510(k) · Cleared

Cleared

Aero-AL Lumbar Cage System

K133328510(k) TraditionalCleared May 30, 2014213-day reviewClass II21 CFR 888.3080

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

Stryker Corporation · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on May 30, 2014 after a 213-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 638 later devices descend from it.

Decided: May 30, 2014
Review: 213 days
Class: Class II
Product code: OVD
Recalls: None
Predicates: 0

638 later devices descend from it, 2 citing it directly.

This deviceK133328 Aero-AL Lumbar Cage SystemStryker Corporation · 2014
Descendant · cites it directly · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
Descendant · 2 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
Descendant · 2 generations on · 448 of its ownK152304 Tritanium PL CageStryker · 2015 · Recalled
Descendant · 2 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Descendant · 3 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016

Showing 5 of 638 descendants. See all descendants

Descendants cleared per year

2014high 83 (2023) · low 1 (2014)2026

Most influential descendants

Showing 5 of 638 · See all

K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · cites it directly636descendants
K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 2 generations on469descendants
K152304Tritanium PL CageStryker · 2015 · 2 generations on448descendants
K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on390descendants
K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on381descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K133328	Aero-AL Lumbar Cage System	Stryker Corporation	2014	—
+1	K143163	AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…	Stryker Corporation	2015	—
+2	K143616	AccuLIF TL and PL Cage	Stryker Corporation	2015	4
+2	K152304	Tritanium PL Cage	Stryker	2015	1
+2	K153782	NuVasive® Lumbar Interbody Implants	Nu Vasive, Incorporated	2016	—
+3	K161230	NuVasive Lumbar Interbody Implants	Nu Vasive, Incorporated	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	6	0
2016	17	0
2017	37	0
2018	40	0
2019	53	0
2020	68	0
2021	56	0
2022	69	0
2023	83	0
2024	83	0
2025	68	0
2026	57	0

FIG. 1 — Lineage of K133328, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OVD? 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 OVD device

#1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (638)

See all 638

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K143163	AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…	Stryker Corporation	2015	636
K142066	Aero-LL Lumbar Cage System	Stryker Corporation	2014	2

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, K143163 (Stryker Corporation, 2015) has gone furthest, with 636 descendants of its own.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OVD

50in 2025

2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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	2	—	0	0
2008	8	84	0	0
2009	3	152	0	2
2010	8	117	0	2
2011	9	167	0	6
2012	10	78	0	16
2013	11	137	4	17
2014	14	139	0	35
2015	12	166	0	43
2016	13	127	1	55
2017	12	127	0	72
2018	14	126	0	112
2019	12	91	0	171
2020	14	91	0	203
2021	7	108	1	221
2022	14	133	1	74
2023	12	92	0	67
2024	12	110	0	92
2025	10	100	1	50
2026	8	93	1	—

https://510kreport.com/device/K133328 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133328: Aero-AL Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133328

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026