510(k) · Cleared
ClearedHEDRON Lumbar Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 18, 2019 as substantially equivalent to K170157 (Globus Medical, Inc., 2017) and 3 other predicates after a 117-day review. Its family tree reaches back 21 generations to 1984. 84 later devices descend from it.
- Decided
- Sep 18, 2019
- Review
- 117 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K841189 (1984). 292 ancestors in all, the oldest K792352 (1979). 84 later devices descend from it, 19 citing it directly.
- 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 backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- This deviceK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 36 of its ownK201087 CORBEL SpacersGlobus Medical, Inc. · 2020
- Descendant · cites it directly · 35 of its ownK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- Descendant · cites it directly · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- Descendant · cites it directly · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · cites it directly · 17 of its ownK202034 aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 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 backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- This deviceK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K201087CORBEL SpacersGlobus Medical, Inc. · 2020 · cites it directly36descendants
- K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc. · 2021 · cites it directly35descendants
- K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · cites it directly25descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · cites it directly23descendants
- K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 2020 · cites it directly17descendants
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 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | — |
| +1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| +1 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
| +1 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +1 | K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 15 | 0 |
| 2008 | 36 | 0 |
| 2009 | 22 | 0 |
| 2010 | 18 | 0 |
| 2011 | 18 | 0 |
| 2012 | 15 | 0 |
| 2013 | 18 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 11 | 0 |
| 2024 | 27 | 0 |
| 2025 | 16 | 0 |
| 2026 | 14 | 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.
Planning a device in MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K170157 | INDEPENDENCE® SpacersSummary page 4…Body Fusion Device Product Code(s): MAX, OVD, PHM Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K170157) Other Predicates: INDEPENDENCE® Spacers (K160597) PATRIOT® Spacers (K181357) SUSTAIN® Space… | 2017 |
| * | K160597 | INDEPENDENCE MIS SpacersSummary page 4…(s): MAX, OVD, PHM Regulatory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K170157) Other Predicates: INDEPENDENCE® Spacers (K160597) PATRIOT® Spacers (K181357) SUSTAIN® Spacers (K181357) CALIBER® Spacers (K1… | 2016 |
| * | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® SpacersSummary page 4…tory Class: II, Panel Code: 87 Primary Predicate: INDEPENDENCE® Spacers (K170157) Other Predicates: INDEPENDENCE® Spacers (K160597) PATRIOT® Spacers (K181357) SUSTAIN® Spacers (K181357) CALIBER® Spacers (K102293) Reference Device: NeoFuse Ti3D Interb… | 2018 |
| * | K102293 | Caliber SpacerSummary page 4…Predicates: INDEPENDENCE® Spacers (K160597) PATRIOT® Spacers (K181357) SUSTAIN® Spacers (K181357) CALIBER® Spacers (K102293) Reference Device: NeoFuse Ti3D Interbody (K170318) ANTHEM® Fracture System (K163361) Purpose: The purpose of… | 2011 |
| † | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | 2017 |
| † | K163361 | ANTHEM™ Fracture System | 2017 |
What descends from it? (84)
See all 8419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201087 | CORBEL Spacers | 2020 | 36 |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental… | 2021 | 35 |
| K201671 | A-Link Z | 2021 | 25 |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 | 23 |
| K202034 | aprevo Intervertebral Body Fusion Device | 2020 | 17 |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | 2022 | 12 |
| K213935 | PISCES-SA Standalone ALIF Interbody System | 2022 | 12 |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal… | 2022 | 11 |
| K223146 | EVOLUTION SPINE Interbody System | 2023 | 9 |
| K240368 | E3D™-A Interbody System | 2024 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 30 of the 292 ancestors have a recall of any class.
- Of its descendants, K201087 (Globus Medical, Inc., 2020) has gone furthest, with 36 descendants of its own.
- 5 other devices also cite its predicate K170157.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
HEDRON™ Lumbar Spacers (HEDRON A™, HEDRON L™, HEDRON P™ HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or…
Read the full statement (365 words)
HEDRON™ Lumbar Spacers (HEDRON A™, HEDRON L™, HEDRON P™ HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. HEDRON™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
HEDRON TA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). HEDRON IA™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
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/K191391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191391: HEDRON Lumbar Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191391
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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