UNiD™ Spine Analyzer (SW3002)
Device Facts
| Record ID | K261289 |
|---|---|
| Device Name | UNiD™ Spine Analyzer (SW3002) |
| Applicant | Medicrea International S.A.S. (Medtronic) |
| Product Code | QIH · Radiology |
| Decision Date | May 15, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
Indications for Use
The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Device Story
Web-based application for preoperative/postoperative spine surgery planning; inputs radiological images (JPEG, PNG, GIF). Performs generic and spine-specific measurements (e.g., lordosis, kyphosis, SVA, Lenke classification); simulates surgical strategies (wedge, open, resect); estimates compensatory effects; designs patient-specific rods or selects standard implants. Used by surgeons and service providers in clinical settings. Medtronic performs planning services; surgeons validate plans before implant manufacturing. Cloud-hosted (AWS) via standalone or connected mode (Gaiteway™). Output includes annotated images, geometric parameters, and measurement reports. Assists in surgical precision and implant placement.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical performance data including risk management (ISO 14971), usability assessment (IEC 62366-1), software verification (IEC 62304), software validation (IEC 82304-1), and statistical assessment of the Degenerative Predictive Model (DPM) v2.0.
Technological Characteristics
Standalone web-based software; cloud-hosted (AWS). PC-compatible (Windows/Mac). Frontend: Angular 14/Angular JS 1.7; Backend: .NET 8.0; Database: SQL Server. Connectivity: Standalone or connected via Gaiteway™. Sterilization: N/A. Software lifecycle: IEC 62304 compliant.
Indications for Use
Indicated for children (2-12 years), adolescents (12-22 years), and adults (22+ years) requiring orthopedic surgical planning and image measurement.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- UNiD™ Spine Analyzer 5.0.0 (K251629)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
Medicrea International S.A.S. (Medtronic)
Hajar BOULMAN
Sr Regulatory Affairs Specialist
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape, 69140
France
May 15, 2026
Re: K261289
Trade/Device Name: UNiD™ Spine Analyzer (SW3002)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical image management and processing system
Regulatory Class: Class II
Product Code: QIH, LLZ
Dated: April 17, 2026
Received: April 20, 2026
Dear Hajar BOULMAN:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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).
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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Jessica Lamb, Ph.D.
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261289 | ? |
| Please provide the device trade name(s). | | ? |
| UNiD™ Spine Analyzer (SW3002) | | |
| Please provide your Indications for Use below. | | ? |
| The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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MEDICREA
MEDICREA INTERNATIONAL (MEDTRONIC)
Special 510(k) Application – UNID Spine Analyzer
Page 1 of 5
# 510(k) Summary
As required by 21 CFR 807.87(h)
The 510(k) Summary is presented on the next page.
The remainder of this page is intentionally left blank
510(k) Summary
MEDICREA INTERNATIONAL S.A.S (MEDTRONIC), 5389 route de Strasbourg - Vancia - 69140 Rillieux-la-Pape • France
Tel +33(0)4 72 01 87 87 Fax +33 (0)4 72 01 87 88
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510(k) Summary
UNiD™ Spine Analyzer
Date prepared: April 17, 2026
| I. Submitter information | | |
| --- | --- | --- |
| Submitter | MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC) 5389 Route de Strasbourg – Vancia Rillieux-la-Pape, 69140 France Phone : 00 33 4 72 01 87 87 | |
| Contact Person | Hajar BOULMAN Sr Regulatory Affairs Specialist MEDTRONIC | |
| II. Device identification | | |
| Trade name | UNiD™ Spine Analyzer | |
| Classification Regulation | Common Name | Automated radiological image processing software |
| | Primary Product Code | QIH |
| | Associated Product Code | LLZ |
| | Regulation Number | 21 CFR 892.2050 |
| | Regulation Name | Medical Image Management and Processing System |
| | Class | 2 |
| III. Predicate and reference devices | | |
| Primary predicate device | Device name | UNiD™ Spine Analyzer 5.0.0 |
| | 510(k) information | K251629, cleared on 08/07/2025 |
| | Common Name | Automated radiological image processing software |
| | Primary Product Code | QIH |
| | Product Code | LLZ |
| | Regulation Number | 21 CFR 892.2050 |
| | Regulation Name | Medical image management and processing system |
| | Class | 2 |
| IV. Subject device description | | |
| The device description is identical to the predicate device. The UNiD™ Spine Analyzer is a web-based application developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. It aims to make measurements on a patient image, simulate a surgical strategy, draw patient-specific rods or choose from a pre-selection of standard implants. The UNiD™ Spine Analyzer allows the user to: 1. Measure radiological images using generic tools and “specialty” tools 2. Plan and simulate aspects of surgical procedures 3. Estimate the compensatory effects of the simulated surgical procedure on the patient’s spine The planning of surgical procedures is done by Medtronic as part of the service of pre-operative planning. The surgical plan may then be used to assist in designing patient-specific implants. Surgeons will have to validate the surgical plan before Medtronic manufactures any implant. | | |
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The UNiD™ Spine Analyzer interface is accessible in either standalone mode or connected mode.
