# K041162: Ortho-CMS

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Jul 27, 2004 after 85 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). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 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 1.
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K042383: Rsa-CMS (2004), 1 descendant of its own
- K133966: Model-Based Rsa Software (2014), 0 descendants of its own

## Indications for use
Ortho-CMS is an orthopaedic analysis software tool. It has been developed to optimize preoperative planning through digital prosthesis templating and to enable preoperative and postoperative measurements in digital or digitized X-Ray images. Ortho-CMS software is meant solely for use by trained medical personnel. The intended purposes of Ortho-CMS are: Displaying of X-Ray images Supporting planning of joint replacement operations Supporting clinical diagnoses on implant loosening Enabling preoperative and postoperative measurements for clinical and research purposes

Source page: https://510kreport.com/device/K041162
Methodology: https://510kreport.com/methodology