SkeletonPlanner

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION July 15, 2026 UPlanner B.V. | Presurgeo % Carrie Britton Founder and CEO Britton Medical Consultancy, LLC 19123 W. 60th Lane Golden, Colorado 80403 Re: K260206 Trade/Device Name: SkeletonPlanner Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: June 12, 2026 Received: June 15, 2026 Dear Carrie Britton: 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 {1} K260206 - Carrie Britton Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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 {2} K260206 - Carrie Britton Page 3 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-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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K260206 Device Name SkeletonPlanner Indications for Use (Describe) SkeletonPlanner is intended to assist radiologists and orthopedic surgeons in the analysis of lower extremity alignment and/or preoperative planning of skeletal surgery procedures. It supports assessment of bone deformities in the femur and tibia and plan corrections for deformities amenable to single femoral or tibial osteotomies for skeletally mature patients 18 years of age and older. 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) Summary # SkeletonPlanner # K260206 # 1. Submission Sponsor Uplanner B.V. | PRESURGEO Nigtevechtseweg 94 3633 XW VREELAND The Netherlands Contact: Jessica Adams Title: CEO # 2. Submission Correspondent Britton Medical Consultancy LLC 19123 60th Lane Golden, CO 80403 Office Phone: (720) 838-4113 Contact: Carrie Britton Title: Founder and CEO Date Prepared July 14th, 2026 # 3. Device Identification (per 21 CFR 807.92(a)(2)) | Proprietary Name | SkeletonPlanner | | --- | --- | | Common / Usual Name | Orthopedic surgical planning software | | Classification Name | Orthopedic stereotaxic planning software | | Regulation Number | 21 CFR 892.2050 | | Regulation Name | Medical image management and processing system | | Product Code | QIH | | Device Class | II | | Classification Panel | Radiology | # 4. Legally Marketed Predicate Device(s) (per 21 CFR 807.92(a)(3)) Page 1 of 5 {5} The subject device SkeletonPlanner claims substantial equivalence to the following legally marketed predicate device: | **Trade Name** | SurgiCase Viewer | | --- | --- | | **Manufacturer** | Materialise NV | | **510(k) Number** | K213684 | | **Regulation Number** | 21 CFR 892.2050 | | **Regulation Name** | Medical image management and processing system | | **Product Code** | LLZ | | **Device Class** | II | The predicate device has not been withdrawn, removed, or found adulterated or misbranded by FDA. 5. **Indication for Use Statement** (*per 21 CFR 807.92(a)(5)*) SkeletonPlanner is intended to assist radiologists and orthopedic surgeons in the analysis of lower extremity alignment and/or preoperative planning of skeletal surgery procedures. It supports assessment of bone deformities in the femur and tibia and plan corrections for deformities amenable to single femoral or tibial osteotomies for skeletally mature patients 18 years of age and older. 6. **Device Description** (*per 21 CFR 807.92(a)(4)*) SkeletonPlanner is a semi-automated, cloud-based Software as a Medical Device (SaMD) accessed through standard web browsers. The system accepts CT DICOM data of the lower limbs, reconstructs 3D bone models using a deep learning segmentation component (nnU-Net), identifies anatomical landmarks, calculates alignment angles, and generates semi-automated osteotomy planning recommendations. All outputs require review and confirmation by a qualified clinician. Outputs include 3D visualizations, tabular measurements, customizable osteotomy plans, printable reports, and case notes. The user interface consists of a web-based GUI with tabbed navigation and an interactive 3D viewer. The device is intended for use by licensed radiologists and orthopedic surgeons in hospital or clinical environments. No proprietary hardware, implants, drugs, or patient-contacting materials are included. 