510(k) · Cleared
ClearedSPINEsim v1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mdsim S.A. · LLZ System, Image Processing, Radiological
Cleared on Sep 15, 2026 as substantially equivalent to K141669 (Nemaris, Inc., 2014) after a 103-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Sep 15, 2026
- Review
- 103 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK141669 SurgimapNemaris, Inc. · 2014
- This deviceK261861 SPINEsim v1.0Mdsim S.A. · 2026
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 4 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 3 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 2 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 1 generation backK141669 SurgimapNemaris, Inc. · 2014
- This deviceK261861 SPINEsim v1.0Mdsim S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −2 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −1 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| 0 (this device) | K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141669 | SurgimapSummary page 7…Summary III. PREDICATE DEVICE Predicate device: Surgimap 2.0 510(k) Number: K141669 Classification Name: System, image processing, radiological Product Code:… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 10 other devices also cite its predicate K141669.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
SPINEsim v1.0 is intended for assisting spine surgeons: • Visualizing and analyzing medical images. • Building a digital twin of the spine. • Computing spine parameters. • Using the digital twin and corresponding parameters to support clinical decision making. • Use the digital twin to plan spine surgery. • Comparing the simulated changes in parameters before and after various treatment options and between different treatment options. The device includes…
Read the full statement (315 words)
SPINEsim v1.0 is intended for assisting spine surgeons:
• Visualizing and analyzing medical images.
• Building a digital twin of the spine.
• Computing spine parameters.
• Using the digital twin and corresponding parameters to support clinical decision making.
• Use the digital twin to plan spine surgery.
• Comparing the simulated changes in parameters before and after various treatment options and between different treatment options.
The device includes the semi-automatic analysis, landmarking and labelling of spine’s anatomical bodies as seen in medical images, and the computation of parameters which include spino-pelvic parameters. Semi-automatic refers to the requested validation of the accuracy of the landmarking generated by our code by the user (spine surgeon).
Clinical judgment and experience are required to properly use the software.
SPINEsim v1.0 is indicated when the patient has one of the following conditions (ICD-11 classification - ICD-11 for Mortality and Morbidity Statistics (who.int)):
• Spinal deformities (FA70)
o Kyphosis (FA70.0)
o Scoliosis (FA70.1)
o Lordosis (FA70.2)
• Intervertebral disc degeneration (FA80)
• Spondylolysis (FA81)
• Spinal stenosis (FA82)
• Spondylolisthesis (FA84)
• Ankylosis of spinal joint (FB00)
• Sacralisation of the last lumbar vertebra (LB73.26)
• Lumbarisation of the first sacral vertebra (LB73.27)
and that the patient condition can be improved by conservative treatment and/or a spine surgery aiming at correcting the spine alignment.
Contraindications
• Patient not accepting the application of SPINEsim v1.0 for planning his/her surgery.
• Usage by non-trained clinicians.
• Incomplete and/or non-consistent medical data used as input.
• Medical images with inadequate formats, characteristics (e.g., field of views, pixel size, …) or artefacts.
• Patient with contraindications for fusion surgery.
SPINEsim v1.0 is applicable to the medical images of all patients independently of their gender, weight, height, BMI, ethnicity, skin type, nationality, habits (e.g. smoking).
The age group for which SPINEsim v1.0 is to be used is limited to adults (22 years old and greater).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261861: SPINEsim v1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261861
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026