# K211386: MySpine WebPlanner & MyBalance

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 23, 2021 after 79 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: 9 generations back to K896095 (1990). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111019: Surgimap (TM) Spine, Nemaris, Inc. (2011) Summary page 4.

## Most influential descendants
- K243697: MySpine WebPlanner (2025), 0 descendants of its own

## Indications for use
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 fusion surgeries). To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required.

Source page: https://510kreport.com/device/K211386
Methodology: https://510kreport.com/methodology