(145 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not provide any descriptions of AI-related components in the device description or performance studies.
No
The device is a software for preoperative surgical planning, assisting surgeons in viewing, storing, measuring radiological images, and planning the placement of spinal fixation devices. It does not directly interact with or treat the patient, therefore, it is not a therapeutic device.
No.
The document states that the MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons, not to diagnose a condition. It helps with viewing, storing, measuring images, and planning implant placement.
Yes
The device explicitly states it is "The MySpine WebPlanner software" and "an interactive web application." Its function is described solely in terms of processing and displaying digital images and data for surgical planning, without any mention of accompanying hardware or physical components being part of the submitted device.
No.
The device is a surgical planning software that uses radiological images to assist surgeons in planning spinal fixation surgery. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
Product codes
LLZ
Device Description
The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/. The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images
Anatomical Site
spinal
Indicated Patient Age Range
skeletally mature and immature individuals
Intended User / Care Setting
competent person, authorized orthopedic or neurosurgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Software verification and validation was performed to address the introduction of the new module. Software verification and validation studies are provided in support of a substantial equivalence determination.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
FDA 510(k) Clearance Letter - MySpine WebPlanner
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Medacta International S.A.
℅ Christoper Lussier
Senior Director, Quality, Regulatory, and Clinical Research
Medacta USA
6386 Global Drive, Suite 101
Memphis, TN 38141
Re: K243697
Trade/Device Name: MySpine WebPlanner
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: November 29, 2024
Received: March 25, 2025
Dear Christoper Lussier:
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.
April 23, 2025
Page 2
Medacta International S.A.
℅ Christoper Lussier
Senior Director, Quality, Regulatory, and Clinical Research
Medacta USA
6386 Global Drive, Suite 101
Memphis, TN 38141
April 23, 2025
Re: K243697
Trade/Device Name: MySpine WebPlanner
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: November 29, 2024
Received: March 25, 2025
Dear Christoper Lussier:
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 and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 3
K243697 - Christoper Lussier 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 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
Page 4
K243697 - Christoper Lussier Page 3
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, PhD
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
Page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243697
Device Name
MySpine WebPlanner
Indications for Use (Describe)
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
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."
Page 6
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
Page 1 of 4
510(k) Summary
I. Submitter
Medacta International SA
Strada Regina
6874 Castel San Pietro (CH)
Switzerland
Phone (+41) 91 696 60 60
Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA
Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA
Date Prepared: November 29, 2024
Date Revised: April 22, 2025
II. Device
| Device Proprietary Name: | MySpine WebPlanner |
| Common or Usual Name: | Picture archiving and communications system (PACS) |
| Classification Name: | System, Image Processing, Radiological |
| Primary Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Device Classification: | II |
III. Predicate Device
MySpine WebPlanner & MyBalance, K211386, Medacta International SA
IV. Device Description
The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image
Page 7
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
510(k) Summary
I. Submitter
Medacta International SA
Strada Regina
6874 Castel San Pietro (CH)
Switzerland
Phone (+41) 91 696 60 60
Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA
Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA
Date Prepared: November 29, 2024
Date Revised: April 22, 2025
II. Device
| Device Proprietary Name: | MySpine WebPlanner |
| Common or Usual Name: | Picture archiving and communications system (PACS) |
| Classification Name: | System, Image Processing, Radiological |
| Primary Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Device Classification: | II |
III. Predicate Device
MySpine WebPlanner & MyBalance, K211386, Medacta International SA
IV. Device Description
The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image
Page 1 of 4
Page 8
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
Page 2 of 4
format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/.
The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).
V. Indications for Use
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
VI. Comparison of Technological Characteristics
| MySpine WebPlanner (Subject device) | MySpine WebPlanner [K211386] (Predicate device) | |
|---|---|---|
| Manufacturer | Medacta International SA | Medacta International SA |
| Indications for Use | The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. |
The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals.
The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning.
To properly use the MySpine WebPlanner, | The MySpine WebPlanner is a surgical pre-operative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of the spinal fixation devices.
The MyBalance, a module of the MySpine WebPlanner, allows to perform generic as well as specific measurements of patient's sagittal alignment and to plan spinal surgical procedures (osteotomies or Lordosis/ Kyphosis correction in spinal |
Page 9
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/.
The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).
V. Indications for Use
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
VI. Comparison of Technological Characteristics
| MySpine WebPlanner (Subject device) | MySpine WebPlanner [K211386] (Predicate device) | |
|---|---|---|
| Manufacturer | Medacta International SA | Medacta International SA |
| Indications for Use | The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. |
The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals.
The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning.
To properly use the MySpine WebPlanner, | The MySpine WebPlanner is a surgical pre-operative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of the spinal fixation devices.
