# K063327: Orthoview

- Pathway: 510(k) (Traditional)
- Applicant: Merdian Technique, Ltd.
- Decided: Nov 22, 2006 after 19 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: 7 generations back to K896095 (1990). 10 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042816: Traumacad 1.2, Orthocrat, Ltd. (2004) Summary page 1.
- K032401: Orthoview, Omsbar, Ltd. (2003) Summary page 1.

## Most influential descendants
- K133022: Zedview (2014), 10 descendants of its own
- K171847: Corin Optimized Positioning System (OPS™) Plan (2018), 6 descendants of its own
- K183038: Corin Optimized Positioning System (OPS) Plan (2018), 5 descendants of its own
- K192656: Optimized Positioning System (OPS) Insight (2020), 3 descendants of its own
- K211429: NAVIPLAN - CT Planning Software for Total Hip Replacement (2021), 0 descendants of its own

## Indications for use
OrthoviewTM is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.

Source page: https://510kreport.com/device/K063327
Methodology: https://510kreport.com/methodology