7. **Substantial Equivalence** (*per 21 CFR 807.92(a)(6)*) A comparison of technological characteristics between SkeletonPlanner and the predicate SurgiCase Viewer (K213684) is provided below. Key points: - Both devices are regulated under **21 CFR 892.2050**, Class II. - Both are **SaMD** intended for orthopedic visualization and preoperative planning. - Both share the same intended users and patient population. Page 2 of 5 {6} - Differences in deployment (cloud-based vs. desktop), automation level, and product code (QIH vs. LLZ) do not alter the intended use and do not raise new questions of safety or effectiveness. **Table 1. Substantial Equivalence Table** | Feature / Characteristic | SkeletonPlanner (Presurgeo) | Predicate – SurgiCase Viewer (K213684) | Comparison / Notes | | --- | --- | --- | --- | | **Regulation Number** | 21 CFR 892.2050 | 21 CFR 892.2050 | **Same** | | **Regulatory Class** | II | II | **Same** | | **Product Code** | QIH | LLZ | Different codes; both under 21 CFR 892.2050 — reflects FDA classification refinement; does not alter intended use | | **Device Type** | SaMD | SaMD | **Same** | | **Platform** | Cloud-based, web browser | Desktop software | Different deployment; both operate on standard computing hardware; does not raise new safety/effectiveness questions | | **Input Data** | CT DICOM data of lower limbs | Patient imaging data (CT, MRI, etc.) | Both accept DICOM imaging data | | **Output Data** | 3D bone models, alignment angles, semi-automated osteotomy plan, printable reports | Visualization of anatomy and planning tools | Equivalent in purpose; SkeletonPlanner adds automation and structured reporting | | **Principle of Operation** | Semi-automated algorithms reconstruct 3D models, identify landmarks, calculate angles, propose osteotomy plan; surgeon customizes and confirms plan | User interacts with software to visualize and plan procedures | Same principle: software-based visualization and surgical planning | | **Deep Learning Component** | nnU-Net for automated femur/tibia segmentation; clinician review required prior to use | Not specified | Enhancement to workflow efficiency; clinician confirmation required; does not alter intended use | | **User Interface** | GUI with tabbed navigation; interactive 3D viewer | GUI with visualization and planning tools | Both provide GUI interfaces | | **Intended** | Radiologists and | Radiologists and | **Same** | Page 3 of 5 {7} | Feature / Characteristic | SkeletonPlanner (Presurgeo) | Predicate – SurgiCase Viewer (K213684) | Comparison / Notes | | --- | --- | --- | --- | | Users | orthopedic surgeons | orthopedic surgeons | | | Patient Population | Skeletally mature patients ≥18 years | Patients requiring orthopedic surgical planning | Same population; SkeletonPlanner explicitly scoped to adults ≥18 years | | Energy Source | Standard computing resources | Standard computing resources | Same | | Materials | Software only | Software only | Same | | Risk Controls | Software V&V, usability testing, cybersecurity risk analysis, risk management (ISO 14971), labeling, training | Software V&V, labeling | SkeletonPlanner adds cybersecurity and usability safeguards | | Regulatory Compliance | FDA QSR, ISO 13485 (BSI Certificate MD 548540) | FDA QSR, ISO 13485 | Same | ### 8. Summary of Nonclinical Performance Testing (per 21 CFR 807.92(b)(1)) Nonclinical performance testing was conducted to verify and validate SkeletonPlanner against design specifications and applicable consensus standards. Testing included: - Software Verification & Validation (IEC 62304) - Segmentation Accuracy: - Observed: DSC > 0.97 - Acceptance Criterion: DSC ≥ 0.95 - Landmark Identification Accuracy: - Observed: mean error < 2.0 mm - Acceptance Criterion: ≤ 3.0 mm - Angle Measurement Accuracy: - Observed: mean absolute error < 1.5° - Acceptance Criterion: ≤ 3.0° - Cybersecurity Testing (CVSS v4.0; penetration testing, fuzzing, vulnerability scanning) - Human Factors / Usability Validation (IEC 62366; representative users; all critical tasks completed safely) - Risk Management (ISO 14971) All testing met acceptance criteria. ### 9. Summary of Clinical Performance Testing (per 21 CFR 807.92(b)(2)) No clinical performance testing was conducted. No clinical performance testing was conducted. Usability Page 4 of 5 {8} validation was performed under simulated-use conditions with representative users. These studies constitute nonclinical performance testing and do not meet the definition of a clinical investigation under 21 CFR 812.28. ### 10. Statement of Substantial Equivalence SkeletonPlanner (Presurgeo, Uplanner B.V.) is substantially equivalent to the predicate SurgiCase Viewer (K213684). Both devices share the same intended use, regulatory classification, device type, and fundamental operating principles. Differences in automation, deployment architecture, and product code do not raise new questions of safety or effectiveness. Nonclinical performance testing supports the safety and effectiveness of the subject device for its intended use. This 510(k) Summary has been prepared in accordance with 21 CFR 807.92. Page 5 of 5