510(k) · Cleared
ClearedInterfuse L Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebral Technologies, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 3, 2013 as substantially equivalent to K091988 (Vertebral Technologies, Inc., 2009) and 2 other predicates after a 97-day review. Its family tree reaches back 9 generations to 1984. 6 later devices descend from it.
- Decided
- Sep 3, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K841189 (1984). 38 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- 2 generations backK103666 Lanx LateralLanx, Inc. · 2011
- 1 generation backK123207 Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012
- This deviceK131540 Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc. · 2013
- 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 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 6 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 5 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 4 generations backK052384 Lanx VBR SystemLanx, LLC · 2005
- 3 generations backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- 2 generations backK103666 Lanx LateralLanx, Inc. · 2011
- 1 generation backK123207 Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012
- This deviceK131540 Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc. · 2013
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 |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −6 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −5 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −4 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| −3 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| −2 | K103666 | Lanx Lateral | Lanx, Inc. | 2011 | — |
| −1 | K123207 | Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion System | Osteomed LP | 2012 | — |
| 0 (this device) | K131540 | Interfuse L Intervertebral Body Fusion Device | Vertebral Technologies, Inc. | 2013 | — |
| +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 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K091988 | Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Summary page 1…ivalent in performiance, indication, design and material to: 1. InterFuse S intervertebral Body Fusion Device (cleared under Premarket notification # K091988) 2. InterFuseT Intervertebral Body Fusion Device (cleared under Premarket notification # K102277) 3. Prim… | 2009 |
| * | K102277 | Interfuse T Invertebral Body Fusion DeviceSummary page 1…evice (cleared under Premarket notification # K091988) 2. InterFuseT Intervertebral Body Fusion Device (cleared under Premarket notification # K102277) 3. PrimaLlE LLIF Unitary PEEK Lateral Interbody Fusion System (cleared under Premarket notification # K123207)… | 2010 |
| * | K123207 | Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemSummary page 1…under Premarket notification # K102277) 3. PrimaLlE LLIF Unitary PEEK Lateral Interbody Fusion System (cleared under Premarket notification # K123207) 4.2 DEVICE DESCRIPTION K13… | 2012 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K160074 (Spineology, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K091988.
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. 2013, 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 InterFuse L - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The…
Read the full statement (137 words)
The InterFuse L - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures 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. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse L device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse L device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131540: Interfuse L Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131540
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