510(k) · Cleared
ClearedDuo Lumbar Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 7, 2019 as substantially equivalent to K182322 (Spineology, Inc., 2018) and 2 other predicates after a 55-day review. Its family tree reaches back 16 generations to 1984. 1 later device descends from it.
- Decided
- Mar 7, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 104 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK171660 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
- 2 generations backK181792 Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- 1 generation backK182322 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- This deviceK190055 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK210155 Duo Expandable Interbody Fusion SystemSpineology, Inc. · 2021
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK150954 Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC · 2015
- 4 generations backK160074 Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016
- 3 generations backK171660 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
- 2 generations backK181792 Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- 1 generation backK182322 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- This deviceK190055 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K210155Duo Expandable Interbody Fusion SystemSpineology, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K150954 | Elite L Expandable Lumbar Fusion System | Innova Spinal Technologies, LLC | 2015 | — |
| −4 | K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016 | — |
| −3 | K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| −2 | K181792 | Duo™ Lumbar Interbody Fusion Device | Spineology, Inc. | 2018 | — |
| −1 | K182322 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2018 | — |
| 0 (this device) | K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2019 | — |
| +1 | K210155 | Duo Expandable Interbody Fusion System | Spineology, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K182322 | Duo Lumbar Interbody Fusion DeviceSummary page 4…lass: Class II Regulation Number: 21 CFR 888.3080 Panel: Orthopedic Predicate Devices: Primary: K182322, K181792 Duo Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K123767 Lanx Fusion System (now Timb… | 2018 |
| * | K181792 | Duo™ Lumbar Interbody Fusion DeviceSummary page 4…Class II Regulation Number: 21 CFR 888.3080 Panel: Orthopedic Predicate Devices: Primary: K182322, K181792 Duo Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K123767 Lanx Fusion System (now Timberline La… | 2018 |
| * | K123767 | Lanx Fusion System- SASummary page 4…Orthopedic Predicate Devices: Primary: K182322, K181792 Duo Lumbar Interbody Fusion Device (Spineology Inc.) Additional: K123767 Lanx Fusion System (now Timberline Lateral Fusion System) A. Purpose of Submission The purpose of this premarket no… | 2013 |
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 |
|---|---|---|---|
| K210155 | Duo Expandable Interbody Fusion System | 2021 | 0 |
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 35 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 104 ancestors have a recall of any class.
- Of its descendants, K210155 (Spineology, Inc., 2021) has gone furthest, with 0 descendants of its own.
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. 2019, 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 Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had…
Read the full statement (121 words)
The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190055 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190055: Duo Lumbar Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190055
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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