510(k) · Cleared
ClearedSpine Wave Anterior Cervical Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 16, 2017 as substantially equivalent to K150765 (Ldr Spine USA, 2015) and 4 other predicates after a 139-day review. Its family tree reaches back 17 generations to 1984. 1 later device descends from it.
- Decided
- Feb 16, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 115 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 2 generations backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- 1 generation backK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- This deviceK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 13 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 12 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 11 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 9 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 8 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 7 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 6 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 5 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 4 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 3 generations backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 2 generations backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- 1 generation backK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- This deviceK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −13 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −12 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −11 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −9 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −8 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −7 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −6 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −5 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| −4 | K131071 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −3 | K132719 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −2 | K140007 | Abacus TM Spacer System | Spine Wave, Inc. | 2014 | — |
| −1 | K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016 | — |
| 0 (this device) | K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +1 | K173175 | Paramount Anterior Cervical Cage System | Spine Wave, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 9 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K150765 | LDR Spine ROI-C Cervical Cage SystemSummary page 4…m described in this submission is substantially equivalent to the following: Primary Predicate Device Manufacturer 510(k) No. ROI-C Cervical Cage System LDR Spine USA | K150765 Additional Predicate Devices Manufacturer 510(k) No. Cervical Interbody Spacer System Choice Spine K091531 Gen II Expandable Inte… | 2015 |
| * | K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody SpacerSummary page 4…facturer 510(k) No. ROI-C Cervical Cage System LDR Spine USA | K150765 Additional Predicate Devices Manufacturer 510(k) No. Cervical Interbody Spacer System Choice Spine K091531 Gen II Expandable Interbody System Spine Wave K152620 Leva® Interbody Device Spine Wave K153222 CapSure® PS Spine System Spine Wa… | 2009 |
| * | K152620 | Spine Wave Gen II Expandable Interbody SystemSummary page 4…ne USA | K150765 Additional Predicate Devices Manufacturer 510(k) No. Cervical Interbody Spacer System Choice Spine K091531 Gen II Expandable Interbody System Spine Wave K152620 Leva® Interbody Device Spine Wave K153222 CapSure® PS Spine System Spine Wave K081228 4. Device Description The Spine Wave Ante… | 2016 |
| * | K153222 | Leva Spacer SystemSummary page 4…ces Manufacturer 510(k) No. Cervical Interbody Spacer System Choice Spine K091531 Gen II Expandable Interbody System Spine Wave K152620 Leva® Interbody Device Spine Wave K153222 CapSure® PS Spine System Spine Wave K081228 4. Device Description The Spine Wave Anterior Cervical Spine (ACS) System consists… | 2016 |
| * | K081228 | Capsure PS (R) Spine SystemSummary page 4…dy Spacer System Choice Spine K091531 Gen II Expandable Interbody System Spine Wave K152620 Leva® Interbody Device Spine Wave K153222 CapSure® PS Spine System Spine Wave K081228 4. Device Description The Spine Wave Anterior Cervical Spine (ACS) System consists of a selection of non-sterile, single use ce… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173175 | Paramount Anterior Cervical Cage System | 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?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 115 ancestors have a recall of any class.
- Of its descendants, K173175 (Spine Wave, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K150765.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Spine Wave Anterior Cervical Spine System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Spine Wave Anterior Cervical Spine System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.
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/K162760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162760: Spine Wave Anterior Cervical Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162760
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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