510(k) · Cleared
Recalled · 2010VU Apod Intervertabral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 2, 2008 as substantially equivalent to K050058 (Theken Surgical,Llc, 2005) and 2 other predicates after a 100-day review. Its family tree reaches back 7 generations to 1984. 1 of the 722 devices in its family, counting itself, has a Class I recall. 708 later devices descend from it. It has been recalled once.
- Decided
- Jul 2, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- OVD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 13 ancestors in all. 708 later devices descend from it, 9 citing it directly. 1 of the 722 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 1 generation backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- This deviceK080822 VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC · 2008
- Descendant · cites it directly · 601 of its ownK112359 Prow FusionNlt Spine, Ltd. · 2011
- Descendant · 2 generations on · 593 of its ownK130820 Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013
- Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · cites it directly · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 708 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 708 · See all- K112359Prow FusionNlt Spine, Ltd. · 2011 · cites it directly601descendants
- K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2013 · 2 generations on593descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
- K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · cites it directly480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −1 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| 0 (this device) | K080822 | VU Apod Intervertabral Body Fusion Device | Theken Spine, LLC | 2008 | — |
| +1 | K112359 | Prow Fusion | Nlt Spine, Ltd. | 2011 | — |
| +2 | K130820 | Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2013 | — |
| +3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +1 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 32 | 0 |
| 2017 | 39 | 0 |
| 2018 | 43 | 0 |
| 2019 | 58 | 0 |
| 2020 | 78 | 0 |
| 2021 | 59 | 1 |
| 2022 | 67 | 0 |
| 2023 | 79 | 0 |
| 2024 | 86 | 0 |
| 2025 | 74 | 0 |
| 2026 | 61 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K050058 | Theken Reveal VBR SystemSummary page 1…nal Intervertebral Body Fusion Device (per 21 CFR 888.3080) Class II (per 21 CFR 888.3080) Panel: Orthopedic, Product Code: MAX Theken Surgical, LLC REVEAL VBR System (K050058) DePuy Acromed Lumbar I/F Cage (P960025) Spinal Elements, Lucent Magnum (K073348) Polyetheretherketone (PEEK-OPTIMA LT) per ASTM… | 2005 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…er 21 CFR 888.3080) Class II (per 21 CFR 888.3080) Panel: Orthopedic, Product Code: MAX Theken Surgical, LLC REVEAL VBR System (K050058) DePuy Acromed Lumbar I/F Cage (P960025) Spinal Elements, Lucent Magnum (K073348) Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026 Tantalum per ASTM F-560 Titanium… | 1999 |
| * | K073348 | Lucent MagnumSummary page 1…888.3080) Panel: Orthopedic, Product Code: MAX Theken Surgical, LLC REVEAL VBR System (K050058) DePuy Acromed Lumbar I/F Cage (P960025) Spinal Elements, Lucent Magnum (K073348) Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026 Tantalum per ASTM F-560 Titanium 6Al-4V ELI per ASTM F-136 The Vu aPOD I… | 2007 |
What descends from it? (708)
See all 7089 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112359 | Prow Fusion | 2011 | 601 |
| K101310 | VU Apod Intervertebral Body Fusion Device | 2010 | 480 |
| K112986 | Lateral Fusion Device | 2012 | 126 |
| K082712 | Theken Spine VU Epod and VU Lpod System | 2009 | 118 |
| K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu… | 2018 | 59 |
| K123969 | Xiphos | 2013 | 14 |
| K221719 | ABTross ALIF Expandable Cage System | 2022 | 2 |
| K112493 | Pass LP Spinal System | 2011 | 1 |
| K100544 | Impix Lumbar Interbody Device | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2010 | Not classified | Z-1475-2011 | Employee error | The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used… |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K112359 (Nlt Spine, Ltd., 2011) has gone furthest, with 601 descendants of its own.
- 6 other devices also cite its predicate K050058.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use…
Read the full statement (129 words)
The Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic origin 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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080822: VU Apod Intervertabral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080822
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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