# K103400: Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 7, 2011 after 108 days
- Product code: OLO (Orthopedic 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: 9 generations back to K911783 (1994). 38 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062358: Modification to Vectorvision Trauma, Brainlab AG (2007) Summary page 1.
- K102130: Tenzing System, Mazor Surgical Technologies, Ltd. (2010) Summary page 1.
- K020677: Gamma 3 Lag Screw, Howmedica Osteonics Corp. (2002) Summary page 1.
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K173946: ADAPT for Gamma3 (2018), 2 descendants of its own
- K182359: HipCheck (2018), 1 descendant of its own
- K181848: ADAPT for Gamma3, Gamma3 (2018), 1 descendant of its own
- K230045: HipCheck (2023), 0 descendants of its own
- K202749: ADAPT for Gamma3 (2020), 0 descendants of its own

## Indications for use
FluoroMap is a computer controlled stereotaxic image guided surgery system. It provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images. FluoroMap assists the surgeon to determine the needed size and position of orthopedic implants during proximal femur fracture surgery using the Stryker Gamma3 Nail system. The system should be operated only by trained personnel such as surgeons and clinic staff.

Source page: https://510kreport.com/device/K103400
Methodology: https://510kreport.com/methodology