510(k) · Cleared
ClearedSeaSpine Ventura NanoMetalene System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 26, 2017 as substantially equivalent to K162715 (SeaSpine Orthopedics Corporation, 2016) and 3 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Oct 26, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K841189 (1984). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- 2 generations backK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- 1 generation backK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
- This deviceK173022 SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation · 2017
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 backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 4 generations backK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- 3 generations backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- 2 generations backK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- 1 generation backK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
- This deviceK173022 SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation · 2017
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 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −4 | K071031 | VU E*Pod Vertebral Body Replacement | Theken Spine, LLC | 2007 | — |
| −3 | 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 | — |
| −1 | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene… | SeaSpine Orthopedics Corporation | 2016 | — |
| 0 (this device) | K173022 | SeaSpine Ventura NanoMetalene System | SeaSpine Orthopedics Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…Summary page 4…ce SeaSpine SeaSpine Ventura K162715 MAX Orthopedics Nano… | 2016 |
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 4…Corporation Additional PREDICATE Devices SeaSpine Spacer System- SeaSpine K142488 MAX NanoMetalene Orthopedics Ve… | 2014 |
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 4…SeaSpine SeaSpine Spacer System- K082310 MAX Orthopedics Ve… | 2008 |
| * | K102026 | Seaspine Spacer SystemSummary page 4…SeaSpine SeaSpine Spacer System- K102026 MAX Orthopedics… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 4 other devices also cite its predicate K162715.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2‐S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may…
Read the full statement (108 words)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2‐S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non‐fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non‐operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173022: SeaSpine Ventura NanoMetalene System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173022
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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