# K140434: Medicad Classic

- Pathway: 510(k) (Traditional)
- Applicant: Hectec GmbH
- Decided: Jun 5, 2014 after 105 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.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 2.
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 3.

## Indications for use
The mediCAl) classic V3.0 is a medical stand-alone software, which allows professional orthopedics preoperative measurements of existing x-rays. The software is intended to read in diagnostic images (e.g. digitized x-rays) from PACS-systems or conventional medias and to dimension them. An integrated database of orthopedic implant geometries can be overlayed to aid surgeons in their planning of orthopedic surgeries. mediCAD classic 3.0 can hand over the digital plannings as DICOMs to PACS-systems. Federal law restricts this device to sale by or on the order of a health professional. mediCAD will also support the proper workflow necessary to effectively compare pre and post-operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy. The system is designed for the following medical specialties: * Orthopedics * Surgery and Traumnatology * Rheumatology * Pediatric Orthopedics MediCAD is designed for pretoperative planning for the following applications: * Hip - Manual Planning * Hip - Automatic Planning * Hip - Biometry * Hip - Coxometry * Hip - Wear Measurement * Hip -FAI Knee Prosthetic Planning Biometry Planning -takes into account patient motion and metrics * Coxometry - tracking of known measurement values in pediatrics to determine surgical intervention * Osteotomy - determines optimum osteotomy locations * Osteotomy by Dror Paley Osteotomy (DualSide) * Spine * Foot * Upper Extremities Biological Age Determination by Hand * Trauma

Source page: https://510kreport.com/device/K140434
Methodology: https://510kreport.com/methodology