510(k) · Cleared
ClearedAxxion Light Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Feb 18, 2009 as substantially equivalent to K904378 (Fiberoptics Technology, Inc., 1991) and 2 other predicates after a 134-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K042034 (2004). 3 ancestors in all, the oldest K904378 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK042034 Nuvasive Maxcess Light GuideNuvasive, Inc. · 2004
- 1 generation backK080367 Zimmer Mis LightZimmer Spine, Inc. · 2008
- This deviceK082992 Axxion Light GuideSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101496 Cablecap Model: WLF, STZ, AcmSensormed · 2010
- Descendant · 2 generations on · 0 of its ownK113330 CablecapSensormed · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042034 | Nuvasive Maxcess Light Guide | Nuvasive, Inc. | 2004 | — |
| −1 | K080367 | Zimmer Mis Light | Zimmer Spine, Inc. | 2008 | — |
| 0 (this device) | K082992 | Axxion Light Guide | Spinal Elements, Inc. | 2009 | — |
| +1 | K101496 | Cablecap Model: WLF, STZ, Acm | Sensormed | 2010 | — |
| +2 | K113330 | Cablecap | Sensormed | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 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 FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FST device
- #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K904378 | F.T.I. Medical Light GuideSummary page 2…tially equivalent in design, technical requirements, materials, and intended use to the following predicate devices: Medical Light Guide by Fiberoptics Technology, Inc. (K904378), MIS Light by Zimmer (K080367), and MaZcess Light Guide by NuVasive (K042034). ~~~~J.~ ~ ~… | 1991 |
| * | K080367 | Zimmer Mis LightSummary page 2…chnical requirements, materials, and intended use to the following predicate devices: Medical Light Guide by Fiberoptics Technology, Inc. (K904378), MIS Light by Zimmer (K080367), and MaZcess Light Guide by NuVasive (K042034). ~~~~J.~ ~ ~ i DEPARTMENT OF HEALTH &… | 2008 |
| * | K042034 | Nuvasive Maxcess Light GuideSummary page 2…se to the following predicate devices: Medical Light Guide by Fiberoptics Technology, Inc. (K904378), MIS Light by Zimmer (K080367), and MaZcess Light Guide by NuVasive (K042034). ~~~~J.~ ~ ~ i DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101496 | Cablecap Model: WLF, STZ, Acm | 2010 | 1 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101496 (Sensormed, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FST
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FST
59in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FST
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FST
27in 2025
MAUDE reports naming product code FST, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 3 | 100 | 0 | 4 |
| 2010 | 5 | 90 | 0 | 3 |
| 2011 | 0 | — | 10 | 7 |
| 2012 | 3 | 59 | 0 | 14 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 1 | 13 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082992: Axxion Light Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082992
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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