# K120115: Orthosize

- Pathway: 510(k) (Traditional)
- Applicant: Orthosize, LLC
- Decided: Mar 14, 2012 after 61 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 1.

## Recalls of this device
- Feb 14, 2017 · Class II · Z-1495-2017: Digital templates were created with the incorrect files.

## Indications for use
Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.

Source page: https://510kreport.com/device/K120115
Methodology: https://510kreport.com/methodology