Who is the manufacturer of Remi Robotic Navigation System?

Fusion Robotics, LLC filed the 510(k) submission for Remi Robotic Navigation System (K223070).

What is the FDA product code for Remi Robotic Navigation 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 Remi Robotic Navigation System?

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

Who can help prepare an FDA 510(k) submission like Remi Robotic Navigation 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.

Remi Robotic Navigation System

K223070 · Fusion Robotics, LLC · OLO · Oct 28, 2022 · Neurology

Device Facts

Record ID	K223070
Device Name	Remi Robotic Navigation System
Applicant	Fusion Robotics, LLC
Product Code	OLO · Neurology
Decision Date	Oct 28, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The Remi™ Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider® Spinal System.

Device Story

REMI Robotic Navigation System; image-guided surgical system for lumbar pedicle screw placement. Inputs: 3D intraoperative imaging (Medtronic O-arm, GE OEC 3D C-arm, Ziehm FD Vision 3D, Stryker Airo 3D). Operation: Camera tracks surgical site via iliac crest pin; targeting platform provides trajectory guidance. Surgeon performs manual gross positioning; system performs fine-tuned automatic trajectory setting. Output: Real-time visual display of instrument position relative to patient anatomy. Used in OR by surgeons. Benefits: Precise anatomical localization and tool orientation for spinal instrumentation. Compatible with Accelus LineSider Spinal System.

Clinical Evidence

Bench testing only. Verification included 3D imager accuracy software testing and usability validation. Testing confirmed equivalence of GE OEC 3D C-arm, Stryker Airo, and Ziehm Vision 3D C-arm to the predicate Medtronic O-arm regarding image quality, transfer/registration speed, and registration accuracy.

Technological Characteristics

Optical-based navigation system; infrared camera; multi-functional mechanical support arms; targeting platform with tool guide. PSIS pins constructed of titanium (Ti6Al4V ELI per ASTM F136). Connectivity: Workstation-based image processing and registration. Software-controlled trajectory platform with force-limited movement (ceases at >9lbs).

Indications for Use

Indicated for assisting surgeons in placing pedicle screws in the posterior lumbar region (L1-S1) in patients in the prone position during open or percutaneous spinal procedures.

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

Practical Navigation Surgical Guidance System (K202184)

Reference Devices

GE OEC 3D C-arm (K203346)
Stryker Airo 3D (K160126)
Ziehm Vision 3D C-arm (K202360)
Accelus LineSider Spinal System (K190360)

