510(k) · Cleared
ClearedGenesys Spine AIS-C Cervical Anchored Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Mar 28, 2018 as substantially equivalent to K152099 (Genesys Spine, 2016) and 5 other predicates after a 79-day review. Its family tree reaches back 15 generations to 1984. 18 later devices descend from it.
- Decided
- Mar 28, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 132 ancestors in all, the oldest K792352 (1979). 18 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- This deviceK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
- Descendant · cites it directly · 17 of its ownK181295 Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine · 2018
- Descendant · 2 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 2 generations on · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- This deviceK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine · 2018 · cites it directly17descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 2 generations on7descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · 2 generations on7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −3 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −2 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −1 | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation | Spineart | 2014 | — |
| 0 (this device) | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | 2018 | — |
| +1 | K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine | 2018 | — |
| +2 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +2 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +2 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
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 | 11 | 0 |
| 2004 | 21 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 18 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemSummary page 4…ion Panel: Orthopedic Devices Panel Legally Marketed Primary Predicate: Genesys Spine Apache® Anchored Cervical (unmodified) devices Interbody Fusion System (K152099) to Which Substantial Equivalence is Additional Predicates: LDR Spine Cervical Interbody Fusion System – Claimed:… | 2016 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 4…y Fusion System (K152099) to Which Substantial Equivalence is Additional Predicates: LDR Spine Cervical Interbody Fusion System – Claimed: ROI-C (K091088, K113559), Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior… | 2009 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 4…System (K152099) to Which Substantial Equivalence is Additional Predicates: LDR Spine Cervical Interbody Fusion System – Claimed: ROI-C (K091088, K113559), Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical… | 2011 |
| * | K132582 | Exactech Acapella One Cervical Spacer SystemSummary page 4…tes: LDR Spine Cervical Interbody Fusion System – Claimed: ROI-C (K091088, K113559), Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K10… | 2014 |
| * | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSummary page 4…, K113559), Exactech Acapella One Cervical Spacer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034)… | 2014 |
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 4…cer System (K132582), SpineArt Scarlet AC-T Secured Anterior Cervical Cage (K141314), Genesys Spine Apache® IBFD System, (K103034) K180056- Page 2 of 3 D ESCRI… | 2010 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | 2018 | 17 |
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 34 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
- 19 of the 132 ancestors have a recall of any class.
- Of its descendants, K181295 (Genesys Spine, 2018) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K152099.
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. 2018, 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 Genesys Spine AIS-C Cervical Anchored Interbody 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. The system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
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/K180056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180056: Genesys Spine AIS-C Cervical Anchored Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180056
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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