510(k) · Cleared

Cleared

Lite Decompression System- Light Cable Model 48089999

K122637510(k) TraditionalCleared Nov 1, 201264-day reviewClass II21 CFR 878.4580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Spine · FST Light, Surgical, Fiberoptic

Cleared on Nov 1, 2012 as substantially equivalent to K042034 (Nuvasive, Inc., 2004) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 2004.

Decided: Nov 1, 2012
Review: 64 days
Class: Class II
Product code: FST
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K042034 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK042034 Nuvasive Maxcess Light GuideNuvasive, Inc. · 2004
1 generation backK080367 Zimmer Mis LightZimmer Spine, Inc. · 2008
This deviceK122637 Lite Decompression System- Light Cable Model 48089999Stryker Spine · 2012

View 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)	K122637	Lite Decompression System- Light Cable Model 48089999	Stryker Spine	2012	—

FIG. 1 — Lineage of K122637, 2004–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K042034	Nuvasive Maxcess Light Guide Summary page 1 …21 CFR 878.4580 Common Name Surgical lamp Product Code FST Predicate Devices NuVasive MaXcess Light Guide: K042034 Zimmer MIS Light: K080367 Device Description The Stryker Spine LlTeo Decompression Sys…	Nuvasive, Inc.	2004	—
*	K080367	Zimmer Mis Light Summary page 1 …Surgical lamp Product Code FST Predicate Devices NuVasive MaXcess Light Guide: K042034 Zimmer MIS Light: K080367 Device Description The Stryker Spine LlTeo Decompression System - Light Cable is a sin…	Zimmer Spine, Inc.	2008	—

Also cleared against K042034: 4 other devices →

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K042034.

How does its category compare?

All FST devices

FST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FST

1in 2020

2007high 5 (2010) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FST

59in 2012

2007high 100 (2009) · low 59 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FST

1in 2014

2007high 10 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FST

27in 2025

2007high 40 (2024) · low 2 (2008)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 Stryker Spine LITe Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122637 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122637: Lite Decompression System- Light Cable Model 48089999.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122637

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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