510(k) · Cleared
ClearedHive™ Standalone Cervical System and Hive™ C Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NanoHive Medical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Feb 13, 2026 as substantially equivalent to K223190 (NanoHive Medical, LLC, 2022) and 6 other predicates after a 56-day review. Its family tree reaches back 33 generations to 1984. 4 of the 1,437 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 13, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 33 generations to K841189 (1984). 1,436 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 4 of the 1,437 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- 1 generation backK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- This deviceK254105 Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 2026
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 15 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 14 generations backK160955 Tritanium® PL CageStryker · 2016
- 13 generations backK162262 Tritanium® PL CageStryker · 2016
- 12 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 11 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 10 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 7 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 6 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 5 generations backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- 4 generations backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- 3 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- 1 generation backK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- This deviceK254105 Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −15 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −14 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −11 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −10 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −9 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −8 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −7 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −6 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| −5 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| −4 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | — |
| −3 | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | — |
| −2 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | — |
| −1 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral… | SeaSpine Orthopedics Corporation | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 3 | 0 |
| 1988 | 3 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 12 | 0 |
| 1993 | 10 | 0 |
| 1994 | 17 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 23 | 0 |
| 1998 | 40 | 0 |
| 1999 | 31 | 0 |
| 2000 | 45 | 0 |
| 2001 | 55 | 0 |
| 2002 | 52 | 0 |
| 2003 | 60 | 0 |
| 2004 | 82 | 0 |
| 2005 | 68 | 0 |
| 2006 | 53 | 0 |
| 2007 | 50 | 0 |
| 2008 | 97 | 1 |
| 2009 | 69 | 0 |
| 2010 | 62 | 1 |
| 2011 | 82 | 0 |
| 2012 | 51 | 0 |
| 2013 | 55 | 0 |
| 2014 | 61 | 0 |
| 2015 | 55 | 1 |
| 2016 | 49 | 1 |
| 2017 | 45 | 0 |
| 2018 | 22 | 0 |
| 2019 | 19 | 0 |
| 2020 | 22 | 0 |
| 2021 | 14 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 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.
4 devices in this family have 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K223190 | Hive™ Standalone Cervical SystemSummary page 5…ages made from Ti-6Al-4V per ASTM F3001 and screws, plates, and anchors made from Ti-6Al-4V per ASTM F136. The cages, bone screws, and plates were originally cleared via K223190. The purpose of this submission is to add bone anchors as an additional form of internal fixation and include an additional packa… | 2022 |
| * | K241846 | E3D™-C Interbody SystemSummary page 6…Manufacturer Product Code Predicate Type K223190 Hive™ Standalone Cervical System NanoHive Medical LLC OVE, ODP Primary K241846 E3D™-C Interbody System Evolution Spine OVE, ODP Additional The subject device is di… | 2024 |
| * | K180364 | HD LifeSciences Cervical IBFD SystemSummary page 7…ces. Predicate Devices – Hive™ C Interbody System 510k Number Trade or Proprietary Name Manufacturer Predicate Type K180364 HD LifeSciences Cervical IBFD HD LifeSciences LLC Primary K212904/K213359/K241466 Wa… | 2018 |
| * | K212904 | SeaSpine WaveForm C Interbody SystemSummary page 7…Manufacturer Predicate Type K180364 HD LifeSciences Cervical IBFD HD LifeSciences LLC Primary K212904/K213359/K241466 WaveForm C Interbody System SeaSpine Orthopedics Corporation Additional K240838… | 2021 |
| * | K213359 | SeaSpine WaveForm, C Interbody SystemSummary page 7…Manufacturer Predicate Type K180364 HD LifeSciences Cervical IBFD HD LifeSciences LLC Primary K212904/K213359/K241466 WaveForm C Interbody System SeaSpine Orthopedics Corporation Additional K240838 Spe… | 2021 |
| * | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…Summary page 7…urer Predicate Type K180364 HD LifeSciences Cervical IBFD HD LifeSciences LLC Primary K212904/K213359/K241466 WaveForm C Interbody System SeaSpine Orthopedics Corporation Additional K240838 Spectrum Sp… | 2024 |
| * | K240838 | Spectrum Spine Cervical Cage SystemSummary page 7…FD HD LifeSciences LLC Primary K212904/K213359/K241466 WaveForm C Interbody System SeaSpine Orthopedics Corporation Additional K240838 Spectrum Spine Cervical Cage System Spectrum Spine, Inc. Additional There are no differenc… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 17 companies; a new generation was cleared every 8 months on median.
- 162 of the 1,436 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K223190.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Hive™ Standalone Cervical System, including devices with a microscopic roughened surface and micro and nano-scale features, is indicated at one or more levels of the cervical spine (C2-T1) in skeletally mature patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. DDD is defined…
Read the full statement (307 words)
The Hive™ Standalone Cervical System, including devices with a microscopic roughened surface and micro and nano-scale features, is indicated at one or more levels of the cervical spine (C2-T1) in skeletally mature patients with cervical degenerative disc disease (DDD), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autogra:ft bone and/or allogra:ft bone comprised of cancellous, cortical, and/or corticocancellous bone.
The Hive™ Standalone Cervical System is intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When used with anchors, or without two screws, these devices are intended to be used with supplemental fixation ( e.g. cervical plates or cervical posterior fixation).
The Hive™ C Interbody System, including devices with a microscopic roughened surface and micro and nano-scale features, is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to Tl. Patients should have received at least six (6) weeks of non-operative treatment prior to treatment with an interbody fusion device. The Hive™ C Interbody System is indicated to be used with autograft bone and/or allograft bone comprised of cancellous, cortical, and/or corticocancellous bone and/or demineralized allogra:ft bone with bone marrow aspirate to facilitate fusion (hereafter referred to as bone graft). The Hive™ C Interbody System requires additional supplemental fixation cleared for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254105: Hive™ Standalone Cervical System and Hive™ C Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254105
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