510(k) · Cleared
ClearedGenesys Spine AIS-C Cervical Stand-Alone 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 Aug 29, 2018 as substantially equivalent to K113559 (Ldr Spine USA, Inc., 2011) and 3 other predicates after a 105-day review. Its family tree reaches back 16 generations to 1984. 17 later devices descend from it.
- Decided
- Aug 29, 2018
- Review
- 105 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 133 ancestors in all, the oldest K792352 (1979). 17 later devices descend from it, 5 citing it directly.
- 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 backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- 1 generation backK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
- This deviceK181295 Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine · 2018
- Descendant · cites it directly · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · cites it directly · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · cites it directly · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 2 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
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 backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- 1 generation backK180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine · 2018
- This deviceK181295 Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · cites it directly7descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · cites it directly7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · cites it directly6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on3descendants
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 | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation | Spineart | 2014 | — |
| −1 | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody System | Genesys Spine | 2018 | — |
| 0 (this device) | K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine | 2018 | — |
| +1 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +1 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +1 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +2 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
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 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 4…E Classification Panel: Orthopedic Devices Panel Legally Marketed Primary Predicate: (unmodified) devices LDR Spine Cervical Interbody Fusion System – ROI-C (K113559) to Which Substantial Equivalence is Additional Predicate Devices: Claimed: Genesys Spine AIS-C Anchored… | 2011 |
| * | K180056 | Genesys Spine AIS-C Cervical Anchored Interbody SystemSummary page 4…tial Equivalence is Additional Predicate Devices: Claimed: Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056) Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099)… | 2018 |
| * | K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemSummary page 4…nterbody Fusion System (K180056) Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099) Genesys Spine Apache® IBFD System (K103034)… | 2016 |
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 4…Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099) Genesys Spine Apache® IBFD System (K103034) K181295- Page 2 of 3 D… | 2010 |
What descends from it? (17)
See all 175 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 34 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
- 19 of the 133 ancestors have a recall of any class.
- Of its descendants, K191489 (Genesys Spine, 2020) has gone furthest, with 7 descendants of its own.
- 20 other devices also cite its predicate K113559.
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 Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one 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 had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181295: Genesys Spine AIS-C Cervical Stand-Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181295
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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