510(k) · Cleared
ClearedAdvanced Vertebral Solutions Express BFD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vertebral Solutions, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 23, 2010 as substantially equivalent to K072120 (Innovative Spinal Technologies, Inc., 2007) and 1 other predicate after a 260-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Sep 23, 2010
- Review
- 260 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K841189 (1984). 25 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK100037 Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC · 2010
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 backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK100037 Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC · 2010
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 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K100037 | Advanced Vertebral Solutions Express BFD | Advanced Vertebral Solutions, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 1…r 21 CFR 888.3080 Classification Panel: Orthopedics Product Code MAX Predicate Devices ParamountTM Intervertebral Body Fusion Device (K072 120) and Patriot TM Intervertebral Body Fusion Device (K072970) Device Description Advanced Vertebral… | 2007 |
| * | K072970 | Patriot SpacersSummary page 1…MAX Predicate Devices ParamountTM Intervertebral Body Fusion Device (K072 120) and Patriot TM Intervertebral Body Fusion Device (K072970) Device Description Advanced Vertebral Solutions Express IBFD AVS Express is a device for interbod… | 2008 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 7 other devices also cite its predicate K072120.
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. 2010, 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 Advanced Vertebral Solutions EXPRESS IBFD, when used with autologous bone graft, is indicated for use in patients wNith Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be…
Read the full statement (111 words)
The Advanced Vertebral Solutions EXPRESS IBFD, when used with autologous bone graft, is indicated for use in patients wNith Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Advanced Vertebral Solutions EXPRESS II3FD is to be implanted via a transforaminal approach. The device is to be used singly in the lunibosacral spine with supplemental posterior fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100037: Advanced Vertebral Solutions Express BFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100037
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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