# K011827: Ortelius 800

- Pathway: 510(k) (Traditional)
- Applicant: Orthoscan, Ltd.
- Decided: Aug 28, 2001 after 77 days
- Product code: KQX (Goniometer, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 888.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832494 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832494: Scoliometer, Orthopedic Systems, Inc. (1983) Summary page 2.
- K962377: 3D-Spine, Skill Technologies, Inc. (1996) Summary page 2.

## Indications for use
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis. The Ortelius 800 may be used in medical clinics/institutes.

Source page: https://510kreport.com/device/K011827
Methodology: https://510kreport.com/methodology