# K071972: Orthopedic Software for Impax Workstations

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corp.
- Decided: Jul 30, 2007 after 13 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: 4 generations back to K904519 (1991). 10 ancestors in all.
133 later devices descend from it; 7 cite it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050751: Impax Orthopaedic Workstation, Model Impax ES 5.X, Agfa Corp. (2005) Summary page 2.
- K022881: Cedara I-Softview, Cedara Software Corp. (2002) Summary page 2.

## Most influential descendants
- 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
- K141669: Surgimap (2014), 27 descendants of its own
- K160284: JointPoint (2016), 21 descendants of its own

## Indications for use
Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information. The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment. It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.

Source page: https://510kreport.com/device/K071972
Methodology: https://510kreport.com/methodology