# K042867: Philips Orthopaedic Applications

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Nov 2, 2004 after 15 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: 5 generations back to K913475 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040344: Impax OT3000 Orthopedic Workstation, Agfa Corp. (2004). Our reading of the summary gave K040334, FDA’s number for Navigus Passive Probe, Model NP-1000 (Image-Guided Neurologics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Agfa IMPAX® OT3000 Orthopedic Workstation”.
- K031590: Sectra Orthopedic Package, Sectra-Imtec AB (2003) Summary page 2.

## Most influential descendants
- K060210: Mediport (2006), 0 descendants of its own

## Indications for use
Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as orthopaedic surgeons, physicians and radiologists in planning and evaluating orthopaedic procedures using medical images. The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.

Source page: https://510kreport.com/device/K042867
Methodology: https://510kreport.com/methodology