# K042816: Traumacad 1.2

- Pathway: 510(k) (Traditional)
- Applicant: Orthocrat, Ltd.
- Decided: Nov 10, 2004 after 29 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: 6 generations back to K896095 (1990). 9 ancestors in all.
129 later devices descend from it; 5 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032401: Orthoview, Omsbar, Ltd. (2003) Summary page 2.
- K031590: Sectra Orthopedic Package, Sectra-Imtec AB (2003) Summary page 2.

## Most influential descendants
- 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
- K160284: JointPoint (2016), 21 descendants of its own

## Indications for use
The TraumaCAD program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

Source page: https://510kreport.com/device/K042816
Methodology: https://510kreport.com/methodology