510(k) · Cleared
ClearedSeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 1, 2016 as substantially equivalent to K121211 (Theken Spine, LLC, 2012) and 2 other predicates after a 100-day review. Its family tree reaches back 18 generations to 1984. 79 later devices descend from it.
- Decided
- Dec 1, 2016
- Review
- 100 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 288 ancestors in all, the oldest K792352 (1979). 79 later devices descend from it, 5 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- This deviceK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 63 of its ownK181079 SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · cites it directly · 60 of its ownK200879 SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 59 of its ownK192132 SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · Recalled
- Descendant · cites it directly · 59 of its ownK173606 SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2018
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 5 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 4 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 3 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 2 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 1 generation backK161379 ELSA SpacersGlobus Medical, Inc. · 2016
- This deviceK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · cites it directly67descendants
- K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2018 · cites it directly63descendants
- K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 2020 · cites it directly60descendants
- K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on59descendants
- K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation · 2018 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −5 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −3 | 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 | — |
| −1 | K161379 | ELSA Spacers | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018 | — |
| +1 | K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019 | 1 |
| +1 | K173606 | SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device… | SeaSpine Orthopedics Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 19 | 0 |
| 2004 | 37 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 17 | 0 |
| 2008 | 35 | 0 |
| 2009 | 20 | 0 |
| 2010 | 15 | 0 |
| 2011 | 18 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K121211 | VU Apod Intervertebral Body Fusion DeviceSummary page 5…roduct Trade Name Manufacturer Code PRIMARY PREDICATE Device Vu a•POD™ Intervertebral K121211 OVD SeaSpine® Orthopedics Corp. Body Fusion Device Pr… | 2012 |
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 5…ody Fusion Device Predicate Devices Vu a•POD-L™ SeaSpine® Orthopedics Corp. K142488 MAX Intervertebral Body Fusion Device NanoMetalene® K161379 OVD, MAX… | 2014 |
| * | K161379 | ELSA Spacers Cleared while this submission was under review Summary page 5…SeaSpine® Orthopedics Corp. K142488 MAX Intervertebral Body Fusion Device NanoMetalene® K161379 OVD, MAX ELSA™ Spacers Globus Medical, Inc.… | 2016 |
What descends from it? (79)
See all 795 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica… | 2017 | 67 |
| K181079 | SeaSpine Regatta Lateral System | 2018 | 63 |
| 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 |
| K211837 | Altus Spine Interbody Standalone Fusion System | 2022 | 0 |
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 32 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 27 of the 288 ancestors have a recall of any class.
- Of its descendants, K173260 (SeaSpine Orthopedics Corporation, 2017) has gone furthest, with 67 descendants of its own.
- 5 other devices also cite its predicate K121211.
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. 2016, 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 SeaSpine® Vu a•POD™ Prime NanoMetalene® 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…
Read the full statement (356 words)
When used with the bone screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® 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 interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® 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 interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a•POD™ Prime NanoMetalene® 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. Additionally, implants with hyperlordotic angles of >20ࡈ must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
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/K162351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® 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/K162351
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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