# K042543: Iplan! Digital Templating

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 17, 2005 after 239 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983410 (1999). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020631: IPLAN, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K080608: Digital Lightbox (2008), 6 descendants of its own
- K093117: Digital Lightbox (2009), 5 descendants of its own
- K153653: DICOM Viewer (2016), 4 descendants of its own
- K191014: Elements Viewer (2020), 3 descendants of its own
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2024), 1 descendant of its own

## Indications for use
The iPlan Hip Templating system is indicated for the preoperative planning of orthopedic treatments. It is specially developed for the preparation and display of anatomical patient data that has been acquired using x-ray, CT or MR equipment. iPlan Hip Templating creates treatment plans in conjunction with 2D / 3D implant models. Implant models are provided by a separate database-Both 2D and 3D planning are supported, depending on the anatomical information available. The treatment plan can either be saved or printed as required.

Source page: https://510kreport.com/device/K042543
Methodology: https://510kreport.com/methodology