510(k) · Cleared
ClearedLeva® Anterior Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Nov 22, 2016 as substantially equivalent to K082926 (Seaspine, Inc., 2008) and 6 other predicates after a 126-day review. Its family tree reaches back 16 generations to 1984.
- Decided
- Nov 22, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K841189 (1984). 151 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 2 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 1 generation backK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015 · Recalled
- This deviceK161993 Leva® Anterior Interbody SystemSpine Wave, Inc. · 2016
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 4 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 3 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 2 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 1 generation backK142487 Chesapeake Stabilization SystemK2m, Inc. · 2015 · Recalled
- This deviceK161993 Leva® Anterior Interbody SystemSpine Wave, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −4 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −3 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −2 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| −1 | K142487 | Chesapeake Stabilization System | K2m, Inc. | 2015 | 1 |
| 0 (this device) | K161993 | Leva® Anterior Interbody System | Spine Wave, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 19 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 10 | 0 |
| 2008 | 21 | 0 |
| 2009 | 11 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 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 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
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K082926 | Zuma, Model 55-XXXX/56-XXXXSummary page 4…rbody System described in this submission is substantially equivalent to the following predicates: Primary Predicate Device Manufacturer 510(k) No. Zuma System SeaSpine K 082926 Reference Predicate Devices Manufacturer 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Indepen… | 2008 |
| * | K130445 | Vault Alif SystemSummary page 4…es: Primary Predicate Device Manufacturer 510(k) No. Zuma System SeaSpine K 082926 Reference Predicate Devices Manufacturer 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The ST… | 2013 |
| * | K122168 | Visualif Challenging Access PlateSummary page 4…e Manufacturer 510(k) No. Zuma System SeaSpine K 082926 Reference Predicate Devices Manufacturer 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The STALIF TT™ Surgicraft Spine K0… | 2012 |
| * | K120101 | Independence SpacerSummary page 4…ma System SeaSpine K 082926 Reference Predicate Devices Manufacturer 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The STALIF TT™ Surgicraft Spine K073109 K16199… | 2012 |
| * | K133947 | Irix-a Lumbar Integrated Fusion SystemSummary page 4…2926 Reference Predicate Devices Manufacturer 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The STALIF TT™ Surgicraft Spine K073109 K161993 page 2 of 2 . Device… | 2014 |
| * | K142487 | Chesapeake Stabilization SystemSummary page 4…r 510(k) No. Vault ALIF System Precision Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The STALIF TT™ Surgicraft Spine K073109 K161993 page 2 of 2 . Device Description The Leva® Anterior Interbody S… | 2015 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 4…Spine K130445 VisuALIF SpineSmith K122168 Independence Globus K120101 Irix-A X-Spine K133947 Chesapeake Stabilization System K2M K142487 The STALIF TT™ Surgicraft Spine K073109 K161993 page 2 of 2 . Device Description The Leva® Anterior Interbody System is family of stand-alone lumbar in… | 2008 |
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 32 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 18 of the 151 ancestors have a recall of any class.
- 2 other devices also cite its predicate K082926.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 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 | — |
What is it indicated for?
The Leva® Anterior Interbody System is a stand-alone system 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…
Read the full statement (114 words)
The Leva® Anterior Interbody System is a stand-alone system 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® Anterior Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. 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/K161993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161993: Leva® Anterior Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161993
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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