510(k) · Cleared
ClearedVault Alif System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 4, 2011 as substantially equivalent to K092193 (Spinal USA, 2009) and 2 other predicates after a 138-day review. Its family tree reaches back 11 generations to 1984. 10 later devices descend from it.
- Decided
- Apr 4, 2011
- Review
- 138 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 44 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK103369 Vault Alif SystemSpinal USA · 2011
- Descendant · cites it directly · 9 of its ownK130445 Vault Alif SystemSpinal USA · 2013
- Descendant · cites it directly · 5 of its ownK132596 Proposed OptimusCustom Spine, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK200352 Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253559 Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213118 Dakota ALIF SystemPrecision Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK103369 Vault Alif SystemSpinal USA · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130445Vault Alif SystemSpinal USA · 2013 · cites it directly9descendants
- K132596Proposed OptimusCustom Spine, Inc. · 2014 · cites it directly5descendants
- K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd. · 2020 · 2 generations on2descendants
- K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. · 2026 · 2 generations on0descendants
- K213118Dakota ALIF SystemPrecision Spine, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| 0 (this device) | K103369 | Vault Alif System | Spinal USA | 2011 | — |
| +1 | K130445 | Vault Alif System | Spinal USA | 2013 | — |
| +1 | K132596 | Proposed Optimus | Custom Spine, Inc. | 2014 | 1 |
| +2 | K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | 2020 | — |
| +2 | K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026 | — |
| +1 | K213118 | Dakota ALIF System | Precision Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K092193 | Spinal Usa Interbody CagesSummary page 2…is based upon cquivalence in intended use, indications, anatomic sites, performance and material of manufacture. Predicate Devices: Spinal USA Interbody Fusion Device (K092193) Solitare Anterior Spinal System (K081501) STALIF TT Intervertebral Body Fusion System (K073109) F-2 WIALTH 4… | 2009 |
| * | K081501 | Solitaire Anterior Spinal SystemSummary page 2…indications, anatomic sites, performance and material of manufacture. Predicate Devices: Spinal USA Interbody Fusion Device (K092193) Solitare Anterior Spinal System (K081501) STALIF TT Intervertebral Body Fusion System (K073109) F-2 WIALTH 4 ot %, DEPARTMENT OF HEALTH & HUMAN SERVICE… | 2008 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 2…f manufacture. Predicate Devices: Spinal USA Interbody Fusion Device (K092193) Solitare Anterior Spinal System (K081501) STALIF TT Intervertebral Body Fusion System (K073109) F-2 WIALTH 4 ot %, DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration… | 2008 |
What descends from it? (10)
3 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 27 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K130445 (Spinal USA, 2013) has gone furthest, with 9 descendants of its own.
- 10 other devices also cite its predicate K092193.
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. 2011, 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 Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined…
Read the full statement (147 words)
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative trecatment prior to treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
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/K103369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103369: Vault Alif System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103369
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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