510(k) · Cleared

Cleared

Leva (TM) Spacer System

K141980510(k) TraditionalCleared Jan 26, 2015189-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

Spine Wave, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 26, 2015 as substantially equivalent to K083626 (Advanced Medical Technology, Inc., 2009) and 2 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.

Decided: Jan 26, 2015
Review: 189 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to P950019 (1996). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996 · Recalled
This deviceK141980 Leva (TM) Spacer SystemSpine Wave, Inc. · 2015
Descendant · cites it directly · 7 of its ownK150285 Leva (TM) Spacer SystemSpine Wave, Inc. · 2015
Descendant · cites it directly · 6 of its ownK151581 Leva Spacer SystemSpine Wave, Inc. · 2015
Descendant · 2 generations on · 5 of its ownK153222 Leva Spacer SystemSpine Wave, Inc. · 2016
Descendant · 3 generations on · 2 of its ownK231275 Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023
Descendant · 3 generations on · 1 of its ownK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all

K150285Leva (TM) Spacer SystemSpine Wave, Inc. · 2015 · cites it directly7descendants
K151581Leva Spacer SystemSpine Wave, Inc. · 2015 · cites it directly6descendants
K153222Leva Spacer SystemSpine Wave, Inc. · 2016 · 2 generations on5descendants
K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023 · 3 generations on2descendants
K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P950019	Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation	Stryker Spine	1996	1
0 (this device)	K141980	Leva (TM) Spacer System	Spine Wave, Inc.	2015	—
+1	K150285	Leva (TM) Spacer System	Spine Wave, Inc.	2015	—
+1	K151581	Leva Spacer System	Spine Wave, Inc.	2015	—
+2	K153222	Leva Spacer System	Spine Wave, Inc.	2016	—
+3	K231275	Exceed™ Biplanar Expandable Interbody System	Spine Wave, Inc.	2023	—
+3	K162760	Spine Wave Anterior Cervical Spine System	Spine Wave, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2016	1	0
2017	3	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K141980, 1996–2026Source: 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 MAX? 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 MAX device

#1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K083626	Distractable Wave Cage Summary page 4 …following predicates: Primary Predicate Device Manufacturer 510(k) No. Distractable Wave Cage AMT K083626 Additional Predicate Devices Manufacturer 510(k) No. Patriot™ Spacer Globus M…	Advanced Medical Technology, Inc.	2009	—
*	K072970	Patriot Spacers Summary page 4 …K083626 Additional Predicate Devices Manufacturer 510(k) No. Patriot™ Spacer Globus Medical K072970 Ray Threaded Fusion Cage Stryker Spine P950019…	Globus Medical, Inc.	2008	—
*	P950019	Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation Summary page 4 …urer 510(k) No. Patriot™ Spacer Globus Medical K072970 Ray Threaded Fusion Cage Stryker Spine P950019 K141980…	Stryker Spine	1996	1

Also cleared against K083626: 8 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K150285	Leva (TM) Spacer System	Spine Wave, Inc.	2015	7
K151581	Leva Spacer System	Spine Wave, Inc.	2015	6
K163246	Leva Anterior Expandable Spacer System	Spine Wave, Inc.	2017	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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K150285 (Spine Wave, Inc., 2015) has gone furthest, with 7 descendants of its own.
8 other devices also cite its predicate K083626.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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	7	86	0	12
2008	35	88	2	19
2009	31	102	9	90
2010	29	137	0	154
2011	49	98	3	201
2012	48	69	11 (1)	327
2013	58	102	0	380
2014	58	115	3	366
2015	53	113	1	524
2016	64	124	6	647
2017	76	116	1	596
2018	64	114	4	616
2019	60	131	1	699
2020	56	106	0	640
2021	53	109	0	622
2022	41	95	1	618
2023	30	87	0	576
2024	38	91	1	729
2025	29	85	5	811
2026	18	95	0	—

What is it indicated for?

The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degencrative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

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/K141980 · printed Nov 4, 2026

Cite this page

510(k) Report. “K141980: Leva (TM) Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141980

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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