# K974406: Orthoplan

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Graphics, Inc.
- Decided: Feb 18, 1998 after 89 days
- Product code: HWT (Template)
- Device class: 1
- Regulation: 21 CFR 888.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the OrthoPlan software, to overlay the constructed images to aid surgeons in their planning of orthopaedic surgeries.

Source page: https://510kreport.com/device/K974406
Methodology: https://510kreport.com/methodology