510(k) · Cleared
ClearedHEDRON Cervical Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 17, 2019 as substantially equivalent to K173722 (Globus Medical, Inc., 2018) and 3 other predicates after a 131-day review. Its family tree reaches back 18 generations to 1984. 36 later devices descend from it.
- Decided
- Sep 17, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K841189 (1984). 243 ancestors in all, the oldest K792352 (1979). 36 later devices descend from it, 12 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 2 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 1 generation backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- This deviceK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · 2 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- Descendant · 2 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
- Descendant · 2 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 3 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 5 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 4 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 3 generations backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- 2 generations backK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- 1 generation backK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- This deviceK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · cites it directly23descendants
- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 2 generations on6descendants
- K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 2 generations on5descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 2 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −5 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −4 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −3 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| −1 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +2 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| +2 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | — |
| +2 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +3 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 13 | 0 |
| 2008 | 27 | 0 |
| 2009 | 18 | 0 |
| 2010 | 10 | 0 |
| 2011 | 13 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 11 | 0 |
| 2026 | 12 | 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 ODP? 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? (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 |
|---|---|---|---|
| * | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN SpacerSummary page 4…Body Fusion Device Product Code(s): ODP, OVE Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL Spacers (K173722) Other Predicates: COALITION AGX® (K142218, K173115) REVEL™ Spacers (K180909) Reference Device: NeoF… | 2018 |
| * | K142218 | Coalition AGX Plate and Coalition AGX SpacerSummary page 4…uct Code(s): ODP, OVE Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL Spacers (K173722) Other Predicates: COALITION AGX® (K142218, K173115) REVEL™ Spacers (K180909) Reference Device: NeoFuse Ti3D Cervical Interbody (K170318) Purpo… | 2015 |
| * | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Summary page 4…s): ODP, OVE Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL Spacers (K173722) Other Predicates: COALITION AGX® (K142218, K173115) REVEL™ Spacers (K180909) Reference Device: NeoFuse Ti3D Cervical Interbody (K170318) Purpose: The p… | 2017 |
| * | K180909 | REVEL SpacersSummary page 4…Class: II, Panel Code: 87 Primary Predicate: PATRIOT® COLONIAL Spacers (K173722) Other Predicates: COALITION AGX® (K142218, K173115) REVEL™ Spacers (K180909) Reference Device: NeoFuse Ti3D Cervical Interbody (K170318) Purpose: The purpose of this submission is to request cle… | 2018 |
| † | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | 2017 |
What descends from it? (36)
See all 3612 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 | 23 |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | 2020 | 3 |
| K250540 | SABER-C System | 2025 | 2 |
| K260660 | SABER-C System | 2026 | 1 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | 2025 | 1 |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | 2026 | 0 |
| K253260 | ORIO-3D Cage System | 2026 | 0 |
| K250764 | SpineLinc Anterior Cervical Implant System | 2025 | 0 |
| K250769 | Dakota LP System | 2025 | 0 |
| K250335 | IVA & AEON Cervical and Lumbar Cage System | 2025 | 0 |
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 1.0 years on median.
- 26 of the 243 ancestors have a recall of any class.
- Of its descendants, K222270 (Globus Medical, Inc., 2022) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K173722.
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. 2019, 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?
HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or…
Read the full statement (232 words)
HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191243: HEDRON Cervical Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191243
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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