510(k) · Cleared
ClearedElite L Expandable Lumbar Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Spinal Technologies, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 7, 2015 as substantially equivalent to K133459 (Innova Spinal Technologies, LLC, 2014) and 2 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1984. 6 later devices descend from it.
- Decided
- May 7, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 32 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK150954 Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC · 2015
- Descendant · cites it directly · 5 of its ownK160074 Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK171660 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK181792 Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK182322 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK190055 Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 1 generation backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK150954 Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016 · cites it directly5descendants
- K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2017 · 2 generations on4descendants
- K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018 · 3 generations on3descendants
- K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2018 · 4 generations on2descendants
- K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc. · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −1 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K150954 | Elite L Expandable Lumbar Fusion System | Innova Spinal Technologies, LLC | 2015 | — |
| +1 | K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016 | — |
| +2 | K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| +3 | K181792 | Duo™ Lumbar Interbody Fusion Device | Spineology, Inc. | 2018 | — |
| +4 | K182322 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2018 | — |
| +4 | K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K133459 | Elite IbfSummary page 4…to hold the implant in the expanded position once deployed. Predicate Device The predicate devices include the Primary Predicate which is the Elite IBF by Innova Spine (K133459). Additional predicates include the Clydesdale Spinal System from Medtronic (K100175) and the Coroent XL Keeled System by Nuvasiv… | 2014 |
| * | K100175 | Clydesdale Spinal SystemSummary page 4…dicate devices include the Primary Predicate which is the Elite IBF by Innova Spine (K133459). Additional predicates include the Clydesdale Spinal System from Medtronic (K100175) and the Coroent XL Keeled System by Nuvasive (K081611). Intended Use / Indications for Use The ELITE™ L Expandable Lumbar Fusio… | 2010 |
| * | K081611 | Nuvasive Coroent SystemSummary page 4…he Elite IBF by Innova Spine (K133459). Additional predicates include the Clydesdale Spinal System from Medtronic (K100175) and the Coroent XL Keeled System by Nuvasive (K081611). Intended Use / Indications for Use The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fu… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160074 | Rampart D Lumbar Interbody Fusion Device | 2016 | 5 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 32 ancestors have a recall of any class.
- Of its descendants, K160074 (Spineology, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K133459.
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. 2015, 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 ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These…
Read the full statement (108 words)
The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150954: Elite L Expandable Lumbar 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/K150954
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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