# K050751: Impax Orthopaedic Workstation, Model Impax ES 5.X

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Apr 21, 2005 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010612 (2001). 3 ancestors in all.
135 later devices descend from it; 2 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014113: Endomap, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

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

## Recalls of this device
- Jun 28, 2007 · Not classified · Z-1245-2008: Text and Images may not be synchronized.
- May 14, 2007 · Not classified · Z-1243-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
- May 14, 2007 · Not classified · Z-1244-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

## Indications for use
The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic PACS application provides digital planning to images acquired through the system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can also be shown to patients to explain the procedure they will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. Templates are patterns or guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Source page: https://510kreport.com/device/K050751
Methodology: https://510kreport.com/methodology