510(k) · Cleared
ClearedZimmer Mis Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · FST Light, Surgical, Fiberoptic
Cleared on Feb 22, 2008 as substantially equivalent to K042034 (Nuvasive, Inc., 2004) after a 10-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it.
- Decided
- Feb 22, 2008
- Review
- 10 days
- Class
- Class II
- Product code
- FST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042034 (2004). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK042034 Nuvasive Maxcess Light GuideNuvasive, Inc. · 2004
- This deviceK080367 Zimmer Mis LightZimmer Spine, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK082992 Axxion Light GuideSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK101496 Cablecap Model: WLF, STZ, AcmSensormed · 2010
- Descendant · cites it directly · 0 of its ownK122637 Lite Decompression System- Light Cable Model 48089999Stryker Spine · 2012
- Descendant · 3 generations on · 0 of its ownK113330 CablecapSensormed · 2012
- Descendant · cites it directly · 0 of its ownK090070 Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K082992Axxion Light GuideSpinal Elements, Inc. · 2009 · cites it directly2descendants
- K101496Cablecap Model: WLF, STZ, AcmSensormed · 2010 · 2 generations on1descendant
- K122637Lite Decompression System- Light Cable Model 48089999Stryker Spine · 2012 · cites it directly0descendants
- K113330CablecapSensormed · 2012 · 3 generations on0descendants
- K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042034 | Nuvasive Maxcess Light Guide | Nuvasive, Inc. | 2004 | — |
| 0 (this device) | K080367 | Zimmer Mis Light | Zimmer Spine, Inc. | 2008 | — |
| +1 | K082992 | Axxion Light Guide | Spinal Elements, Inc. | 2009 | — |
| +2 | K101496 | Cablecap Model: WLF, STZ, Acm | Sensormed | 2010 | — |
| +1 | K122637 | Lite Decompression System- Light Cable Model 48089999 | Stryker Spine | 2012 | — |
| +3 | K113330 | Cablecap | Sensormed | 2012 | — |
| +1 | K090070 | Invuity Britefield Mcculloch Retractor System | Invuity, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K042034 | Nuvasive Maxcess Light GuideSummary page 1…tion Number: 21 CFR 878.4580 Device Classification: Class II Predicate Devices: NuVasive MaXcess Light Guide, K042034 Description of Device: The Zimmer MIS Light consists of fiber optic cables contained within silicone tubing which can be conne… | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FST devicesFST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Zimmer MIS Light 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/K080367 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080367: Zimmer Mis Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080367
Report an extraction error
Are you the manufacturer?
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