# K031590: Sectra Orthopedic Package

- Pathway: 510(k) (Traditional)
- Applicant: Sectra-Imtec AB
- Decided: Oct 2, 2003 after 134 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: 1 generation back to K002936 (2000). 1 ancestor in all.
136 later devices descend from it; 5 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002936: Modification to IDS5 Image Display System, Sectra-Imtec AB (2000)

## Most influential descendants
- K042816: Traumacad 1.2 (2004), 129 descendants of its own
- K073714: Traumacad Version 2.0 (2008), 117 descendants of its own
- K111019: Surgimap (TM) Spine (2011), 51 descendants of its own
- K142923: TraumaCad Mobile Release 1.0 (2015), 28 descendants of its own
- K141669: Surgimap (2014), 27 descendants of its own

## Indications for use
The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Source page: https://510kreport.com/device/K031590
Methodology: https://510kreport.com/methodology