510(k) Report

510(k) · Cleared

Cleared

Vault-C Intervertebral Body Fusion Device

K132029510(k) TraditionalCleared Nov 25, 2013147-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spinal USA · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Nov 25, 2013 as substantially equivalent to K120819 (Centinel Spine, Inc., 2012) and 5 other predicates after a 147-day review. Its family tree reaches back 14 generations to 1984. 108 later devices descend from it.

Decided
Nov 25, 2013
Review
147 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
6

Its longest line of descent runs back 14 generations to K841189 (1984). 100 ancestors in all. 108 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors2011: 2 other ancestors2009: 7 other ancestors2010: 2 other ancestors2008: 14 other ancestors2007: 6 other ancestors2005: 4 other ancestors2002: 9 other ancestors2001: 11 other ancestors2006: 2 other ancestors2004: 8 other ancestors2003: 7 other ancestors1999: 1 other ancestor1996: 6 other ancestors2000: 2 other ancestors1990: 1 other ancestor1992: 2 other ancestors2024: 19 descendants cleared2019: 2 descendants cleared2021: 5 descendants cleared2020: 5 descendants cleared2026: 21 descendants cleared2023: 18 descendants cleared2022: 13 descendants cleared2025: 25 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K080401 · Shell Cage, Wave Cage, Loop Cage · Advanced Medical Technologies AG · 2008K082801 · Phantom Plus Cage System · Us Spine · 2008K093093 · Small Plateau Spacer System · Life Spine · 2010K111835 · Plateau Spacer System · Life Spine, Inc. · 2011K121151 · Pro-Link Cervical Spacer System · Life Spine, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 14 other ancestors3 generations back: 20 other ancestors4 generations back: 25 other ancestors5 generations back: 13 other ancestors6 generations back: 6 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 20 descendants4 generations forward: 7 descendants5 generations forward: 13 descendants6 generations forward: 21 descendants7 generations forward: 18 descendants8 generations forward: 9 descendants9 generations forward: 1 descendant K121151 · Pro-Link Cervical Spacer System · Life Spine, Inc. · 2012K111835 · Plateau Spacer System · Life Spine, Inc. · 2011K093093 · Small Plateau Spacer System · Life Spine · 2010K082801 · Phantom Plus Cage System · Us Spine · 2008K080401 · Shell Cage, Wave Cage, Loop Cage · Advanced Medical Technologies AG · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
  4. 2 generations backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
  5. 1 generation backK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
  6. This deviceK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  7. Descendant · cites it directly · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  8. Descendant · 2 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
  9. Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
  10. Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  11. Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 5 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
  11. 4 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
  12. 3 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
  13. 2 generations backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
  14. 1 generation backK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
  15. This deviceK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2019: 22020: 52021: 52022: 132023: 182024: 192025: 252026: 21
2019high 25 (2025) · low 2 (2019)2026

Most influential descendants

Showing 5 of 108 · See all
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · cites it directly93descendants
  • K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 2 generations on72descendants
  • K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−6K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−5K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008—
−4K082801Phantom Plus Cage SystemUs Spine2008—
−3K093093Small Plateau Spacer SystemLife Spine2010—
−2K111835Plateau Spacer SystemLife Spine, Inc.2011—
−1K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012—
0 (this device)K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC2020—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.2020—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199220
199660
199910
200020
2001110
200290
200370
200480
200540
200620
200760
2008140
200970
201020
201120
201220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202050
202150
2022130
2023180
2024190
2025250
2026210
FIG. 1 — Lineage of K132029, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OVE? 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K120819Stalif C
Our reading of the summary gave K121819, FDA’s number for Surgiclear Antimicrobial Clear Silicone Adhesive Dressing… (Covalontechnologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Centinel Spine Stalif C System”.
Centinel Spine, Inc.2012—
*K113796Solitaire-C Cervical Spacer System
Summary page 1
…s Panel Predicate Devices: ICentinel Spine Stalif C System (K 1218 19) Riomet Spine. Solitaire-C System (KI 113796) I L-DR Spine ROI-C (K091088. KI 113559) ILifle…
Ebi, LLC20121
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 1
…f C System (K 1218 19) Riomet Spine. Solitaire-C System (KI 113796) I L-DR Spine ROI-C (K091088. KI 113559) ILifle Spine, Inc. Pro-Link Stand-Alone Cervical System…
Ldr Spine USA2009—
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 1
…K 1218 19) Riomet Spine. Solitaire-C System (KI 113796) I L-DR Spine ROI-C (K091088. KI 113559) ILifle Spine, Inc. Pro-Link Stand-Alone Cervical System…
Ldr Spine USA, Inc.2011—
*K121151Pro-Link Cervical Spacer System
Summary page 1
…ine ROI-C (K091088. KI 113559) ILifle Spine, Inc. Pro-Link Stand-Alone Cervical System (K 121151) 1 Globus Medical. Inc COALITION Spacer (K08 3389) DESCRIPTION OF THE DEVICE SUBJECT…
Life Spine, Inc.2012—
*K083389Coalition Spacer
Summary page 1
…. Pro-Link Stand-Alone Cervical System (K 121151) 1 Globus Medical. Inc COALITION Spacer (K08 3389) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Vault-C consists of a spacer assembly including a PEEK…
Globus Medical, Inc.2009—

Also cleared against K120819: 10 other devices →

What descends from it? (108)

See all 108

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993
K212853Cervical Stand-Alone SystemEminent Spine, LLC202118
K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910
K212562Idys-C ZP 3DTiClariance, SA20211
K240715Idys® C ZP 3DTiClariance20240
K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210

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 29 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
  • 15 of the 100 ancestors have a recall of any class.
  • Of its descendants, K190546 (Nexxt Spine, LLC, 2019) has gone furthest, with 93 descendants of its own.
  • 10 other devices also cite its predicate K120819.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The Vault-C Standalone Cervical Interbody Fusion System is astandalone cervical interbody

device intended for use in skeletally mature patients with degenerative disc disease (ODD) of' the

cervical spine (C3-T I) at one disc level. ODD is defined as discogenic pain with degeneration of the

disc confirmed by history and radiographic studies. The Vault-C implants are used with two

titanium alloy screws and filled with aucogenous bone graft material to facilitate fusion in the

cervical spine. The device is placed via an anterior approach at the C-3 to T-I disc levels.

Patients should have at least six weeks of non-operative treatment prior to treatment with an

intervertebral fusion device

Indications for use as stated in the FDA summary.

Also cleared against K120819

10 other devices cite the same predicate.

  • K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
  • K192906Mecta-C Stand AloneMedacta International S.A. · 2020
  • K181621Stable-C Interbody SystemNexus Spine, LLC · 2018
  • K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc. · 2017
  • K162531Sterispine CCSafe Orthopaedics · 2016
  • K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2015

More from Spinal USA

23 FDA decisions under this applicant name. See the company

  • K130863Facet Screw SystemSpinal USA · 2013
  • K131343Reform Pedicle Screw SystemSpinal USA · 2013
  • K130279Reform Pedicle Screw SystemSpinal USA · 2013
  • K130445Vault Alif SystemSpinal USA · 2013
  • K122931S-Lok PSS SystemSpinal USA · 2012

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K132029 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132029: Vault-C Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132029

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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