510(k) · Cleared
ClearedEndeavor™ Stand-Alone Cervical IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Sep 25, 2025 as substantially equivalent to K181115 (Innovasis, Inc., 2018) and 4 other predicates after a 258-day review. Its family tree reaches back 23 generations to 1984. 1 of the 405 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 25, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 23 generations to K841189 (1984). 404 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 405 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 2 generations backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- 1 generation backK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- This deviceK250076 Endeavor™ Stand-Alone Cervical IBF SystemInnovasis · 2025
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 13 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 12 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 11 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 10 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 9 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 8 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 7 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 6 generations backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- 5 generations backK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- 4 generations backK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- 3 generations backK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- 2 generations backK193636 SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
- 1 generation backK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- This deviceK250076 Endeavor™ Stand-Alone Cervical IBF SystemInnovasis · 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 |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −13 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −12 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −11 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −10 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −9 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −8 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −7 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −6 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| −5 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| −4 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| −3 | K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 | 1 |
| −2 | K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020 | — |
| −1 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| 0 (this device) | K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 39 | 0 |
| 2005 | 27 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 45 | 1 |
| 2009 | 34 | 0 |
| 2010 | 23 | 0 |
| 2011 | 30 | 0 |
| 2012 | 18 | 0 |
| 2013 | 21 | 0 |
| 2014 | 17 | 0 |
| 2015 | 10 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K181115 | CxHA PEEK Cervical IBF SystemSummary page 5…888.3080 Product Code(s) OVE | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181115 CxHA PEEK Cervical IBF System ODP K162236 AxHA Stand-Alone ALIF System ovD K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IB… | 2018 |
| * | K162236 | Ax Stand-Alone ALIF SystemSummary page 5…arketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181115 CxHA PEEK Cervical IBF System ODP K162236 AxHA Stand-Alone ALIF System ovD K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System ODP K231899 HAtetracell-C Titaniu… | 2017 |
| * | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemSummary page 5…)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181115 CxHA PEEK Cervical IBF System ODP K162236 AxHA Stand-Alone ALIF System ovD K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System ODP K231899 HAtetracell-C Titanium Cervical IBF System ODP K210497 SeaSpin… | 2022 |
| * | K231899 | HAtetracell™-C Titanium Cervical IBF SystemSummary page 5…first) Product Code K181115 CxHA PEEK Cervical IBF System ODP K162236 AxHA Stand-Alone ALIF System ovD K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System ODP K231899 HAtetracell-C Titanium Cervical IBF System ODP K210497 SeaSpine Shoreline ACS - Anterior Cervical Standalone, OVE Device Descript… | 2023 |
| * | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…Summary page 5…em ODP K162236 AxHA Stand-Alone ALIF System ovD K220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF System ODP K231899 HAtetracell-C Titanium Cervical IBF System ODP K210497 SeaSpine Shoreline ACS - Anterior Cervical Standalone, OVE Device Description Summary 21 CFR 807.92(a)(4) The Endeavor™ Stand-Al… | 2021 |
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 1.0 years on median.
- 38 of the 404 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K181115.
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?
The Innovasis Endeavor TM Stand-Alone Cervical IBF System consists of a stand-alone interbody device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative…
Read the full statement (113 words)
The Innovasis Endeavor TM Stand-Alone Cervical IBF System consists of a stand-alone interbody device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The Endeavor device is intended to be used with the integrated fixation screws provided. The Endeavor device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
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/K250076 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250076: Endeavor™ Stand-Alone Cervical IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250076
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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