| V. Intended use and indications for use | | |
| --- | --- | --- |
| Intended use / Indications for use | The intended use/indications for use are identical to the predicate device. The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. | |
| VI. Comparison of technological characteristics | | |
| The subject device has similar fundamental scientific technology, overall design, features, computer configuration characteristics, intended use, and indications as the predicate device. The subject device and the predicate device are intended to assist healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The main software modifications incorporated into UNiD™ Spine Analyzer 5.1.0, as compared with the predicate device, are summarized below: • update the communication of the UNiD Spine Analyzer from UNiD™ HUB to Gaiteway™; • unblocking of Degenerative Predictive Model in cases where femoral heads are not visible on the image, using an indirect method based on a secondary image; • transfer and correction of the L1-L4 and L4-S1 calculation from Lambda application to the UNiD™ Spine Analyzer system; • update of the Predict Tool to prevent selection of a UIV/LIV outside the model’s specification; • bug fixes in measurement tools and related workflows; and • cybersecurity fixes. | | |
| The subject device and the predicate device are compared in the table below. | | |
| Feature/ Attribute | Subject Device UNiD™ Spine Analyzer 5.1.0 | Predicate UNiD™ Spine Analyzer 5.0.0 (K251629) |
| Product code(s) | QIH, LLZ | QIH, LLZ |
| Regulation number | 892.2050 | 892.2050 |
| Classification | 2 | 2 |
| Intended use / Indications for use | The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. | The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. |
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| Fundamental scientific technology | Standalone software | Standalone software |
| --- | --- | --- |
| Computer | PC Compatible | PC Compatible |
| Operating System | Windows + Mac | Windows + Mac |
| Supply mean | Cloud-based | Cloud-based |
| Health Data Host | AWS | AWS |
| Frontend code | Angular 14 & Angular JS 1.7 | Angular 14 & Angular JS 1.7 |
| Backend code | .NET 8.0 | .NET 8.0 |
| Databases server | SQL Server | SQL Server |
| Human intervention | Required for interpretation and manipulation of images | Required for interpretation and manipulation of images |
| Supported image format | JPEG; PNG; GIF | JPEG; PNG; GIF |
| Access mode | Standalone or connected mode (via Gaiteway software) | Standalone or connected mode (via UNiD™ HUB software) |
| Feature - Image setting | Contrast; brightness; zoom in/out; flip, rotate, text overlay, calibration | Contrast; brightness; zoom in/out; flip, rotate, text overlay, calibration |
| Feature - Generic measurements tools | Line; circle; angle; measured, simulated, and normative values display; values color-coding | Line; circle; angle; measured, simulated, and normative values display; values color-coding |
| Feature - Spine measurements tools | Llordo; TKypho; pelvic; T1SPi; SVA; SA Analysis; Sagittal wizard; Coronal wizard; Transitional anatomy (as part of SA Analysis or Sagittal wizard); Cervical; Lenke classification; Coronal correction factor | Llordo; TKypho; pelvic; T1SPi; SVA; SA Analysis; Sagittal wizard; Coronal wizard; Transitional anatomy (as part of Sagittal wizard); Cervical; Lenke classification; Coronal correction factor |
| Feature - Surgical tools | Wedge; open; resect; wedge auto; open auto; resect auto; spondy | Wedge; open; resect; wedge auto; open auto; resect auto; spondy |
| Feature - Implants tools | Free Rod; cage; screw; screw selection; Rod Auto; cage auto; screw wizard; postop screw | Free Rod; cage; screw; screw selection; Rod Auto; cage auto; screw wizard; postop screw |
| Feature - Implants database | Adaptix PLIF, Capstone Control PLIF, Capstone PLIF, Clydesdale, Crescent, Divergence, IB3D PL, Pivox, Sovereign | Adaptix PLIF, Capstone Control PLIF, Capstone PLIF, Clydesdale, Crescent, Divergence, IB3D PL, Pivox, Sovereign |
| Feature - AI algorithms | Degenerative; Adult Deformity; Pediatric Deformity | Degenerative; Adult Deformity; Pediatric Deformity |
| Features - UNiD™ plan export | • As an image (.jpeg) • As a ZIP file comprising: - The initial image w/ and w/o measures (.jpeg) - The plan simulated image (.jpeg) - The rod geometric parameters (.txt) - All the drawn tools geometric parameters (.txt) - The measures (.csv) • To Gaiteway™ to request plan validation | • As an image (.jpeg) • As a ZIP file comprising: - The initial image w/ and w/o measures (.jpeg) - The plan simulated image (.jpeg) - The rod geometric parameters (.txt) - All the drawn tools geometric parameters (.txt) - The measures (.csv) • To Medtronic HUB to request plan validation |
Table 1: Substantial Equivalence Comparison
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| VII. Performance data | |
| --- | --- |
| Nonclinical tests | The following non-clinical performance data were provided in support of substantial equivalence: **Risk Management:** Assessment performed according to ISO 14971 and Medtronic procedures. All hazards and failures for the subject device have the same severity and occurrence as the predicate. No new or unresolved unknown hazards, hazardous situations and harm were identified. **Usability Assessment** Usability of the UNiD™ Spine Analyzer user interface was evaluated according to IEC 62366-1. The purpose was to assess new changes and ensure no usability issues could raise significant risks in terms of safety and effectiveness. **Software verification** The software verification is a combination of software code inspection, code review, software unit test, integration testing, non-regression testing and cybersecurity verification to ensure the software is developed correctly and adheres to its design specifications. Software verification was conducted on the UNiD™ Spine Analyzer in accordance with IEC 62304. **Software validation** The software validation was performed through user acceptance testing to ensure the software satisfies the specified requirements and meets the user’s needs. It was conducted on the UNiD™ Spine Analyzer in accordance with IEC 82304-1. **Statistical Assessment part of Design Validation activity** The assessment supports that the input data (femoral head centers or bifemoral mid-point) obtained through the indirect method do not compromise the validity of the Degenerative Predictive Model (DPM) v2.0 outputs. Comparative analysis demonstrated no significant difference in predictive outputs. |
| Clinical tests | No clinical testing was used to support this submission. |
| VIII. Conclusion | |
| Based on the information contained in this submission, the subject UNiD™ Spine Analyzer v5.1.0 device is substantially equivalent to the following predicate device: UNiD™ Spine Analyzer v5.0.0 (K251629, S.E. 08/07/2025) | |
