510(k) · Cleared
ClearedVU Apod Intervertebral 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 Jun 27, 2012 as substantially equivalent to K101310 (Theken Spine, LLC, 2010) after a 68-day review. Its family tree reaches back 13 generations to 1984. 129 later devices descend from it.
- Decided
- Jun 27, 2012
- Review
- 68 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K841189 (1984). 54 ancestors in all. 129 later devices descend from it, 6 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK121211 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2012
- Descendant · cites it directly · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 74 of its ownK162236 Ax Stand-Alone ALIF SystemInnovasis, Inc. · 2017
- Descendant · 2 generations on · 72 of its ownK182139 AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc. · 2019
- Descendant · 2 generations on · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 64 of its ownK181818 Scarlet AL-TSpineart · 2018
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- This deviceK121211 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2012
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · cites it directly79descendants
- K162236Ax Stand-Alone ALIF SystemInnovasis, Inc. · 2017 · cites it directly74descendants
- K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc. · 2019 · 2 generations on72descendants
- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · 2 generations on67descendants
- K181818Scarlet AL-TSpineart · 2018 · cites it directly64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −1 | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| 0 (this device) | K121211 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2012 | — |
| +1 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K162236 | Ax Stand-Alone ALIF System | Innovasis, Inc. | 2017 | — |
| +2 | K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | 2019 | — |
| +2 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K181818 | Scarlet AL-T | Spineart | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 15 | 0 |
| 2023 | 20 | 0 |
| 2024 | 27 | 0 |
| 2025 | 22 | 0 |
| 2026 | 20 | 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 OVD? 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? (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 |
|---|---|---|---|
| * | K101310 | VU Apod Intervertebral Body Fusion DeviceSummary page 1…r Class: I Product Code: OVID Predicate Device: Integra Vu aPOD Intervertebral Body Fusion Device (K101310) Device Description: The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as… | 2010 |
What descends from it? (129)
See all 1296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | 2016 | 79 |
| K162236 | Ax Stand-Alone ALIF System | 2017 | 74 |
| K181818 | Scarlet AL-T | 2018 | 64 |
| K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu… | 2018 | 59 |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | 2024 | 8 |
| K221719 | ABTross ALIF Expandable Cage System | 2022 | 2 |
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 28 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 54 ancestors have a recall of any class.
- Of its descendants, K162351 (SeaSpine Orthopedics Corporation, 2016) has gone furthest, with 79 descendants of its own.
- 10 other devices also cite its predicate K101310.
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. 2012, 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?
When used with the bone screws, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si:' DOID is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DIDD patients may also have up to Grade 1 spondylolisthesis at the involved…
Read the full statement (301 words)
When used with the bone screws, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si:' DOID is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DIDD 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.
When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (ODD) at one or two contiguous levels from L2 to Si. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies These OIDD 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. When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Integra Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand alone device. If the Integra Spine Vu aPod Intervertebral Body Fusion Device is used only with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121211: VU Apod 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/K121211
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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