 882.4560 | | Product Code | OLO | | Device Classification | II | | Review Panel | Orthopedic | ### 2. Subject Device Information # 3. Device Description "POINT" Kinguide Robotic-Assisted Surgical System (Kinguide Surgical System) is an orthopedic stereotaxic medical device, which consists of a hand-held robot, a passive arm, a workstation, an infrared navigation camera, navigation software, C-arm ring calibrator and surgical navigation accessories. Among them, the workstation, as the main console for controlling the hand-held robot, is equipped with a computer and control modules, which performs all operations in the surgical procedure through the computer, and transmits its information to the control modules for controlling movements of the hand-held robot. The C-arm ring calibrator and the navigation probe are used to perform registration process. The infrared navigation camera receives the spatial positioning of the patients, the hand-held robot and the surgical accessories through Dynamic Reference Frames (DRFs), and in the meantime the camera sends the data back to the workstation for monitoring stereotactic surgical operation. The Kinguide Surgical System can assist surgeons to find surgical trajectories quickly and precisely during surgical operations. Software application in the system provides the {4}------------------------------------------------ patient's image to match coordinates of the patient's anatomical structure, and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map with navigable tools. # 4. Indications for Use "POINT" Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to images of the anatomy. The indications include medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1). # 5. Identification of Legally Marketing Devices K201189 - StealthstationTM S8 Spine Software v1.3.0 K162309 - StealthstationTM S8 System Platforms and StealthStation Cranial Software K160713 - Stealth-Midas System {5}------------------------------------------------ # 6. Comparison to the Predicate Device | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | “POINT” Kinguide Robotic-Assisted | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | Surgical System | | | | | | | | | | | K number | N/A | K201189 | K162309 | K160713 | | Product Code | OLO | OLO | HAW, OLO, PGW | OLO | | Intended Use & Indications for Use | “POINT” Kinguide Robotic-Assisted Surgical System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where | The StealthStation™ System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid | The StealthStation™ System, with StealthStation Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous surgical procedures. The StealthStationTM System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid | The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal surgical procedures. Computer- assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of | | | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | Item | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | reference to a rigid anatomical structure can be identified relative to images of the anatomy. The indications include all medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1). | anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include, but is not limited to, the following procedures: • Pedicle Screw Placement • Iliosacral Screw Placement • Interbody Device Placement | anatomical structure, such as the skull, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR- based model, fluoroscopic images, or digitized landmarks of the anatomy. | | | System Accuracy Requirement | According to verification and validation results, "POINT" Kinguide Robotic-Assisted Surgical System has demonstrated performance in 3D | Under representative worst-case configuration, the StealthStation S8 Spine software v1.3.0, has demonstrated performance in 3D positional accuracy with a mean positional | Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial v1.0.0 Software, has demonstrated performance in 3D | | | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | Item | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | positional accuracy with a mean positional error of $\leq$ 2.0 mm and mean trajectory error of $\leq$ 2 degrees. | error of $\leq$ 2.0 mm and mean trajectory error of $\leq$ 2 degrees. Mean Accuracy Values (StealthAiR Spine): Positional Error – 1.01 mm Trajectory Error – 0.37 degrees Mean Accuracy Values (Overlapping Slices): Positional Error - 0.51 mm Trajectory Error -0.41 degrees | positional accuracy with a mean error $\leq$ 2.0 mm and in trajectory angle accuracy with a mean error $\leq$ 2.0 degrees. | | | Imaging Modalities | X-Ray based (CT) | X-Ray Based Imaging | X-Ray based, MR based Nuclear Medicine based | Identified relative to a CT- or MR-based model | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | | “POINT” Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | Surface Matching Registration Image Landmark Registration Precise Surface Registration Image Registration | PointMerge Registration SurfaceMerge Registration FluoroMerge Registration Automatic 2D Image Registration Automatic 3D Image Registration StealthAiR Spine Automatic Registration | PointMerge® registration (referred to as Landmark registrations) Tracer™ registration Touch registration (previously Touch-N-Go™) StealthAiR® registration, O-arm® registration, Mechanical based registrations (Stereotactic Localizer Registration and StarFix™ Bone Anchor Registration) | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | | Registration Features | | | | | | | | | | | Planning Features | Plan Entry and Target Selection 3D Model Building | Plan Entry and Target Selection 3D Model Building Deformity Planning | Plan Entry and Target selection 3D Model Building Advanced Visualization | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | Medical Device Interfaces | “POINT” Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | Siemens Arcadis Varic C- Arm Siemens Arcadis Orbic C-Arm | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm ISO-C 3D C-Arm Ziehm Vision RFD 3D C-arm Stealth-Midas MR8 Orbic 3D C-Arm | Microscope Navigation: Zeiss, Leica Ultrasound Navigation: Aloka and Sonosite Medtronic O-arm® Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell Nexframe® Stereotactic System STarFix™Platform System | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | | View/Display Features | Look Sideways 3D View Anatomic Orthogonal Trajectory 1 and 2 Trajectory Guidance Probe's Eye AP and Lateral | Look Sideways 3D Anatomic Orthogonal Trajectory 1 and 2 Trajectory Guidance Look Ahead Probe's Eye | Ultrasound Video In, Ultrasound Overlay, 3D, 2D Anatomic Orthogonal, Trajectory 1 and 2, Target Guidance, Trajectory Guidance, Probes Eye, | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | “POINT” Kinguide Robotic-Assisted Surgical System | | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | Maximum Intensity Projection | AP and Lateral Synthetic AP and Lateral Maximum Intensity Projection Video Input | Look Ahead, Microscope Injection, Video Input, Endoscopic | | | Software Interface (GUI) | User friendly interface with procedure task overview at home page. System tools for image adjustment, surgical planning and instrument management are contained in a left-side bar. The system information is shown on the right-side bar. | Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a right- side bar. | Black and gray style with procedure task overview in left menu option and next/back task flow at bottom of the screen. Software controls for images, planning and instrument management are contained in a right- side bar. | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | Programming Language | C++ | C++ | C++ | Stealth-Midas integrates seamlessly with StealthStation surgical | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | | | | | | | navigation solutions. | | Scanner Interface Technology (to imaging devices) | CD, DVD, USB DICOM Import | Network Connectivity CD, DVD, USB DICOM Import DICOM Export | Network Connectivity CD, DVD, USB DICOM Import DICOM Export | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | Localization Technology | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | Optical (infra-red) Manufacturer: Northern Digital Localizer: Vega | | Computer Platform | Intel-based PC | Intel-based PC | Intel-based PC | Stealth-Midas integrates seamlessly with StealthStation surgical navigation solutions. | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | “POINT” Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0 | StealthStation™ S8 System | Stealth-Midas System | | | Drill System | The Kinguide Surgical System has a hand-held robot. The hand-held robot can be identified by the infrared navigation camera through the Robotic Base Frame (BF). It has high freedom of operation and high- precision positioning ability. It is used to position the surgical instrument connected to the end-effector of the robot. | Not Applicable | Not Applicable | The Stealth-Midas™ is a high-speed drill with a permanently attached tracker that allows for intraoperative navigation of spinal procedures using the StealthStation™ surgical navigation system. | | Mechanical Support | A passive arm of this system is applied to support the hand-held robot during surgeries. It | Not Applicable | Not Applicable | A standard handpiece drill with a permanently attached tracker. | | Item | Subject Device | Software Predicate | Platform Predicate | Drill System Predicate | | | "POINT" Kinguide Robotic-Assisted Surgical System | Stealthstation™ S8 Spine Software v1.3.0…