510(k) · Cleared
ClearedNuVasive® Interfixated Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 20, 2016 as substantially equivalent to K140479 (Nu Vasive, Incorporated, 2014) and 4 other predicates after a 100-day review. Its family tree reaches back 17 generations to 1984. 396 later devices descend from it.
- Decided
- Apr 20, 2016
- Review
- 100 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 177 ancestors in all. 396 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- 1 generation backK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- This deviceK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 304 of its ownK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 4 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- 1 generation backK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- This deviceK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Showing 5 of 396 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 396 · See all- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly381descendants
- K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017 · 2 generations on304descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on251descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on227descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −4 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −2 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| −1 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +2 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
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 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 25 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 19 | 0 |
| 2020 | 33 | 0 |
| 2021 | 36 | 0 |
| 2022 | 49 | 0 |
| 2023 | 54 | 0 |
| 2024 | 73 | 0 |
| 2025 | 57 | 0 |
| 2026 | 46 | 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 OVD? 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 |
|---|---|---|---|
| * | K140479 | Coroent XL-F SystemSummary page 4…OVD C. Predicate Devices The subject NuVasive Interfixated Interbody System is substantially equivalent to primary predicate NuVasive CoRoent XL-F System (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brig… | 2014 |
| * | K131723 | Coroent Single Tab SystemSummary page 4…y System is substantially equivalent to primary predicate NuVasive CoRoent XL-F System (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419… | 2013 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 4…rimary predicate NuVasive CoRoent XL-F System (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419). D. Device Description The sub… | 2010 |
| * | K123045 | Brigade Standalone SystemSummary page 4…ystem (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419). D. Device Description The subject NuVasive Interfixated Interbody System a… | 2013 |
| * | K153419 | NuVasive CoRoent Thoracolumbar System Cleared while this submission was under review Summary page 4…uVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419). D. Device Description The subject NuVasive Interfixated Interbody System are interbodies manufactured from PEEK-O… | 2016 |
What descends from it? (396)
See all 3962 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 19 of the 177 ancestors have a recall of any class.
- Of its descendants, K161230 (Nu Vasive, Incorporated, 2016) has gone furthest, with 381 descendants of its own.
- 7 other devices also cite its predicate K140479.
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. 2016, 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 NuVasive® Interfixated Interbody System is indicated for the following: CoRoent XL-F System The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated…
Read the full statement (395 words)
The NuVasive® Interfixated Interbody System is indicated for the following:
CoRoent XL-F System
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Brigade System
The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
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/K160051 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160051: NuVasive® Interfixated Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160051
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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