510(k) · Cleared
ClearedGenesys Spine AIS-C II Cervical Interbody Fusion 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 Feb 7, 2025 as substantially equivalent to K181295 (Genesys Spine, 2018) and 1 other predicate after a 170-day review. Its family tree reaches back 26 generations to 1984. 1 of the 365 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 7, 2025
- Review
- 170 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 26 generations to K841189 (1984). 364 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 365 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 2 generations backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- 1 generation backK233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
- This deviceK242483 Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine · 2025
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 8 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 7 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 6 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 5 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 4 generations backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- 3 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 2 generations backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- 1 generation backK233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
- This deviceK242483 Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −8 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −7 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −6 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −5 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| −4 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| −3 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| −2 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| −1 | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine | 2023 | — |
| 0 (this device) | K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 18 | 0 |
| 2004 | 29 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 16 | 0 |
| 2008 | 50 | 1 |
| 2009 | 28 | 0 |
| 2010 | 18 | 0 |
| 2011 | 30 | 0 |
| 2012 | 15 | 0 |
| 2013 | 18 | 0 |
| 2014 | 16 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K181295 | Genesys Spine AIS-C Cervical Stand-Alone SystemSummary page 5…3080 Product Code(s) OVE, ODP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181295 Genesys Spine AlIS-C Cervical Stand-Alone System OVE K233594 Genesys Spine 3DP AIS-C Il Cervical Interbody System OVE Device Desc… | 2018 |
| * | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemSummary page 5…evices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181295 Genesys Spine AlIS-C Cervical Stand-Alone System OVE K233594 Genesys Spine 3DP AIS-C Il Cervical Interbody System OVE Device Description Summary 21 CFR 807.92(a)(4) GENERAL OVERVIEW The Gen… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 50 of the 364 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K181295.
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. 2025, 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?
When used with the integrated fixation and as a standalone system: The Genesys Spine AIS-C Il Cervical Interbody Fusion System is a standalone 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…
Read the full statement (189 words)
When used with the integrated fixation and as a standalone system:
The Genesys Spine AIS-C Il Cervical Interbody Fusion System is a standalone 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 AIS-C Il Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the integrated fixation:
The Genesys Spine AIS-C Il Cervical Interbody Fusion 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 device 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/K242483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242483: Genesys Spine AIS-C II Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242483
Report an extraction error
Are you the manufacturer?
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