510(k) · Cleared
ClearedOrtelius 800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthoscan, Ltd. · KQX Goniometer, Ac-Powered
Cleared on Aug 28, 2001 as substantially equivalent to K832494 (Orthopedic Systems, Inc., 1983) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Aug 28, 2001
- Review
- 77 days
- Class
- Class I
- Product code
- KQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832494 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832494 ScoliometerOrthopedic Systems, Inc. · 1983
- This deviceK011827 Ortelius 800Orthoscan, Ltd. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832494 | Scoliometer | Orthopedic Systems, Inc. | 1983 | — |
| 0 (this device) | K011827 | Ortelius 800 | Orthoscan, Ltd. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K832494 | ScoliometerSummary page 2…X, Regulation No. 888.1500) and they are reviewed by the Orthopedic Panel. 7-3 - Predicate Device: . Orthopedic Systems, Inc. Scoliometer cleared under K832494 . Skill Technologies, 3D-SPINE, cleared under K962377 Performance Standards: No performance standards have been established fo… | 1983 |
| * | K962377 | 3D-SpineSummary page 2…e Orthopedic Panel. 7-3 - Predicate Device: . Orthopedic Systems, Inc. Scoliometer cleared under K832494 . Skill Technologies, 3D-SPINE, cleared under K962377 Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Dr… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All KQX devicesKQX Goniometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQX
FDA has decided no KQX device since 2007.
Median 510(k) review, days · KQX
Too few KQX 510(k)s in any year since 2007 to give a median.
Recalls per year · KQX
No recall names KQX since 2007.
Adverse event reports per year · KQX
No MAUDE report names KQX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011827: Ortelius 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011827
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026