# K261861: SPINEsim v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Mdsim S.A.
- Decided: Sep 15, 2026 after 103 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 7.

## Indications for use
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).

Source page: https://510kreport.com/device/K261861
Methodology: https://510kreport.com/methodology