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 Sep 2, 2010 as substantially equivalent to K080822 (Theken Spine, LLC, 2008) and 3 other predicates after a 114-day review. Its family tree reaches back 12 generations to 1984. 1 of the 534 devices in its family, counting itself, has a Class I recall. 480 later devices descend from it.
- Decided
- Sep 2, 2010
- Review
- 114 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 53 ancestors in all. 480 later devices descend from it, 11 citing it directly. 1 of the 534 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- This deviceK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
- Descendant · cites it directly · 460 of its ownK133286 Midline (TM)Centinel Spine, Inc. · 2014
- Descendant · cites it directly · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
- Descendant · 2 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- Descendant · 3 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- Descendant · 2 generations on · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 2 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 1 generation backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- This deviceK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
Showing 5 of 480 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 480 · See all- K133286Midline (TM)Centinel Spine, Inc. · 2014 · cites it directly460descendants
- K141942Midline II TICentinel Spine, Inc. · 2014 · cites it directly459descendants
- K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 2 generations on368descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 3 generations on236descendants
- K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015 · 2 generations on220descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −1 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| 0 (this device) | K101310 | VU Apod Intervertebral Body Fusion Device | Theken Spine, LLC | 2010 | — |
| +1 | K133286 | Midline (TM) | Centinel Spine, Inc. | 2014 | — |
| +1 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| +2 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| +3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| +2 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 13 | 0 |
| 2017 | 14 | 0 |
| 2018 | 21 | 0 |
| 2019 | 33 | 0 |
| 2020 | 44 | 0 |
| 2021 | 43 | 1 |
| 2022 | 54 | 0 |
| 2023 | 58 | 0 |
| 2024 | 78 | 0 |
| 2025 | 62 | 0 |
| 2026 | 52 | 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? (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 |
|---|---|---|---|
| * | K080822 | VU Apod Intervertabral Body Fusion DeviceSummary page 2…vice(s): The Vu aPOD Intervertcbral Body Fusion Device was shown to be substantially equivalent to previously cleared devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and L.LDR Spine ROI-A (K082262), and has the… | 2008 |
| * | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd)Summary page 2…y Fusion Device was shown to be substantially equivalent to previously cleared devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and L.LDR Spine ROI-A (K082262), and has the same indications for use, design, and [… | 2008 |
| * | K083475 | Lucent MagnumSummary page 2…ly equivalent to previously cleared devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and L.LDR Spine ROI-A (K082262), and has the same indications for use, design, and [unction. Performance Standards: Preclinic… | 2009 |
| * | K082262 | LDR Spine Roi Interbody Fusion SystemSummary page 2…ed devices, including the Theken Spine Vu aPOD System (K080822), Titan Spine Endoskeleton TA (K080615), Spinal Elements Lucent Magnum + (K083475), and L.LDR Spine ROI-A (K082262), and has the same indications for use, design, and [unction. Performance Standards: Preclinical testing has been performed per… | 2009 |
What descends from it? (480)
See all 48011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133286 | Midline (TM) | 2014 | 460 |
| K141942 | Midline II TI | 2014 | 459 |
| K121211 | VU Apod Intervertebral Body Fusion Device | 2012 | 129 |
| K181818 | Scarlet AL-T | 2018 | 64 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | 2020 | 60 |
| K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu… | 2018 | 59 |
| K210583 | SeaSpine WaveForm™ A Interbody System | 2021 | 14 |
| K124034 | Mectalif Anterior | 2013 | 11 |
| K160605 | MectaLIF Anterior Stand-Alone | 2016 | 10 |
| K212498 | Stable-L Standalone Lumbar Interbody System | 2022 | 7 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 53 ancestors have a recall of any class.
- Of its descendants, K133286 (Centinel Spine, Inc., 2014) has gone furthest, with 460 descendants of its own.
- 8 other devices also cite its predicate K080822.
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. 2010, 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 Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved…
Read the full statement (318 words)
When used with the bone screws, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 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.
When used with the SpinPlate, the Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies 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. When used with the SpinPlate, 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.
The Theken Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws, is a stand alone device. If the Theken Spine Vu aPod Intervertebral Body Fusion Device is used 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. The SpinPlate and bone screws are not intended to be used together. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101310: 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/K101310
Report an extraction error
Are you the manufacturer?
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