510(k) Report

510(k) · Cleared

Cleared

Stalif C

K120819510(k) SpecialCleared Aug 31, 2012165-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

Centinel Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Aug 31, 2012 as substantially equivalent to K072415 (Surgicraft, Ltd., 2008) and 3 other predicates after a 165-day review. Its family tree reaches back 11 generations to 1984. 206 later devices descend from it.

Decided
Aug 31, 2012
Review
165 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
4

Its longest line of descent runs back 11 generations to K841189 (1984). 43 ancestors in all. 206 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 3 other ancestors2007: 1 other ancestor2002: 5 other ancestors2009: 1 other ancestor2001: 9 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor2014: 2 descendants cleared2020: 12 descendants cleared2015: 5 descendants cleared2018: 6 descendants cleared2013: 2 descendants cleared2017: 2 descendants cleared2016: 3 descendants cleared2024: 35 descendants cleared2019: 8 descendants cleared2021: 13 descendants cleared2023: 28 descendants cleared2026: 33 descendants cleared2022: 21 descendants cleared2025: 36 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) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 8 other ancestors4 generations back: 5 other ancestors5 generations back: 5 other ancestors6 generations back: 6 other ancestors7 generations back: 2 other ancestors 1 generation forward: 11 descendants2 generations forward: 20 descendants3 generations forward: 21 descendants4 generations forward: 30 descendants5 generations forward: 18 descendants6 generations forward: 32 descendants7 generations forward: 39 descendants8 generations forward: 23 descendants9 generations forward: 10 descendants10 generations forward: 2 descendants K102606 · Avs Anchor-C Cervical Cage System · Stryker Spine · 2011 · recalledK091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 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+10
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  4. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  5. 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  6. This deviceK120819 Stalif CCentinel Spine, Inc. · 2012
  7. Descendant · cites it directly · 111 of its ownK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
  8. Descendant · 2 generations on · 110 of its ownK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
  9. Descendant · cites it directly · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  10. Descendant · 2 generations on · 106 of its ownK153122 Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015 · Recalled
  11. Descendant · 3 generations on · 105 of its ownK173535 Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, LLC · 2018 · Recalled
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. 1 generation backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
  12. This deviceK120819 Stalif CCentinel Spine, Inc. · 2012

Showing 5 of 206 descendants. See all descendants

Descendants cleared per year

2013: 22014: 22015: 52016: 32017: 22018: 62019: 82020: 122021: 132022: 212023: 282024: 352025: 362026: 33
2013high 36 (2025) · low 2 (2013)2026

Most influential descendants

Showing 5 of 206 · See all
  • K142940Endoskeleton TCS SystemTitan Spine, LLC · 2015 · cites it directly111descendants
  • K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · 2 generations on110descendants
  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · cites it directly108descendants
  • K153122Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015 · 2 generations on106descendants
  • K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC · 2018 · 3 generations on105descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−7K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−6K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−5K043479MC+ Partial VBRLdr Spine USA2005—
−4K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−3K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
−1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20111
0 (this device)K120819Stalif CCentinel Spine, Inc.2012—
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20152
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic…Titan Spine, LLC20182

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200190
200250
200340
200440
200520
200710
200830
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201420
201550
201630
201720
201860
201980
2020120
2021130
2022210
2023280
2024350
2025360
2026330
FIG. 1 — Lineage of K120819, 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? (4)

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
*K072415Stalif (TM) C
Summary page 2
…red from unalloyed Tantalum (ASTM F-560). Predicate Device: The subject STALIF C® intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K0724 15), Stryker Spine Anchor-C Cervical Cage System (K 102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages…
Surgicraft, Ltd.2008—
*K102606Avs Anchor-C Cervical Cage System
Summary page 2
…ice: The subject STALIF C® intervertebral body fusion device is substantially equivalent to predicate STALIF CTM (K0724 15), Stryker Spine Anchor-C Cervical Cage System (K 102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages (P000028), with respect to indications, design, ffincti…
Stryker Spine20111
*K071833Mosaic Devices
Summary page 2
…l body fusion device is substantially equivalent to predicate STALIF CTM (K0724 15), Stryker Spine Anchor-C Cervical Cage System (K 102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages (P000028), with respect to indications, design, ffinction, and materials. Substantial Equival…
Spinal Elements, Inc.2007—
*P000028Affinity (TM) Cage System
Summary page 2
…lent to predicate STALIF CTM (K0724 15), Stryker Spine Anchor-C Cervical Cage System (K 102606), Spinal Elements Mosaic Cage (K071833), and the Medtronic Affinity Cages (P000028), with respect to indications, design, ffinction, and materials. Substantial Equivalence: PEA simulation was performed on the wo…
Medtronic Sofamor Danek USA, Inc.2002—

Also cleared against K072415: 12 other devices →

What descends from it? (206)

See all 206

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

NumberDeviceApplicantDecidedDescendants
K142940Endoskeleton TCS SystemTitan Spine, LLC2015111
K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108
K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438
K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312
K133200Stalif C (R)Centinel Spine, Inc.201410
K181621Stable-C Interbody SystemNexus Spine, LLC20187
K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153
K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202
K192906Mecta-C Stand AloneMedacta International S.A.20201
K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170

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 28 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
  • 4 of the 43 ancestors have a recall of any class.
  • Of its descendants, K142940 (Titan Spine, LLC, 2015) has gone furthest, with 111 descendants of its own.
  • 12 other devices also cite its predicate K072415.

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. 2012, 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 STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to TI for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin wit degeneration of the disc confirmed by history and radiographic studies). The…

Read the full statement (121 words)

The STALIF C® is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to TI for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin wit degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIF CC is intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Indications for use as stated in the FDA summary.

Also cleared against K072415

12 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
  • K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2016
  • K142940Endoskeleton TCS SystemTitan Spine, LLC · 20152 recalls
  • K133494Chesapeake Spinal SystemK2m, Inc. · 2014

More from Centinel Spine, Inc.

10 FDA decisions under this applicant name. See the company

  • K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX…Centinel Spine, Inc. · 2018
  • K152211PCT SystemCentinel Spine, Inc. · 2015
  • K150053STALIF C; STALIF C-TiCentinel Spine, Inc. · 2015
  • K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
  • K141942Midline II TICentinel Spine, Inc. · 2014

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/K120819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120819: Stalif C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120819

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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