510(k) · Cleared
ClearedInterfuse DA Invertebral 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 Feb 3, 2011 as substantially equivalent to K091988 (Vertebral Technologies, Inc., 2009) after a 28-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 3, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010530 (2001). 8 ancestors in all, the oldest P950002 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 2 generations backK080673 Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc. · 2008
- 1 generation backK091988 Modification to: Interfuse Intervertebral Body Fusion Device , Model…Vertebral Technologies, Inc. · 2009
- This deviceK110045 Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −3 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −2 | K080673 | Interfuse Intervertebral Body Fusion Device | Vertebral Technologies, Inc. | 2008 | — |
| −1 | K091988 | Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076 | Vertebral Technologies, Inc. | 2009 | — |
| 0 (this device) | K110045 | Interfuse DA Invertebral Body Fusion Device | Vertebral Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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? (1)
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…equivalent in performance, indication, design and material to VTI's own InterFuse 4DP Intervertebral Body Fusion Device cleared under Premarket notification # K091988. Vertebral Technologies, Inc. ~* InterFuse DA Intervertebral Body Fusion Device Special 5… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2011, 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 lnterFuseo DA Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2-S1. ODD 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 (136 words)
The lnterFuseo DA Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2-S1. ODD 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 DA 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 DA 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/K110045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110045: Interfuse DA Invertebral 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/K110045
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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