510(k) · Cleared
ClearedALIF Interfixated 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 Jun 25, 2015 as substantially equivalent to K123045 (Nuvasive, Inc., 2013) and 5 other predicates after a 50-day review. Its family tree reaches back 16 generations to 1984. 220 later devices descend from it.
- Decided
- Jun 25, 2015
- Review
- 50 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K841189 (1984). 98 ancestors in all. 220 later devices descend from it, 7 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
- This deviceK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 187 of its ownK152943 NuVasive Foundation-LL SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 186 of its ownK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 157 of its ownK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- Descendant · 2 generations on · 156 of its ownK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- Descendant · 2 generations on · 94 of its ownK203201 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2021
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 3 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 2 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 1 generation backK141942 Midline II TICentinel Spine, Inc. · 2014
- This deviceK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
Showing 5 of 220 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 220 · See all- K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated · 2015 · cites it directly187descendants
- K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017 · cites it directly186descendants
- K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020 · 2 generations on157descendants
- K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2020 · 2 generations on156descendants
- K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated · 2021 · 2 generations on94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −3 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −2 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −1 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| 0 (this device) | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K152943 | NuVasive Foundation-LL System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| +2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| +2 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 17 | 0 |
| 2022 | 21 | 0 |
| 2023 | 32 | 0 |
| 2024 | 53 | 0 |
| 2025 | 40 | 0 |
| 2026 | 31 | 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? (6)
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 |
|---|---|---|---|
| * | K123045 | Brigade Standalone SystemSummary page 4…VD C. Predicate Devices The subject NuVasive ALIF Interfixated System is substantially equivalent to the following devices: Primary Predicate K123045 – NuVasive Brigade® Hyperlordotic System Additional Predicates K100043 – NuVasive CoRoent® XLR Standalone System… | 2013 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 4…tantially equivalent to the following devices: Primary Predicate K123045 – NuVasive Brigade® Hyperlordotic System Additional Predicates K100043 – NuVasive CoRoent® XLR Standalone System K120918 – NuVasive CoRoent® Titanium System K071795 – NuVasive CoRoent®… | 2010 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 4…Primary Predicate K123045 – NuVasive Brigade® Hyperlordotic System Additional Predicates K100043 – NuVasive CoRoent® XLR Standalone System K120918 – NuVasive CoRoent® Titanium System K071795 – NuVasive CoRoent® System K073109 – SurgicraftTM Limited STALIF® TT… | 2012 |
| * | K071795 | Nuvasive Coroent SystemSummary page 4…e® Hyperlordotic System Additional Predicates K100043 – NuVasive CoRoent® XLR Standalone System K120918 – NuVasive CoRoent® Titanium System K071795 – NuVasive CoRoent® System K073109 – SurgicraftTM Limited STALIF® TT Intervertebral Body Fusion System K141942 –… | 2007 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 4…edicates K100043 – NuVasive CoRoent® XLR Standalone System K120918 – NuVasive CoRoent® Titanium System K071795 – NuVasive CoRoent® System K073109 – SurgicraftTM Limited STALIF® TT Intervertebral Body Fusion System K141942 – Centinel SpineTM Midline IITM / Midline II-… | 2008 |
| * | K141942 | Midline II TISummary page 4…NuVasive CoRoent® Titanium System K071795 – NuVasive CoRoent® System K073109 – SurgicraftTM Limited STALIF® TT Intervertebral Body Fusion System K141942 – Centinel SpineTM Midline IITM / Midline II-TiTM D. Device Description The NuVasive ALIF Interfixated System is an inter… | 2014 |
What descends from it? (220)
See all 2207 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152943 | NuVasive Foundation-LL System | 2015 | 187 |
| K170592 | NuVasive BASE Interfixated Titanium System | 2017 | 186 |
| K163595 | IMPIX 3D Print Cages | 2017 | 28 |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | 2018 | 18 |
| K192026 | Peridot Intervertebral body fusion System | 2019 | 6 |
| K180963 | Roccia Alif, Roccia Tlif | 2018 | 3 |
| K180695 | FBC 921 (Alif) | 2018 | 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 31 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 16 of the 98 ancestors have a recall of any class.
- Of its descendants, K152943 (Nu Vasive, Incorporated, 2015) has gone furthest, with 187 descendants of its own.
- 16 other devices also cite its predicate K123045.
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. 2015, 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 ALIF Interfixated System is 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…
Read the full statement (170 words)
The ALIF Interfixated System is 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 ALIF Interfixated System is intended for use with autograft.
The ALIF Interfixated System 10° — 20° lordotic cages may be used as a standalone system. The ALIF Interfixated System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the ALIF Interfixated System.
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/K151214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151214: ALIF Interfixated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151214
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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