510(k) · Cleared
ClearedVU Cpod Intervertebral Bodu Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Clinical Regulatory Advisers · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 16, 2010 as substantially equivalent to K082801 (Us Spine, 2008) and 5 other predicates after a 216-day review. Its family tree reaches back 11 generations to 1984. 1 of the 130 devices in its family, counting itself, has a Class I recall. 78 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 216 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K841189 (1984). 51 ancestors in all. 78 later devices descend from it, 5 citing it directly. 1 of the 130 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK101363 VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers · 2010
- Descendant · cites it directly · 62 of its ownK111675 VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011
- Descendant · cites it directly · 61 of its ownK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 60 of its ownK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 39 of its ownK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK101363 VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers · 2010
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 78 · See all- K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011 · cites it directly62descendants
- K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017 · cites it directly61descendants
- K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · cites it directly60descendants
- K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2021 · 2 generations on39descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −1 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| 0 (this device) | K101363 | VU Cpod Intervertebral Bodu Fusion Device | Musculoskeletal Clinical Regulatory Advisers | 2010 | — |
| +1 | K111675 | VU C*Pod Intervertebral Body Fusion Device | Theken Spine, LLC | 2011 | — |
| +1 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 1 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 11 | 0 |
| 2024 | 14 | 0 |
| 2025 | 14 | 0 |
| 2026 | 12 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K082801 | Phantom Plus Cage System | 2008 |
| * | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesSummary page 2…shown to be substantially equivalent to previously cleared devices, including the US Spine Phantom PLUS Cage System (K08280 I), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cer-vical Cage (K09 1088), Synthes Spine Zero-P Cervical Cage (K072981I), and SpineArt… | 2008 |
| * | K080588 | Scient'x Tribeca VBRSummary page 2…equivalent to previously cleared devices, including the US Spine Phantom PLUS Cage System (K08280 I), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cer-vical Cage (K09 1088), Synthes Spine Zero-P Cervical Cage (K072981I), and SpineArt Tryptik® Cervical Cage (… | 2008 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 2…including the US Spine Phantom PLUS Cage System (K08280 I), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cer-vical Cage (K09 1088), Synthes Spine Zero-P Cervical Cage (K072981I), and SpineArt Tryptik® Cervical Cage (K09 1873). Summary of Technological Charac… | 2009 |
| * | K072981 | Synthes Zero-PSummary page 2…m (K08280 I), Interbody Innovations Zeus Cervical Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cer-vical Cage (K09 1088), Synthes Spine Zero-P Cervical Cage (K072981I), and SpineArt Tryptik® Cervical Cage (K09 1873). Summary of Technological Characteristics: The Vu c-POD Intervertebral Body Fu… | 2008 |
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 2…l Cage (K081614), LDR Spine MC+ (K080588), LDR Spine ROI-C Cer-vical Cage (K09 1088), Synthes Spine Zero-P Cervical Cage (K072981I), and SpineArt Tryptik® Cervical Cage (K09 1873). Summary of Technological Characteristics: The Vu c-POD Intervertebral Body Fusion Device, in comparison to relevant predicate… | 2009 |
What descends from it? (78)
See all 785 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 51 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K111675 (Theken Spine, LLC, 2011) has gone furthest, with 62 descendants of its own.
- 12 other devices also cite its predicate K082801.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Vu c-POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c-POD implants are to be used with autogenous bone graft and implanted via…
Read the full statement (120 words)
The Vu c-POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c-POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c-POD Jntervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Integra Spine Manta Ray or the Integra Spine Tether systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101363: VU Cpod Intervertebral Bodu Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101363
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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