510(k) · Cleared
ClearedLeva (TM) Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 5, 2015 as substantially equivalent to K141980 (Spine Wave, Inc., 2015) after a 28-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it.
- Decided
- Mar 5, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950019 (1996). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996 · Recalled
- 1 generation backK141980 Leva (TM) Spacer SystemSpine Wave, Inc. · 2015
- This deviceK150285 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
- Descendant · 4 generations on · 0 of its ownK261159 Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | Stryker Spine | 1996 | 1 |
| −1 | K141980 | Leva (TM) Spacer System | Spine Wave, Inc. | 2015 | — |
| 0 (this device) | 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 | — |
| +4 | K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026 | — |
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 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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
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 |
|---|---|---|---|
| * | K141980 | Leva (TM) Spacer SystemSummary page 4…following predicates: Primary Predicate Device Manufacturer 510(k) No. Leva™ Spacer System Spine Wave, Inc. K141980 K150285 - Page 2 of 2 5. Devi… | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151581 | Leva Spacer System | 2015 | 6 |
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 19 years and passes through 2 companies; a new generation was cleared every 18.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151581 (Spine Wave, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K141980.
How does its category compare?
All MAX devicesMAX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 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. Degenerative 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 as stated in the FDA summary.
https://510kreport.com/device/K150285 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150285: Leva (TM) Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150285
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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