510(k) · Cleared
ClearedLeva 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 Apr 15, 2016 as substantially equivalent to K151581 (Spine Wave, Inc., 2015) after a 161-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Apr 15, 2016
- Review
- 161 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P950019 (1996). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996 · Recalled
- 3 generations backK141980 Leva (TM) Spacer SystemSpine Wave, Inc. · 2015
- 2 generations backK150285 Leva (TM) Spacer SystemSpine Wave, Inc. · 2015
- 1 generation backK151581 Leva Spacer SystemSpine Wave, Inc. · 2015
- This deviceK153222 Leva Spacer SystemSpine Wave, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK231275 Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK261159 Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243816 Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023 · cites it directly2descendants
- K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017 · cites it directly1descendant
- K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2026 · 2 generations on0descendants
- K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025 · 2 generations on0descendants
- K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | Stryker Spine | 1996 | 1 |
| −3 | K141980 | Leva (TM) Spacer System | Spine Wave, Inc. | 2015 | — |
| −2 | K150285 | Leva (TM) Spacer System | Spine Wave, Inc. | 2015 | — |
| −1 | K151581 | Leva Spacer System | Spine Wave, Inc. | 2015 | — |
| 0 (this device) | K153222 | Leva Spacer System | Spine Wave, Inc. | 2016 | — |
| +1 | K231275 | Exceed™ Biplanar Expandable Interbody System | Spine Wave, Inc. | 2023 | — |
| +1 | K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +2 | K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026 | — |
| +2 | K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025 | — |
| +2 | K173175 | Paramount Anterior Cervical Cage 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151581 | Leva Spacer SystemSummary page 4…following predicates: Primary Predicate Device Manufacturer 510(k) No. Leva® Spacer System Spine Wave, Inc. K151581 Reference Predicate Devices Manufacturer 510(k) No. Patriot Spacer Globus… | 2015 |
| † | K122097 | Patriot Spacers | 2012 |
| † | K152620 | Spine Wave Gen II Expandable Interbody System | 2016 |
What descends from it? (5)
2 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K231275 (Spine Wave, Inc., 2023) has gone furthest, with 2 descendants of its own.
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. 2016, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153222: Leva Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153222
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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