# K142648: SPINEDESIGN Spine Surgery Planning (Software Application)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 22, 2015 after 247 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.
No later device cites it as a predicate yet.
0 of 23 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.

## Indications for use
The SPINEDESIGN™ Spine Surgery Planning application is a mobile medical application to assist healthcare professionals in planning orthopedic surgeries. The device allows service providers to perform spine related measurements of the images in the preoperative planning of orthopedic spinal surgery and includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. This software is for orthopedic planning only; not for primary image viewing.

Source page: https://510kreport.com/device/K142648
Methodology: https://510kreport.com/methodology