510(k) · Cleared
ClearedHive™ Standalone Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NanoHive Medical, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 12, 2022 as substantially equivalent to K212904 (SeaSpine Orthopedics Corporation, 2021) and 2 other predicates after a 60-day review. Its family tree reaches back 27 generations to 1984. 1 of the 614 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Dec 12, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 27 generations to K841189 (1984). 608 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 2 citing it directly. 1 of the 614 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
- Descendant · cites it directly · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254105 Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 2026
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 9 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 8 generations backK160955 Tritanium® PL CageStryker · 2016
- 7 generations backK162262 Tritanium® PL CageStryker · 2016
- 6 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 5 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 4 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 3 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · cites it directly3descendants
- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · 2 generations on2descendants
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 3 generations on1descendant
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 3 generations on0descendants
- K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −9 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −8 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −7 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −6 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −5 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −2 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| 0 (this device) | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | — |
| +1 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +2 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| +3 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +3 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | — |
| +1 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 20 | 0 |
| 2004 | 30 | 0 |
| 2005 | 25 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 55 | 1 |
| 2009 | 43 | 0 |
| 2010 | 33 | 0 |
| 2011 | 52 | 0 |
| 2012 | 36 | 0 |
| 2013 | 33 | 0 |
| 2014 | 44 | 0 |
| 2015 | 33 | 0 |
| 2016 | 30 | 0 |
| 2017 | 27 | 0 |
| 2018 | 8 | 0 |
| 2019 | 8 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K212904 | SeaSpine WaveForm C Interbody SystemSummary page 5…odel Name Manufacturer Product Code Predicate Number Type K212904 SeaSpine WaveForm™ C Interbody System SeaSpine Orthopedics OVE, ODP Primary… | 2021 |
| * | K212853 | Cervical Stand-Alone SystemSummary page 5…K212904 SeaSpine WaveForm™ C Interbody System SeaSpine Orthopedics OVE, ODP Primary Corporation K212853 Cervical Stand-Alone System Eminent Spine, LLC OVE Additional K190885 Elevation Spine Sab… | 2021 |
| * | K190885 | Elevation Spine Saber-C SystemSummary page 5…Corporation K212853 Cervical Stand-Alone System Eminent Spine, LLC OVE Additional K190885 Elevation Spine Saber-C System Elevation Spine OVE, ODP, KWQ Additional K200541 Hive™ Stand-alone A… | 2019 |
| † | K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | 2020 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 66 of the 608 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242260 (Carlsmed, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K212904.
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. 2022, 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 Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone…
Read the full statement (153 words)
The Hive™ Standalone Cervical System with NanoHive® Surface Technology is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous or corticocancellous bone. These devices are intended to be used with the screws which accompany the implants. When used with the accompanying screws, these devices may be used as standalone interbody devices. If the accompanying screws are not used, the device is intended for use with supplemental fixation. When used as a standalone system, the Hive™ Standalone Cervical System is intended for use at one or two levels (C2-T1) and must be used with the provided bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223190: Hive™ Standalone Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223190
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