The MyBalance, a module of the MySpine WebPlanner, allows to perform generic as well as specific measurements of patient's sagittal alignment and to plan spinal surgical procedures (osteotomies or Lordosis/ Kyphosis correction in spinal |
Page 2 of 4
Page 10
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
Page 3 of 4
| MySpine WebPlanner (Subject device) | MySpine WebPlanner [K211386] (Predicate device) | |
|---|---|---|
| clinical judgment, and experience are required. |
The MySpine WebPlanner software leads to the generation of a planning report. | fusion surgeries).
To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required. |
| Hardware | Laptop and/or PC and/or tablet | Identical |
| Operative system | Independent from the operative system since it is a web application | Identical |
| Image input | DICOM images | Identical |
| Design | Web application accessible through Chrome or Firefox browsers | Identical |
| Database | Images are stored on the Medacta server | Identical |
| User interface | GUI | Identical |
| Workflow | 1. Surgeon uploading of the patient's radiological images
2. Images quality control check
3. Segmentation of the 3D bone model
4. Surgery plan
5. Surgery plan validation by the surgeon
6. Report provision
7. Patient-matched guides | Identical |
| User interactions | Steps 2-3-4 as well as steps 6-7 of the workflow are performed by Medacta operators who have been specifically trained for this purpose.
The surgeon is required to upload the patients' images (Step 1 of the workflow) and to check and eventually modify the implant position and size on each vertebra (step 5 of the workflow) | Identical |
| Output Measurements | • Planning report showing the surgical parameters (including screws and cages planning)
• Patient-matched guides creation according to the planning (optional)
• MyBalance module only: Analysis of the spinopelvic anatomy (e.g. SS, PT, LL, PI-LL) including variations resulting from natural and modified lordosis | • Planning report showing the surgical parameters (including screws planning)
• Patient-matched guides creation according to the planning (optional)
• MyBalance module only: Analysis of the spinopelvic anatomy (e.g. SS, PT, LL, PI-LL) including variations resulting from natural and modified lordosis |
Page 11
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
| MySpine WebPlanner (Subject device) | MySpine WebPlanner [K211386] (Predicate device) | |
|---|---|---|
| clinical judgment, and experience are required. | fusion surgeries). | |
| To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required. | ||
| The MySpine WebPlanner software leads to the generation of a planning report. | ||
| Hardware | Laptop and/or PC and/or tablet | Identical |
| Operative system | Independent from the operative system since it is a web application | Identical |
| Image input | DICOM images | Identical |
| Design | Web application accessible through Chrome or Firefox browsers | Identical |
| Database | Images are stored on the Medacta server | Identical |
| User interface | GUI | Identical |
| Workflow | 1. Surgeon uploading of the patient's radiological images |
- Images quality control check
- Segmentation of the 3D bone model
- Surgery plan
- Surgery plan validation by the surgeon
- Report provision
- Patient-matched guides | Identical |
| User interactions | Steps 2-3-4 as well as steps 6-7 of the workflow are performed by Medacta operators who have been specifically trained for this purpose.
The surgeon is required to upload the patients' images (Step 1 of the workflow) and to check and eventually modify the implant position and size on each vertebra (step 5 of the workflow) | Identical |
| Output Measurements | • Planning report showing the surgical parameters (including screws and cages planning)
• Patient-matched guides creation according to the planning (optional)
• MyBalance module only: Analysis of the spinopelvic anatomy (e.g. SS, PT, LL, PI-LL) including variations resulting from natural and modified lordosis | • Planning report showing the surgical parameters (including screws planning)
• Patient-matched guides creation according to the planning (optional)
• MyBalance module only: Analysis of the spinopelvic anatomy (e.g. SS, PT, LL, PI-LL) including variations resulting from natural and modified lordosis |
Page 3 of 4
Page 12
MySpine WebPlanner
Traditional 510(k)
Medacta International SA
Page 4 of 4
| MySpine WebPlanner (Subject device) | MySpine WebPlanner [K211386] (Predicate device) | |
|---|---|---|
| Patient contact | None | Identical |
There are slight differences between the subject and predicate device indications for use statements; however, the differences do not alter the intended use of the subject device when compared to the predicate device. Both devices are software only devices intended for use in preoperative surgical planning in spine cases.
Apart from the addition of cage planning capability, the subject and predicate devices are identical.
The addition of cage planning to the MySpine WebPlanner interface does not introduce different questions of safety and effectiveness when compared to the predicate device. Software verification and validation was performed to address the introduction of the new module.
VII. Performance Data
Software verification and validation studies are provided in support of a substantial equivalence determination.
VIII. Conclusion
The information provided above supports that the MySpine WebPlanner is substantially equivalent to the predicate device.