510(k) · Cleared
ClearedToro-L Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Implants, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 26, 2021 as substantially equivalent to K181397 (Innovasive, Inc., 2018) and 4 other predicates after a 171-day review. Its family tree reaches back 21 generations to 1984. 5 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 171 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K841189 (1984). 388 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK173025 NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2018
- This deviceK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253401 SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232996 Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF…Shanghai Iatrical-Ti Technologies CO, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK234035 COSINE™ SpacerGlobus Medical, Inc. · 2024
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 1 generation backK173025 NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2018
- This deviceK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · cites it directly4descendants
- K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023 · cites it directly2descendants
- K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026 · 2 generations on0descendants
- K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd. · 2024 · 2 generations on0descendants
- K234035COSINE™ SpacerGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K173025 | NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive®… | Nu Vasive, Incorporated | 2018 | — |
| 0 (this device) | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +1 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
| +1 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | — |
| +2 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | — |
| +2 | K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO, Ltd. | 2024 | — |
| +2 | K234035 | COSINE™ Spacer | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 39 | 0 |
| 2005 | 26 | 0 |
| 2006 | 13 | 0 |
| 2007 | 17 | 0 |
| 2008 | 45 | 0 |
| 2009 | 31 | 0 |
| 2010 | 25 | 0 |
| 2011 | 28 | 0 |
| 2012 | 15 | 0 |
| 2013 | 22 | 0 |
| 2014 | 20 | 0 |
| 2015 | 16 | 0 |
| 2016 | 7 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 MAX? 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? (5)
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 |
|---|---|---|---|
| * | K181397 | DualXSummary page 6…To demonstrate the substantial equivalence of the subject Toro-L Interbody Fusion System to legally marketed predicate devices, Amplify Surgical’s DualX LLIF, K181397 (SE 09/27/2018) is used as the primary predicate device. Additionally, the following devices are being used as predic… | 2018 |
| * | K173025 | NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Summary page 6…mary predicate device. Additionally, the following devices are being used as predicate devices for this submission: x Nuvasive’s AP Expandable XLIF System, K173025 (SE 02/08/2018) x Globus Medical’s Rise-L Spacers, K113447 (SE 01/26/2012) x Medtronic’s Capstone-L Spinal System… | 2018 |
| * | K113447 | Rise SpacerSummary page 6…e being used as predicate devices for this submission: x Nuvasive’s AP Expandable XLIF System, K173025 (SE 02/08/2018) x Globus Medical’s Rise-L Spacers, K113447 (SE 01/26/2012) x Medtronic’s Capstone-L Spinal System, K123978 (SE 04/09/2013) x Integrity Implants’ FlareHawk7… | 2012 |
| * | K123978 | Capstone L Spinal SystemSummary page 6…e’s AP Expandable XLIF System, K173025 (SE 02/08/2018) x Globus Medical’s Rise-L Spacers, K113447 (SE 01/26/2012) x Medtronic’s Capstone-L Spinal System, K123978 (SE 04/09/2013) x Integrity Implants’ FlareHawk7 Interbody Fusion System, K183184 (SE 04/03/2019) X. Brief Discussio… | 2013 |
| * | K183184 | FlareHawk Interbody Fusion SystemSummary page 6…pacers, K113447 (SE 01/26/2012) x Medtronic’s Capstone-L Spinal System, K123978 (SE 04/09/2013) x Integrity Implants’ FlareHawk7 Interbody Fusion System, K183184 (SE 04/03/2019) X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted Integrity Implants has conducted… | 2019 |
What descends from it? (5)
2 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 37 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 42 of the 388 ancestors have a recall of any class.
- Of its descendants, K213355 (Integrity Implants, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K181397.
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. 2021, 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 Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in…
Read the full statement (188 words)
The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Toro-L Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
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/K203038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203038: Toro-L Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203038
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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