510(k) · Cleared
ClearedDualX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasive, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 27, 2018 as substantially equivalent to K123281 (Coalign Innovations, Inc., 2013) and 5 other predicates after a 121-day review. Its family tree reaches back 19 generations to 1984. 15 later devices descend from it.
- Decided
- Sep 27, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K841189 (1984). 309 ancestors in all, the oldest K792352 (1979). 15 later devices descend from it, 5 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152651 AccuLIF TL and PL CageStryker Corporation · 2015
- This deviceK181397 DualXInnovasive, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK222203 DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK221894 Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231275 Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152651 AccuLIF TL and PL CageStryker Corporation · 2015
- This deviceK181397 DualXInnovasive, Inc. · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · cites it directly5descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 2 generations on4descendants
- K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc. · 2022 · cites it directly3descendants
- K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023 · 2 generations on2descendants
- K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −1 | K152651 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | — |
| 0 (this device) | K181397 | DualX | Innovasive, Inc. | 2018 | — |
| +1 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +2 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
| +1 | K222203 | DualXSLIM (R) T/PLIF | Amplify Surgical, Inc. | 2022 | — |
| +2 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | 2023 | — |
| +2 | K231275 | Exceed™ Biplanar Expandable Interbody System | Spine Wave, Inc. | 2023 | — |
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 | 19 | 0 |
| 2004 | 37 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 16 | 0 |
| 2008 | 39 | 0 |
| 2009 | 23 | 0 |
| 2010 | 20 | 0 |
| 2011 | 21 | 0 |
| 2012 | 10 | 0 |
| 2013 | 14 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K123281 | Acculif TL-Peek CageSummary page 7…of the following predicate devices: 510(k) Trade or Proprietary or Model Manufacturer Designation Number Name K123281 AccuLIF® TL-PEEK Cage Coalign Innovations, Inc. Primary K152651 AccuLIF® TL and PL Cage… | 2013 |
| * | K152651 | AccuLIF TL and PL CageSummary page 7…Manufacturer Designation Number Name K123281 AccuLIF® TL-PEEK Cage Coalign Innovations, Inc. Primary K152651 AccuLIF® TL and PL Cage Coalign Innovations, Inc. Additional K120966 PULSE™ Lumbar Cage System… | 2015 |
| * | K120966 | Depuy Pulse Lumbar Cage SystemSummary page 7…AccuLIF® TL-PEEK Cage Coalign Innovations, Inc. Primary K152651 AccuLIF® TL and PL Cage Coalign Innovations, Inc. Additional K120966 PULSE™ Lumbar Cage System DePuy Spine Additional K171519 FLXfit™… | 2012 |
| * | K171519 | FLXfit™Summary page 7…ccuLIF® TL and PL Cage Coalign Innovations, Inc. Additional K120966 PULSE™ Lumbar Cage System DePuy Spine Additional K171519 FLXfit™ Expanding Orthopedics Additional K161379 Elsa… | 2017 |
| * | K161379 | ELSA SpacersSummary page 7…ULSE™ Lumbar Cage System DePuy Spine Additional K171519 FLXfit™ Expanding Orthopedics Additional K161379 Elsa Globus Medical, Inc. Additional K113447 Rise… | 2016 |
| * | K113447 | Rise SpacerSummary page 7…LXfit™ Expanding Orthopedics Additional K161379 Elsa Globus Medical, Inc. Additional K113447 Rise Globus Medical, Inc. Additional TECHNOLOGICAL CHARACTERISTICS After entering t… | 2012 |
What descends from it? (15)
See all 155 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 34 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 33 of the 309 ancestors have a recall of any class.
- Of its descendants, K203038 (Integrity Implants, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K123281.
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 DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for…
Read the full statement (286 words)
The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualX™ PLIF is indicated for unilateral or Bilateral implantation.
The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181397: DualX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181397
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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