510(k) · Cleared
Cleared3D-Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skill Technologies, Inc. · KQX Goniometer, Ac-Powered
Cleared on Sep 3, 1996 after a 75-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 3, 1996
- Review
- 75 days
- Class
- Class I
- Product code
- KQX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK962377 3D-SpineSkill Technologies, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK011827 Ortelius 800Orthoscan, Ltd. · 2001
Most influential descendants
Showing 1 of 1 · See all- K011827Ortelius 800Orthoscan, Ltd. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962377 | 3D-Spine | Skill Technologies, Inc. | 1996 | — |
| +1 | K011827 | Ortelius 800 | Orthoscan, Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | — | CA-6000 Spine Motion Analyzer Named without a submission number | |
| * | — | CP-2000 Compu-Plotter Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011827 | Ortelius 800 | 2001 | 0 |
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?
- Of its descendants, K011827 (Orthoscan, Ltd., 2001) has gone furthest, with 0 descendants of its own.
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?
3D-SPINE has the same intended use as a predicate device called the CA-6000 Spine Motion Analyzer. 3D-SPINE however, uses a different technological methodology to achieve the same results as the CA-6000. The technology used in the 3D-SPINE is the same as that used in a second predicate device called the CP-2000 Compu-Plotter, a 3D contour plotting and data gathering device. 3D-SPINE combines and produces the desired indications of the CA-6000 by using the superior features of the electromagnetic tracking principle used in the CP-2000.
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/K962377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962377: 3D-Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962377
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026