510(k) · Cleared
ClearedParamount Anterior Cervical Cage 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 Nov 1, 2017 as substantially equivalent to K162760 (Spine Wave, Inc., 2017) after a 33-day review. Its family tree reaches back 18 generations to 1984.
- Decided
- Nov 1, 2017
- Review
- 33 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K841189 (1984). 116 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- 2 generations backK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- 1 generation backK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- This deviceK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 14 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 13 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 12 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 10 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 9 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 8 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 7 generations backK113527 Opticage Interbody Fusion DeviceInterventional Spine, Inc. · 2012
- 6 generations backK123461 Staxx (R) IB SystemSpine Wave, Inc. · 2013 · Recalled
- 5 generations backK131071 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 4 generations backK132719 Staxx Ibl SystemSpine Wave, Inc. · 2013
- 3 generations backK140007 Abacus TM Spacer SystemSpine Wave, Inc. · 2014
- 2 generations backK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- 1 generation backK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- This deviceK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −14 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −13 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −12 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −10 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −9 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −8 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −7 | K113527 | Opticage Interbody Fusion Device | Interventional Spine, Inc. | 2012 | — |
| −6 | K123461 | Staxx (R) IB System | Spine Wave, Inc. | 2013 | 1 |
| −5 | K131071 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −4 | K132719 | Staxx Ibl System | Spine Wave, Inc. | 2013 | — |
| −3 | K140007 | Abacus TM Spacer System | Spine Wave, Inc. | 2014 | — |
| −2 | K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016 | — |
| −1 | K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K162760 | Spine Wave Anterior Cervical Spine SystemSummary page 4…he following: Primary Predicate Device Manufacturer 510(k) No. Spine Wave Anterior Cervical Spine System Spine Wave, Inc. K162760 5. Device Description The Paramount® Anterior Cervical Cage System consists of a selection of sterile, single use cervic… | 2017 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 116 ancestors have a recall of any class.
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 Paramount® Anterior Cervical Cage 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. Paramount® Anterior Cervical Cage 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 as stated in the FDA summary.
https://510kreport.com/device/K173175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173175: Paramount Anterior Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173175
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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