510(k) · Cleared
ClearedCoroent XLR Standalone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jun 16, 2010 as substantially equivalent to K073109 (Surgicraft, Ltd., 2008) and 4 other predicates after a 159-day review. Its family tree reaches back 12 generations to 1984. 1 of the 809 devices in its family, counting itself, has a Class I recall. 744 later devices descend from it.
- Decided
- Jun 16, 2010
- Review
- 159 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 64 ancestors in all. 744 later devices descend from it, 11 citing it directly. 1 of the 809 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · cites it directly · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
Showing 5 of 744 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 744 · See all- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · cites it directly696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · 2 generations on465descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · 2 generations on459descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| 0 (this device) | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +1 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 16 | 0 |
| 2016 | 36 | 0 |
| 2017 | 43 | 0 |
| 2018 | 52 | 0 |
| 2019 | 63 | 0 |
| 2020 | 82 | 0 |
| 2021 | 67 | 1 |
| 2022 | 68 | 0 |
| 2023 | 79 | 0 |
| 2024 | 87 | 0 |
| 2025 | 76 | 0 |
| 2026 | 62 | 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? (5)
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 |
|---|---|---|---|
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…icate Devices The subject CoRoent® XLR Standalone System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: K073109 - SurgiCraft STALIF™ TT System KO081849 - Blackstone Medical PILLAR™ SA PEEK Spacer System K072253 — Synthes SynFix™-LR K081501… | 2008 |
| * | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement DeviceSummary page 1…andalone System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: K073109 - SurgiCraft STALIF™ TT System KO081849 - Blackstone Medical PILLAR™ SA PEEK Spacer System K072253 — Synthes SynFix™-LR K081501 — Biomet Spine Solitaire™ Anterior Spina… | 2008 |
| * | K072253 | Synfix-LR SpacerSummary page 1…ng predicate devices currently distributed commercially in the U.S.: K073109 - SurgiCraft STALIF™ TT System KO081849 - Blackstone Medical PILLAR™ SA PEEK Spacer System K072253 — Synthes SynFix™-LR K081501 — Biomet Spine Solitaire™ Anterior Spinal System K083475 - Spinal Elements Lucent® Magnum-+ Device… | 2007 |
| * | K081501 | Solitaire Anterior Spinal SystemSummary page 1…distributed commercially in the U.S.: K073109 - SurgiCraft STALIF™ TT System KO081849 - Blackstone Medical PILLAR™ SA PEEK Spacer System K072253 — Synthes SynFix™-LR K081501 — Biomet Spine Solitaire™ Anterior Spinal System K083475 - Spinal Elements Lucent® Magnum-+ Device Description The NuVasive CoR… | 2008 |
| * | K083475 | Lucent MagnumSummary page 1…aft STALIF™ TT System KO081849 - Blackstone Medical PILLAR™ SA PEEK Spacer System K072253 — Synthes SynFix™-LR K081501 — Biomet Spine Solitaire™ Anterior Spinal System K083475 - Spinal Elements Lucent® Magnum-+ Device Description The NuVasive CoRoent XLR-Standalone System is an implantable device manuf… | 2009 |
What descends from it? (744)
See all 74411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123045 | Brigade Standalone System | 2013 | 696 |
| K160051 | NuVasive® Interfixated Interbody System | 2016 | 396 |
| K153782 | NuVasive® Lumbar Interbody Implants | 2016 | 390 |
| K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | 2015 | 228 |
| K151214 | ALIF Interfixated System | 2015 | 220 |
| K181386 | NuVasive Brigade Lateral System | 2018 | 158 |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | 2020 | 141 |
| K102547 | Coroent Interlock System | 2011 | 131 |
| K151665 | SUSTAIN Additional Implants | 2016 | 119 |
| K111166 | A-Wedge Anterior Interbody System (a-Wedge a.I.S.) | 2011 | 23 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 64 ancestors have a recall of any class.
- Of its descendants, K123045 (Nuvasive, Inc., 2013) has gone furthest, with 696 descendants of its own.
- 31 other devices also cite its predicate K073109.
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. 2010, 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?
When used as an intervertebral body fusion device: The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1…
Read the full statement (219 words)
When used as an intervertebral body fusion device:
The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.
When used as a partial Vertebral Body Replacement (VBR):
The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.
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/K100043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100043: Coroent XLR Standalone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100043
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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