510(k) · Cleared
ClearedSeaSpine Vu cPOD, Zuma-C, Complete Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 21, 2017 as substantially equivalent to K171046 (SeaSpine Orthopedics Corporation, 2017) and 6 other predicates after an 87-day review. Its family tree reaches back 17 generations to 1984. 1 of the 244 devices in its family, counting itself, has a Class I recall. 61 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K841189 (1984). 182 ancestors in all, the oldest K792352 (1979). 61 later devices descend from it, 1 citing it directly. 1 of the 244 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 1 generation backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK172926 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
- Descendant · 2 generations on · 20 of its ownK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 18 of its ownK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 4 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 1 generation backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 61 · See all- 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
- K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020 · 2 generations on20descendants
- K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2020 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −4 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −2 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| −1 | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| 0 (this device) | 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 | — |
| +2 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 18 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 13 | 0 |
| 2008 | 30 | 1 |
| 2009 | 16 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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? (7)
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 |
|---|---|---|---|
| * | K171046 | SeaSpine Cambria SystemSummary page 6…ode: ODP, OVE Legally Marketed Predicate Devices 510(k) Number Product Code Trade Name Manufacturer PRIMARY PREDICATE Device K171046 ODP Cambria System SeaSpine Orthopedics Corporation Additional PREDICATE Devices… | 2017 |
| * | K111675 | VU C*Pod Intervertebral Body Fusion DeviceSummary page 6…ia System SeaSpine Orthopedics Corporation Additional PREDICATE Devices SeaSpine Orthopedics Corporation K111675,K101363, (originally manufactured by Integra ODP… | 2011 |
| * | K101363 | VU Cpod Intervertebral Bodu Fusion DeviceSummary page 6…m SeaSpine Orthopedics Corporation Additional PREDICATE Devices SeaSpine Orthopedics Corporation K111675,K101363, (originally manufactured by Integra ODP Vu c·POD… | 2010 |
| * | K050058 | Theken Reveal VBR SystemSummary page 6…Orthopedics Corporation K111675,K101363, (originally manufactured by Integra ODP Vu c·POD K050058, K032064 LifeSciences, now SeaSpine… | 2005 |
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 6…cs Corporation K111675,K101363, (originally manufactured by Integra ODP Vu c·POD K050058, K032064 LifeSciences, now SeaSpine… | 2004 |
| * | K102323 | Cervical Standalone Intervertebral Body Fusion DeviceSummary page 6…SeaSpine Orthopedics Corporation (originally manufactured by Theken, K102323 ODP Complete Cervical LLC, now SeaSpine Ortho… | 2010 |
| * | K092521 | ZUMA-CSummary page 6…Corporation) SeaSpine Orthopedics Corporation K092521 ODP Zuma-C… | 2010 |
What descends from it? (61)
See all 611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183083 | Shoreline Cervical Interbody RT System | 2019 | 60 |
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 22 of the 182 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183083 (SeaSpine Orthopedics Corporation, 2019) has gone furthest, with 60 descendants of its own.
- 3 other devices also cite its predicate K171046.
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. 2017, 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 and radiographic studies. The Vu c•POD implants are to be used with autograft bone graft and/or allogeneic…
Read the full statement (340 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 and radiographic studies.
The Vu c•POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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 Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems.
Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.
The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Complete Cervical implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172926
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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