510(k) · Cleared
ClearedVU E*Pod Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 30, 2007 as substantially equivalent to K032064 (Theken Surgical,Llc, 2004) and 1 other predicate after a 110-day review. Its family tree reaches back 7 generations to 1984. 119 later devices descend from it.
- Decided
- Jul 30, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K841189 (1984). 11 ancestors in all. 119 later devices descend from it, 1 citing it directly.
- 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 deviceK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- Descendant · cites it directly · 118 of its ownK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- Descendant · 2 generations on · 116 of its ownK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- Descendant · 3 generations on · 103 of its ownK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
- Descendant · 4 generations on · 82 of its ownK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 3 generations on · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009 · cites it directly118descendants
- K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc. · 2014 · 2 generations on116descendants
- K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation · 2016 · 3 generations on103descendants
- K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017 · 4 generations on82descendants
- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · 3 generations on79descendants
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) | K071031 | VU E*Pod Vertebral Body Replacement | Theken Spine, LLC | 2007 | — |
| +1 | K082712 | Theken Spine VU Epod and VU Lpod System | Theken Spine, LLC | 2009 | — |
| +2 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene… | Seaspine, Inc. | 2014 | — |
| +3 | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene… | SeaSpine Orthopedics Corporation | 2016 | — |
| +4 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| +3 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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 MQP? 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? (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 |
|---|---|---|---|
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 1…Panel: Orthopedic, Product Code: MQP, Panel Code: 87 Predicate Device: Theken Surgical, LLC CPOD/LPOD VBR System (K032064) Theken Surgical, LLC REVEAL VBR System (K050058) Material Composition: Poly… | 2004 |
| * | K050058 | Theken Reveal VBR SystemSummary page 1…87 Predicate Device: Theken Surgical, LLC CPOD/LPOD VBR System (K032064) Theken Surgical, LLC REVEAL VBR System (K050058) Material Composition: Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026… | 2005 |
What descends from it? (119)
See all 1191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082712 | Theken Spine VU Epod and VU Lpod System | 2009 | 118 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K082712 (Theken Spine, LLC, 2009) has gone furthest, with 118 descendants of its own.
- 7 other devices also cite its predicate K032064.
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. 2007, 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 Vu e*POD Vertebral Body Replacement is indicated for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture). The Vu e.POD Vertebral Body Replacement is designed to restore the bionmechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the…
Read the full statement (120 words)
The Vu e*POD Vertebral Body Replacement is indicated for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture).
The Vu e.POD Vertebral Body Replacement is designed to restore the bionmechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.
The Vu e*POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical, LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071031 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071031: VU E*Pod Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071031
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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