Who is the manufacturer of Paradigm System?

Proprio, Inc. filed the 510(k) submission for Paradigm System (K243258).

What is the FDA product code for Paradigm 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 Paradigm System?

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

Who can help prepare an FDA 510(k) submission like Paradigm 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.

Paradigm System

K243258 · Proprio, Inc. · OLO · Feb 21, 2025 · Neurology

Device Facts

Record ID	K243258
Device Name	Paradigm System
Applicant	Proprio, Inc.
Product Code	OLO · Neurology
Decision Date	Feb 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

Device Story

Paradigm System is a stereotaxic image guidance system for spinal surgery. Inputs: preoperative CT patient images; real-time camera imaging of surgical site; surgical navigation data. Operation: system software generates 3D model of patient vertebrae from CT data; intraoperative registration matches live anatomy topography to 3D model via Prism Sensor Array; creates common coordinate space between preoperative data and live anatomy. Output: virtual information overlaid on live anatomy via external monitor. Used in OR by surgeons. Benefits: enables precise spatial positioning and orientation of spinal instruments; facilitates pedicle screw cannulation.

Clinical Evidence

No clinical data. Evidence consists of non-clinical hardware, software, and instrumentation verification tests, and non-clinical design validation conducted in a cadaveric model. Testing followed standards including ASTM F2554-22 for positional accuracy.

Technological Characteristics

Stereotaxic image guidance system. Components: cart, arm, sensor array, external monitor, surgical instruments, software. Energy: 120V. Sterilization: steam for instruments (SAL 1x10^-6); ethylene oxide for optional drape (SAL 1x10^-6). Connectivity: external monitor. Software lifecycle: IEC 62304 compliant.

Indications for Use

Indicated for posterior approach spine surgery in patients requiring pedicle screw cannulation of thoracic to sacrum vertebrae, where rigid anatomical structures are identifiable on CT images.

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

Paradigm System (K222291)

Reference Devices

Reflective Markers (Northern Digital K033621)

Related Devices

K222291 — Paradigm System · Proprio, Inc. · Apr 21, 2023
K252950 — Paradigm System · Proprio, Inc. · Dec 15, 2025
K250879 — Paradigm System · Proprio, Inc. · Jun 4, 2025
K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) · Alphatec Spine, Inc. · Feb 19, 2026
K242271 — Caduceus S · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Oct 30, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue. Below the FDA logo is the word "ADMINISTRATION". February 21, 2025 Proprio, Inc. Shannon Eubanks Vice President, Hardware Engineering and Regulatory 111 W. John St., Suite 308 Seattle, Washington 98119 Re: K243258 Trade/Device Name: Paradigm System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2025 Received: January 23, 2025 #### Dear Shannon Eubanks: 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" (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). {1}------------------------------------------------ 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 {2}------------------------------------------------ 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 Enclosure {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K243258 Device Name Paradigm System Indications for Use (Describe) The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. 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." {4}------------------------------------------------ ## Traditional 510(k) Summary | Submitter: | Proprio, Inc. | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Shannon Eubanks | | | VP of HW Engineering and Regulatory | | | Phone: (425) 802-6063 | | | Email: seubanks@propriovision.com | | Trade Name: | Paradigm System | | Common Name: | Orthopedic stereotaxic instrument | | Classification: | Class II | | Product Code: | OLO | | Regulation: | 21 CFR 882.4560 | | Predicate Device(s): | The subject device is equivalent to the following device: Paradigm System (K222291) | | Device Description: | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high- resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. | | | The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. | | | The Paradigm System is used with an external monitor. | | Indications For Use: | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. | {5}------------------------------------------------ | | Paradigm System (Subject Device) | Paradigm System (Predicate Device) | Comment | | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Device Overview | | | | | | | | 510(k) Number | K243258 | K222291 | | | | | | Decision Date | | April 21, 2023 | | | | | | Manufacturer | Proprio, Inc. | Proprio, Inc. | | | | | | Classification | Class II | Class II | Same | | | | | Product Code | OLO | OLO | Same | | | | | Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | Same | | | | | Medical Specialty | Neurology | Neurology | Same | | | | | Indications For Use | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. | The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae. | Same | | | | | | Principle of operation | Paradigm System fuses high- resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. | | Paradigm System fuses high- resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. | | | | | | The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the | | The Paradigm System enables surgical navigation of instruments relative to the patient spinal anatomy by combining preoperative imaging segmentation and intraoperative registration of the patient's live anatomy. Preoperative CT data is uploaded to the console and the system software generates a 3D model of the patient's operative vertebrae. The 3D model is used for preoperative planning such as implant placements or instrument trajectories. During the procedure, once the patient's anatomy is exposed, the Prism Sensor Array acquires imaging to match the topography of the live anatomy to the 3D model. This intraoperative registration of live anatomy to the 3D model creates a common coordinate space between the | Same | | | | | | | Paradigm System (Subject Device) | Paradigm System (Predicate Device) | Comment | | | | | | preoperative CT data and the patient anatomy. This enables virtual information to be overlaid on the live anatomy during the procedure for intraoperative guidance. | preoperative CT data and the patient anatomy. This enables virtual information to be overlaid on the live anatomy during the procedure for intraoperative guidance. | | | | | Technical Comparison | | Stereotaxic image guided surgical navigation system during spine surgery. Preoperative CT data is segmented and a 3D model is generated. Preoperative planning can be performed. Intraoperative image capture using reflective markers on spinal instruments and registers the patient's anatomy to the preoperative 3D model for intraoperative guidance during the procedure. | Stereotaxic image guided surgical navigation system during spine surgery. Preoperative CT data is segmented and a 3D model is generated. Preoperative planning can be performed. Intraoperative image capture using reflective markers on spinal instruments and registers the patient's anatomy to the preoperative 3D model for intraoperative guidance during the procedure. | Same | | | | Components | | Cart, Arm, Sensor Array, External Monitor, Surgical Instruments, Software | Cart, Arm, Sensor Array, External Monitor, Surgical Instruments, Software | Same | | | | Energy Source | | 120V | 120V | Same | | Sterilization Method - Surgical Instruments | | Steam | Steam | Same | | | | Minimum SAL | 1 x 10-6 | 1 x 10-6 | Same | | | | | Required Accessories | Reflective Markers (Northern Digital K033621) | Reflective Markers (Northern Digital K033621) | Same | | | | | Optional Accessories | Paradigm Drape | Any drape | New accessory, not required for Paradigm System performance | | | | | Sterilization Method – drape | Ethylene Oxide | Not applicable | Required sterilization for optional drape accessory | | | | | Minimum SAL | 1 x 10-6 | Not applicable | Required to claim sterile, single-use for drape | | | | {6}------------------------------------------------ {7}------------------------------------------------ | Functional and Safety Testing: | Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions. Proprio performed the following testing to ensure the safety and effectiveness of the Paradigm System device: •Non-Clinical Hardware, Software, and Instrumentation Verification Tests •Non-Clinical Design Validation conducted in Cadaveric Model •Compliance Conformity Assessments The following standards were used in testing: | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------…