# K111019: Surgimap (TM) Spine

- Pathway: 510(k) (Traditional)
- Applicant: Nemaris, Inc.
- Decided: Sep 30, 2011 after 171 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: 8 generations back to K896095 (1990). 21 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 1.

## Most influential descendants
- K141669: Surgimap (2014), 27 descendants of its own
- K163221: Mazor X (2017), 19 descendants of its own
- K180307: Mazor X (2018), 17 descendants of its own
- K182077: Mazor X System (Mazor X Stealth Edition) (2018), 16 descendants of its own
- K200935: Mazor X (2020), 15 descendants of its own

## Indications for use
The Surgimap Spine software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements of the images, to plan surgical procedures (osteotomies), and includes toots for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K111019
Methodology: https://510kreport.com/methodology