Related Devices

K223350 — Remi Robotic Navigation System · Fusion Robotics, LLC · Mar 13, 2023
K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) · Alphatec Spine, Inc. · Feb 19, 2026
K222698 — CUVIS-spine · Curexo, Inc. · Oct 7, 2022
K232413 — Fusion Robotic Navigation System · Alphatec Spine, Inc. · Sep 8, 2023
K201569 — CUVIS-spine · Curexo, Inc. · May 19, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. October 28, 2022 Fusion Robotics, LLC % Sarah Braun Senior Regulatory Affairs Specialist Integrity Implants Inc. dba Accelus 354 Hiatt Drive Palm Beach Gardens, Florida 33418 Re: K223070 Trade/Device Name: REMI Robotic Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 29, 2022 Received: September 30, 2022 Dear Sarah Braun: 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. {1}------------------------------------------------ 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 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K223070 Device Name REMITM Robotic Navigation System #### Indications for Use (Describe) The REMI™ Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The REMI™ Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in the posterior lumbar region (LI-S1). The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Accelus LineSider® Spinal System. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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 | 510(k) Owner | Fusion Robotics, LLC 168 Centennial Parkway, Unit 170 Louisville, CO 80027 USA | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------| | Contact Person | Sarah Braun Senior Regulatory Affairs Specialist Tel: 423-838-4454 Email: sbraun@accelusinc.com | | Date Prepared | 10/28/2022 | | Classification Reference | 21 CFR 882.4560 | | Product Code | OLO | | Common/Usual Name | Stereotaxic Instrument | | Trade/Proprietary Name Predicate Device(s) | Remi Robotic Navigation System Practical Navigation Surgical Guidance System (K202184) | The Remi Robotic Navigation System (Remi) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The system operates in a similar manner to other optical-based image y systems: - 1. The patient is placed in the appropriate position on the OR table. - 2. The compact tracking Camera is rigidly affixed to the OR table using a multi-functional mechanical support arm in the appropriate position to track the surgical site. - 3. The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy. - 4. The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site. - 5. TThe Registration Array is affixed to the Targeting Platform and positioned over the planned surgical site. {4}------------------------------------------------ - 6. The appropriate area of spine (L1-S1) is scanned with a validated 3D imaging system. - 7. The scans are transferred to the Remi system workstation, which reconstructs the images and uses the registration array image to register the patient's spine relative to the Camera location. - 8. The registration is confirmed by placing an image guided instrument with an Instrument Tracker at various points in the surgical field. - 9. The surgical paths are planned on the workstation. - 10. The Targeting Platform is gross-positioned manually close to the first surgical plan location. - 11. The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan. - 12. Instruments with tracking arrays can now be used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw. # Intended Use/Indications for Use The Remi™ Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider® Spinal System. #### Substantial Equivalence The proposed Remi Robotic Navigation System (Remi) is considered substantially equivalent to the Remi Surgical Guidance System that was cleared as the Practical Navigation Surgical Guidance System (K202184). A comparison to the predicate device is provided in the table below. | Devices | Subject Device Remi Robotic Navigation System | Predicate Device Practical Navigation Surgical Guidance System [K202184] | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or | The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous | | | percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D Imaging scan. The REMI Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (LI-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider Spinal System. | spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a O-arm scan. The REMI Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (LI- S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider Spinal System. | | Product Code | OLO | OLO | | Principles of Operation | Same as Predicate. | Intraoperative/preoperative images Patient registration Surgical planning Real-time tracking of navigated instruments Guidance of instruments | | Input Images | 3D Intraoperative images Medtronic O-arm GE OEC 3D C-arm Ziehm FD Vision 3D Stryker Airo 3D | 3D Intraoperative images Medtronic O-arm | | Trajectory planning parameters | Same as Predicate. | Entry point, target point, length of the instrument, diameter | | Localization method | Same as Predicate. | Optical System (infrared Camera) | | Camera system | Same as Predicate. | Monocular | | Controller | Same as Predicate. | Manual macro adjustments Force-controlled movement of Targeting platform | | Patient Registration Method | Same as Predicate. | Registration fixture in place during 3D intraoperative images | | Accuracy verification on anatomical landmarks | Same as Predicate. | Yes | | Real time display of instrument position | Same as Predicate. | Yes | | Instrument Guidance | Same as Predicate. | Trajectory and location set by Targeting platform. Instruments are manually positioned by the surgeon through the guide tube on the Targeting Platform. | | Patient fixation | Same as Predicate. | Tracking Camera is fixed to OR table and the patient's iliac crest. | | Positioning accuracy (bench | Same as Predicate. | $0.74 \pm 0.36$ mm (worst case) 95% CI: 1.46mm (worst case) | | Robot collision avoidance/detection | Same as Predicate. | Manual movement of Trajectory Platform to gross location. Small fine tuning of Trajectory Platform location is automatic but is current limited to cease when platform encounters a force greater than 9lbs. | {5}------------------------------------------------ {6}------------------------------------------------ ### PSIS Pin Addition Two PSIS pins were added for this submission: 150mm x 6mm PSIS Pin (PN6025) and 100mm x 6mm (PN6026). The PSIS pins are made of titanium (Ti6Al4V ELI PER ASTM F136). This material is used by Integrity Implants (d/b/a Accelus) in their LineSider Spinal System pedicle screws cleared in K190360. The biocompatibility assessment for Ti6Al4V ELI is included in K190360. # Performance Testing - Bench The following tests were performed to support the substantial equivalence of the subject Remi Robotic Navigation System (Remi) to its predicates: - 3D Imager Accuracy Software Test Verification - Usability Validation Testing was done to demonstrate that the updated requirement for this change was met and to ensure the risk profile of Remi was maintained. The testing shows that the use of the GE OEC 3D C-arm (K203346), Stryker Airo (K160126) and Ziehm Vision 3D C-arm (K202360) with the Remi system is equivalent to the use of the Medtronic O-arm. The following factors were used to show equivalence. - Image Quality - Image Transfer Speed - Image Registration Speed - Registration Accuracy {7}------------------------------------------------ # Conclusions The subject device, Remi Robotic Navigation System, described in this submission has the same intended use and the same technological characteristics as the predicate device, Remi Robotic Navigation System (K202184). The primary difference between the subject device and the predicate is the addition of other validated 3D imaging systems and the subsequent modification of the indications for use. The verification and validation testing demonstrated that the characteristics of the subject Remi device are substantially equivalent to the predicate device. The subject device continues to meet design requirements, is as safe and effective as the predicate device, and performs according to its intended use. The information presented in this 510(k) premarket notification demonstrates that the subject device is substantially equivalent to the predicate Remi Robotic Navigation System (K202184).