# K014113: Endomap

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 14, 2002 after 182 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: 1 generation back to K010612 (2001). 2 ancestors in all.
139 later devices descend from it; 2 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010612: Vectorvision Knee, Brainlab AG (2001)
- K010602: Vectorvision Hip, Brainlab AG (2001)

## Most influential descendants
- K050751: Impax Orthopaedic Workstation, Model Impax ES 5.X (2005), 135 descendants of its own
- K071972: Orthopedic Software for Impax Workstations (2007), 133 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

## Indications for use
The EndoMap package is an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. The software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the EndoMap software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

Source page: https://510kreport.com/device/K014113
Methodology: https://510kreport.com/methodology