510(k) Report

510(k) · Cleared

Cleared

TirboLOX-C Cervical IBFD

K181229510(k) TraditionalCleared Sep 19, 2018133-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

Captiva Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Sep 19, 2018 as substantially equivalent to K110585 (Captiva Spine, Inc., 2011) and 6 other predicates after a 133-day review. Its family tree reaches back 21 generations to 1984. 1 of the 325 devices in its family, counting itself, has a Class I recall.

Decided
Sep 19, 2018
Review
133 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
8

Its longest line of descent runs back 21 generations to K841189 (1984). 324 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 325 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2017: 5 other ancestors2016: 4 other ancestors2015: 9 other ancestors2012: 16 other ancestors2011: 29 other ancestors2014: 17 other ancestors2010: 20 other ancestors2009: 31 other ancestors2008: 45 other ancestors, 1 with a Class I recall12001: 10 other ancestors2013: 16 other ancestors2007: 15 other ancestors2006: 11 other ancestors2005: 18 other ancestors2004: 26 other ancestors2002: 8 other ancestors1999: 2 other ancestors2003: 15 other ancestors2000: 1 other ancestor1996: 2 other ancestors1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestorK841189 · 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. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K160924 · Amendia Interbody Fusion Devices · Amendia, Inc. · 2016K171351 · Posterior Spine Truss System (PSTS) Interbody Fusion Device · 4Web, Inc. · 2017K180990 · TirboLOX-L Lumbar IBFD · Captiva Spine, Inc. · 201819801990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 18 other ancestors3 generations back: 42 other ancestors4 generations back: 70 other ancestors, 1 with a Class I recall15 generations back: 65 other ancestors6 generations back: 51 other ancestors7 generations back: 33 other ancestors8 generations back: 12 other ancestors9 generations back: 5 other ancestors10 generations back: 1 other ancestor K180990 · TirboLOX-L Lumbar IBFD · Captiva Spine, Inc. · 2018K171351 · Posterior Spine Truss System (PSTS) Interbody Fusion Device · 4Web, Inc. · 2017K160924 · Amendia Interbody Fusion Devices · Amendia, Inc. · 2016K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 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. · 1984−20−15−10−50
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 17 generations between
  3. 3 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  4. 2 generations backK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
  5. 1 generation backK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  6. This deviceK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
Show all 21 generations
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 4 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
  19. 3 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  20. 2 generations backK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
  21. 1 generation backK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  22. This deviceK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018

Class I recalls in this family

  • K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−20K990148Stackable Cage SystemDepuy Motech Acromed1999—
−19K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−18K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−17K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−16K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−15K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−14K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−13K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−12K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−11K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−10K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−9K121683Acculif TL CageCoalign Innovations, Inc.2012—
−8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−7K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−6K141217Acculif TL and PL CageStryker Corporation20143
−5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral…Meditech Spine, LLC2015—
−3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016—
−2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.2017—
−1K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.2018—
0 (this device)K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199620
199810
199920
200010
2001100
200280
2003150
2004260
2005180
2006110
2007150
2008451
2009310
2010200
2011290
2012160
2013160
2014170
201590
201640
201750
FIG. 1 — Lineage of K181229, 1984–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K110585Captiva Spine Fuselox Cervical Cage
Summary page 4
…sion Device (21 CFR §888.3080) Name Product Code ODP Classification Division of Orthopedic Devices Panel Predicate Primary Predicate: Devices • K110585: FuseLOX Cervical IBF System, Captiva Spine, Inc. Additional Predicates: • K180990, TirboLO…
Captiva Spine, Inc.2011—
*K180990TirboLOX-L Lumbar IBFD
Cleared while this submission was under review
Summary page 4
…Primary Predicate: Devices • K110585: FuseLOX Cervical IBF System, Captiva Spine, Inc. Additional Predicates: • K180990, TirboLOX-L™ Lumbar IBFD, Captiva Spine Inc. • K150765, K1251103, K113559: ROI-C, LDR •…
Captiva Spine, Inc.2018—
*K150765LDR Spine ROI-C Cervical Cage System
Summary page 4
…BF System, Captiva Spine, Inc. Additional Predicates: • K180990, TirboLOX-L™ Lumbar IBFD, Captiva Spine Inc. • K150765, K1251103, K113559: ROI-C, LDR • K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion…
Ldr Spine USA2015—
Kept off the family treeK125110ROI-C
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 4
…, Captiva Spine, Inc. Additional Predicates: • K180990, TirboLOX-L™ Lumbar IBFD, Captiva Spine Inc. • K150765, K1251103, K113559: ROI-C, LDR • K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion…
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 4
…Spine, Inc. Additional Predicates: • K180990, TirboLOX-L™ Lumbar IBFD, Captiva Spine Inc. • K150765, K1251103, K113559: ROI-C, LDR • K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF)…
Ldr Spine USA, Inc.2011—
*K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Summary page 4
…dicates: • K180990, TirboLOX-L™ Lumbar IBFD, Captiva Spine Inc. • K150765, K1251103, K113559: ROI-C, LDR • K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies, Inco…
Renovis Surgical Technologies2016—
*K120275Synthes Acis/Vertebral Spacer CR
Summary page 4
…K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies, Incorporated • K120275: Synthes ACIS, Synthes Spine • K170550: Camber Spine Technologies Coveris Cervical Cage…
Synthes (Usa), LLC2012—
*K170550Coveris Cervical Cage System
Summary page 4
…ion (ACF) System, Renovis Surgical Technologies, Incorporated • K120275: Synthes ACIS, Synthes Spine • K170550: Camber Spine Technologies Coveris Cervical Cage System, Camber Spine Submission The purpose of th…
Camber Spine Technologies2017—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 34 years and passes through 15 companies; a new generation was cleared every 10 months on median.
  • 35 of the 324 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc…

Read the full statement (117 words)

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Captiva Spine, Inc.

8 FDA decisions under this applicant name. See the company

  • K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2020
  • K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  • K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2018
  • K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 20121 recall
  • K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K181229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181229: TirboLOX-C Cervical IBFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181229

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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