510(k) · Cleared
ClearedTirboLOX-L Lumbar IBFD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Captiva Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 13, 2018 as substantially equivalent to K171351 (4Web, Inc., 2017) and 5 other predicates after a 119-day review. Its family tree reaches back 20 generations to 1984. 1 of the 293 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 13, 2018
- Review
- 119 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K841189 (1984). 291 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 293 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- 1 generation backK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
- This deviceK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- 1 generation backK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
- This deviceK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −2 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| −1 | K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | 4Web, Inc. | 2017 | — |
| 0 (this device) | K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | 2018 | — |
| +1 | K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018 | — |
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 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 23 | 0 |
| 2005 | 18 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 41 | 1 |
| 2009 | 28 | 0 |
| 2010 | 16 | 0 |
| 2011 | 27 | 0 |
| 2012 | 14 | 0 |
| 2013 | 16 | 0 |
| 2014 | 16 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion DeviceSummary page 4…sion Device (21 CFR §888.3080) Name Product Code MAX Classification Division of Orthopedic Devices Panel Predicate Primary Predicate: Devices • K171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4WEB, Inc. Additional Predi… | 2017 |
| * | K122956 | Fuselox Lumbar Interbody Fusion DeviceSummary page 4…• K171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device, 4WEB, Inc. Additional Predicates: • K122956 FuseLOX® Lumbar Interbody System, Captiva Spine, Inc. • K150481 Cascadia Interbody System, K2M… | 2012 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…Device, 4WEB, Inc. Additional Predicates: • K122956 FuseLOX® Lumbar Interbody System, Captiva Spine, Inc. • K150481 Cascadia Interbody System, K2M • K172888 EIT Cellular Titanium PLIF Cages, EIT Emerging Implant… | 2015 |
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 4…• K122956 FuseLOX® Lumbar Interbody System, Captiva Spine, Inc. • K150481 Cascadia Interbody System, K2M • K172888 EIT Cellular Titanium PLIF Cages, EIT Emerging Implant Technologies GmbH • K170341 M… | 2017 |
| * | K170341 | Medussa-PL CageSummary page 4…erbody System, K2M • K172888 EIT Cellular Titanium PLIF Cages, EIT Emerging Implant Technologies GmbH • K170341 Medussa-PL Cage, Medyssey USA, Inc. • K153400 ProLift® Expandable System, Life Spine Submission The pu… | 2017 |
| * | K153400 | ProLift Expandable SystemSummary page 4…nium PLIF Cages, EIT Emerging Implant Technologies GmbH • K170341 Medussa-PL Cage, Medyssey USA, Inc. • K153400 ProLift® Expandable System, Life Spine Submission The purpose of this submission is to request market clearance for a new S… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181229 | TirboLOX-C Cervical IBFD | 2018 | 0 |
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 · 3 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 11 months on median.
- 34 of the 291 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181229 (Captiva Spine, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171351.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Captiva Spine TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocortical bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).
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/K180990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180990: TirboLOX-L Lumbar IBFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180990
Report an extraction error
Are you the manufacturer?
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