510(k) · Cleared
ClearedSeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
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 28, 2016 as substantially equivalent to K102026 (Seaspine, Inc., 2011) and 1 other predicate after a 29-day review. Its family tree reaches back 10 generations to 1984. 103 later devices descend from it.
- Decided
- Oct 28, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K841189 (1984). 22 ancestors in all. 103 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- 2 generations backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- 1 generation backK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- This deviceK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 82 of its ownK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 74 of its ownK190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · cites it directly · 67 of its ownK173260 SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI…SeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 62 of its ownK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 61 of its ownK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK050058 Theken Reveal VBR SystemTheken Surgical,Llc · 2005
- 3 generations backK071031 VU E*Pod Vertebral Body ReplacementTheken Spine, LLC · 2007
- 2 generations backK082712 Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC · 2009
- 1 generation backK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- This deviceK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017 · cites it directly82descendants
- K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on74descendants
- K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation · 2017 · cites it directly67descendants
- K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017 · cites it directly62descendants
- K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017 · 2 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K050058 | Theken Reveal VBR System | Theken Surgical,Llc | 2005 | — |
| −3 | K071031 | VU E*Pod Vertebral Body Replacement | Theken Spine, LLC | 2007 | — |
| −2 | K082712 | Theken Spine VU Epod and VU Lpod System | Theken Spine, LLC | 2009 | — |
| −1 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene… | Seaspine, Inc. | 2014 | — |
| 0 (this device) | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene… | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2019 | — |
| +1 | K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura… | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 18 | 0 |
| 2024 | 18 | 0 |
| 2025 | 19 | 0 |
| 2026 | 14 | 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? (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 |
|---|---|---|---|
| * | K102026 | Seaspine Spacer SystemSummary page 5…tebral body fusion device (21 CFR 888.3080) MAX, ODP Legally Marketed Predicate Devices 510(k) Number | Product Code Trade Name Manufacturer Primary Predicate Device K102026 MAX, MQP SeaSpine® Spacer System- SeaSpine® Orthopedics (Hollywood NanoMetalene®) Corporation Predicate Device K142488 MAX, ODP S… | 2011 |
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 5…e Trade Name Manufacturer Primary Predicate Device K102026 MAX, MQP SeaSpine® Spacer System- SeaSpine® Orthopedics (Hollywood NanoMetalene®) Corporation Predicate Device K142488 MAX, ODP SeaSpine® Spacer System SeaSpine® Orthopedics (Hollywood VI NanoMetalene®, Ventura NanoMetalene®) and Cambria NanoMetal… | 2014 |
What descends from it? (103)
See all 1035 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | 2017 | 82 |
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica… | 2017 | 67 |
| K171046 | SeaSpine Cambria System | 2017 | 62 |
| K183083 | Shoreline Cervical Interbody RT System | 2019 | 60 |
| K173022 | SeaSpine Ventura NanoMetalene System | 2017 | 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 9 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K170569 (SeaSpine Orthopedics Corporation, 2017) has gone furthest, with 82 descendants of its own.
- 4 other devices also cite its predicate K102026.
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. 2016, 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?
SeaSpine® Spacer System – Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®: 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…
Read the full statement (209 words)
SeaSpine® Spacer System – Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®:
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.
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3‐C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non‐operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162715
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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