510(k) · Cleared
ClearedVertebron VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebron, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 24, 2008 as substantially equivalent to K073144 (Lanx, LLC, 2008) and 3 other predicates after a 102-day review. Its family tree reaches back 9 generations to 1984. 1 of the 40 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Mar 24, 2008
- Review
- 102 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K841189 (1984). 27 ancestors in all. 12 later devices descend from it, 7 citing it directly. 1 of the 40 devices in this family, counting this one, has a Class I recall.
- 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 deviceK073502 Vertebron VBR SystemVertebron, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 2 of its ownK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 2 of its ownK141443 Infront Lumbar Interbody Fusion SystemInfront Medical, LLC · 2014
- Descendant · cites it directly · 1 of its ownK182406 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 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 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 deviceK073502 Vertebron VBR SystemVertebron, Inc. · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
Most influential descendants
Showing 5 of 12 · See all- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly8descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on6descendants
- K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly2descendants
- K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC · 2014 · cites it directly2descendants
- K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2019 · cites it directly1descendant
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) | K073502 | Vertebron VBR System | Vertebron, Inc. | 2008 | — |
| +1 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K141443 | Infront Lumbar Interbody Fusion System | Infront Medical, LLC | 2014 | — |
| +1 | K182406 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2019 | — |
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 | 3 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K073144 | Lanx Intervertebral Body Fusion Device Cleared while this submission was under review Summary page 1…COMMON NAME: Intervertebral Body Fusion Device PROPRIETARY NAME: VERTEBRON Interbody Fusion System PREDICATE DEVICES: Lanx K073144 Globus Medical K072970 Innovative Spine K072120… | 2008 |
| * | K072970 | Patriot Spacers Cleared while this submission was under review Summary page 1…usion Device PROPRIETARY NAME: VERTEBRON Interbody Fusion System PREDICATE DEVICES: Lanx K073144 Globus Medical K072970 Innovative Spine K072120 Abbott Spine K073202 DEVICE DESCRIPTION:… | 2008 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 1…nterbody Fusion System PREDICATE DEVICES: Lanx K073144 Globus Medical K072970 Innovative Spine K072120 Abbott Spine K073202 DEVICE DESCRIPTION: The VERTEBRON Interbody Fusion System consis… | 2007 |
| * | K073202 | Ardis Spacer Cleared while this submission was under review Summary page 1…Lanx K073144 Globus Medical K072970 Innovative Spine K072120 Abbott Spine K073202 DEVICE DESCRIPTION: The VERTEBRON Interbody Fusion System consists of various heights… | 2008 |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160976 | Altus Spine Interbody Fusion System | 2017 | 8 |
| K171329 | Altus Spine Titanium Interbody Fusion System | 2017 | 2 |
| K141443 | Infront Lumbar Interbody Fusion System | 2014 | 2 |
| K182406 | Altus Spine Interbody Fusion System | 2019 | 1 |
| K181030 | Rubicon Lumbar Interbody Fusion System | 2018 | 0 |
| K170553 | Altus Spine Interbody Fusion System | 2017 | 0 |
| K172253 | Altus Spine Cervical Interbody Fusion System | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160976 (Altus Partners, LLC, 2017) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K073144.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal…
Read the full statement (120 words)
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone
graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two
contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. These patients
should have had six months of non-operative treatment. These DDD patients may have
had a previous non-fusion spinal surgery at the involved spinal level(s), and may have
up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior
approach and is to be combined with cleared supplemental fixation systems, such as the
VERTEBRON PSS Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073502: Vertebron VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073502
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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