510(k) · Cleared
ClearedHive™ Stand-alone Anterior Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hd Lifesciences, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 28, 2020 as substantially equivalent to K170676 (Hd Lifesciences, LLC, 2017) and 3 other predicates after a 56-day review. Its family tree reaches back 21 generations to 1984. 1 of the 315 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 28, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K841189 (1984). 313 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 315 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- 1 generation backK182195 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- This deviceK200541 Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 2020
- Descendant · cites it directly · 0 of its ownK202820 Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK173082 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- 1 generation backK182195 Arco™-SA Lumbar Cage SystemNeurostructures, Inc. · 2018
- This deviceK200541 Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 2020
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K173082 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| −1 | K182195 | Arco™-SA Lumbar Cage System | Neurostructures, Inc. | 2018 | — |
| 0 (this device) | K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | 2020 | — |
| +1 | K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 8 | 0 |
| 2007 | 15 | 0 |
| 2008 | 42 | 1 |
| 2009 | 27 | 0 |
| 2010 | 22 | 0 |
| 2011 | 27 | 0 |
| 2012 | 15 | 0 |
| 2013 | 17 | 0 |
| 2014 | 19 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K170676 | HD Lumbar Interbody SystemSummary page 4…anel Division of Orthopedic Devices DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Hive™ Lumbar Interbody Fusion System is FDA cleared under K170676. This submission describes an addition to the Anterior IBFD configurations in which the device in combination with the provided s… | 2017 |
| * | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar SystemSummary page 5…or Proprietary or Model Name Manufacturer Predicate Type Number K170676 HDLS Lumbar Interbody System HD LifeSciences Primary K180814 M3 Stand-alone Anterior Lumbar System CoreLink Additional K180502 S128 ALIF System… | 2018 |
| * | K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) SystemSummary page 5…HDLS Lumbar Interbody System HD LifeSciences Primary K180814 M3 Stand-alone Anterior Lumbar System CoreLink Additional K180502 S128 ALIF System Renovis Additional K182195 Arco-SA Lumbar Cage System… | 2018 |
| * | K182195 | Arco™-SA Lumbar Cage SystemSummary page 5…M3 Stand-alone Anterior Lumbar System CoreLink Additional K180502 S128 ALIF System Renovis Additional K182195 Arco-SA Lumbar Cage System Neurostructures Additional PERFORMANCE DATA The Lumbar Interbody System… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202820 | Australis Anterior Lumbar Cage System | 2020 | 0 |
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 36 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 37 of the 313 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202820 (Prism Surgical Designs Pty, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K170676.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The HD LifeSciences Hive™ Stand-alone Anterior Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also…
Read the full statement (172 words)
The HD LifeSciences Hive™ Stand-alone Anterior Lumbar Interbody System is indicated for
use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two
contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the
disc confirmed by patient history and radiographic studies. Patients should have received 6
months of non-operative treatment prior to treatment with the devices. These DDD patients may
also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated
to be used with autograft bone and allograft bone comprised of cancellous and/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 stand-
alone interbody devices. If the accompanying screws are not used the device is intended for use
with supplemental fixation.
Hyperlordotic implants (20° and greater lordosis) must be used with supplemental fixation (e.g.
posterior fixation) that are cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200541: Hive™ Stand-alone Anterior Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200541
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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