Who is the manufacturer of TraumaCad Neo?

Brainlab , Ltd. filed the 510(k) submission for TraumaCad Neo (K231498).

What is the FDA product code for TraumaCad Neo?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for TraumaCad Neo?

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

Who can help prepare an FDA 510(k) submission like TraumaCad Neo?

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.

TraumaCad Neo

Q: What are the predicate devices for TraumaCad Neo?

TraumaCad Mobile 2.0 (K160001).

K231498 · Brainlab , Ltd. · LLZ · Nov 20, 2023 · Radiology

Device Facts

Record ID	K231498
Device Name	TraumaCad Neo
Applicant	Brainlab , Ltd.
Product Code	LLZ · Radiology
Decision Date	Nov 20, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

Device Story

TraumaCad Neo is a software application for orthopedic surgical planning and post-operative image review. It receives digital radiological images via the Quentry® cloud service. Surgeons use the software on PCs, Macs, iPads, or Android tablets to perform measurements, position digital prosthesis templates from a library, and plan procedures. The device supports hip, knee, foot/ankle, and upper limb modules. It allows simultaneous viewing of up to three images. The software facilitates a film-less workflow by enabling pre-operative planning and post-operative review. It does not perform primary image interpretation; clinical judgment is required. The output assists surgeons in visualizing surgical outcomes, potentially improving procedural accuracy and planning efficiency.

Clinical Evidence

Bench testing only. Performance evaluation was based on established test methods used for the predicate device to demonstrate conformity to intended use and substantial equivalence.

Technological Characteristics

Radiological image processing system; software-based. Supports DICOM. Cloud-integrated via Quentry®. Operates on Windows 10+, iOS 16+, macOS 11+, and Android 11+. Supports PC, Mac, iPad, and Android tablets. Features include automatic scaling, interactive template positioning, and template rotation. No patient contact. Non-life sustaining.

Indications for Use

Indicated for healthcare professionals to analyze orthopedic conditions and plan orthopedic procedures via overlaying measurements and prosthesis templates on radiological images. Not for primary radiological image interpretation or appraisal. Not for use on mobile phones.

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

TraumaCad Mobile 2.0 (K160001)

Related Devices

K243810 — TraumaCad Neo (1.1) · Brainlab , Ltd. · Jun 4, 2025
K073714 — TRAUMACAD VERSION 2.0 · Orthocrat, Ltd. · Mar 19, 2008
K042816 — TRAUMACAD 1.2 · Orthocrat, Ltd. · Nov 10, 2004
K142923 — TraumaCad Mobile Release 1.0 · Voyant Health, Ltd. · Mar 5, 2015
K160001 — TraumaCad Mobile Release 2.0 · Voyant Health, Ltd. · Feb 12, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Brainlab Ltd. % Yael Guttentag QM & RA Senior Manager 35 Efal Street Petach-Tikva, 4951132 Israel Re: K231498 November 20, 2023 Trade/Device Name: TraumaCad Neo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2023 Received: October 18, 2023 Dear Yael Guttentag: 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K231498 Device Name TraumaCad Neo Indications for Use (Describe) TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones. | 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}------------------------------------------------ ## Æ BRAINLAB 510(k) Summary # K231498 Pursuant to CFR 807.92, the following 510(k) Summary is provided: | 1. (a) | Submitter Address: | Brainlab Ltd 35 Efal Street Petach-Tikva, Israel 4951132 | |--------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. (b) | Manufacturer Address: | Brainlab Ltd 35 Efal Street Petach-Tikva, Israel 4951132 | | | Mfg. Phone: | Tel.: +972-3-929-0929 | | | Contact Person: | Mrs. Yael Guttentag | | | Date: | May 22, 2023 | | 2. | Device & Classification Name: | Radiological Image Processing System - classified as Class 2 LLZ, Regulation Number 21 CFR 892.2050 TraumaCad Neo | | 3. | Predicate Device: | TraumaCad Mobile 2.0 (K160001) | | 4. | Description: | TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish. | | 5. | Indications for Use: | TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software. The software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones. | {4}------------------------------------------------ - 6. Comparison of With respect to technology and intended use, TraumaCad Neo is Technological substantially equivalent to its predicate device. Based upon the outcomes Characteristics: from the Risk Analysis and Performance Testing Evaluation, Brainlab Ltd believes that the modification of TraumaCad Mobile 2.0 (predicate device) which allows it to become TraumaCad Neo does not raise additional safety or efficacy concerns. The following comparison table depicts the changes. | | Submitted Device | Predicate Device | |-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Features/ Characteristics | TraumaCad Neo | TraumaCad Mobile Release 2.0 | | Product Code | LLZ | LLZ | | Indication for Use | TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software. The software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones. | The TraumaCad Mobile Release 2.0 program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones. | | Operating System | Microsoft Windows 10 and above iOS 16.x and above MAC OS 11 and above Android 11 and above | MS Windows 7, 8 or 10 iOS 7.x, 8.x or 9.x MAC OS X | | Devices Supported | PC MAC iPads Android tablets | PC/MAC iPad 3, 4 and 5 (Air) | | Browsers Supported | Microsoft Edge Firefox Chrome Safari (MAC/iOS) | Minimum requirements: iOS based browsers: - Safari 7 - Chrome 30 Mac based browsers: - Firefox 26 - Safari 5 Windows based browsers: - Chrome 30 - Firefox 26 - Safari 5 - IE 11 | | Image Input | Can receive digital images from Quentry® | Can receive digital images from various sources | | Means of Collecting Data | Obtained from pre-obtained digital images via Quentry® | Obtained from pre- obtained digital images via PACS or via Quentry® | | Number of Images that can simultaneously viewed on the screen | Up to 3 | Up to 2 | | Runs on Server | yes | yes | | Hip Module | yes | yes | | Knee Module | yes | yes | | Foot and Ankle Module | yes | yes | | Upper Limb Module | yes | yes | | Digital Prosthetic Templates | yes | yes | | Interactive template positioning | yes | yes | | Automatic Scaling | yes | yes | | Template support from manufacturers | yes | yes | | Permits Template Rotation | yes | yes | | Pre-Operative Planning | yes | yes | | Post Operative Review | yes | no | | Patient Contacting | no | no | | Control of Life Sustaining Devices | no | no | | Healthcare professional intervention for interpretation of images | yes | yes | | 510(k) # | Pending | K160001 | {5}------------------------------------------------ 510k Notification: TraumaCad Neo {6}------------------------------------------------ - The Performance Evaluation of TraumaCad Neo was based upon well-7. Performance Evaluation: established test methods which demonstrated conformity to the intended use. These test methods were the same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0. - 8. Conclusion: The intended use and the fundamental technological characteristics of TraumaCad Neo are the same as those in the TraumaCad Mobile 2.0, which is the predicate device. Any additions or differences do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully confirm the performance of the device. Based upon this data, Brainlab Ltd believes that TraumaCad Neo is substantially equivalent to the predicate device.