510(k) · Cleared
ClearedHollywood, Pacifica, Redondo, Ventura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 10, 2008 after an 89-day review. The FDA summary names no predicate by number. 1 of the 646 devices in its family, counting itself, has a Class I recall. 645 later devices descend from it.
- Decided
- Nov 10, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
645 later devices descend from it, 18 citing it directly. 1 of the 646 devices in this family, counting this one, has a Class I recall.
- This deviceK082310 Hollywood, Pacifica, Redondo, VenturaSeaspine, Inc. · 2008
- Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 4 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
Showing 5 of 645 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 645 · See all- K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 4 generations on400descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082310 | Hollywood, Pacifica, Redondo, Ventura | Seaspine, Inc. | 2008 | — |
| +1 | K131082 | Interform Interbody Cage System | Next Orthosurgical | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +4 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 11 | 0 |
| 2016 | 21 | 0 |
| 2017 | 35 | 0 |
| 2018 | 38 | 0 |
| 2019 | 52 | 0 |
| 2020 | 68 | 0 |
| 2021 | 54 | 1 |
| 2022 | 63 | 0 |
| 2023 | 76 | 0 |
| 2024 | 85 | 0 |
| 2025 | 73 | 0 |
| 2026 | 60 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (645)
See all 64518 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K122639 | Synthes Syncage Evolution Spacer | 2013 | 143 |
| K103297 | Redondo-L | 2011 | 117 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria… | 2014 | 116 |
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica… | 2017 | 67 |
| K192132 | SeaSpine Beachside System | 2019 | 59 |
| K193636 | SeaSpine Reef TH System | 2020 | 56 |
| K152512 | Half Dome Posterior Lumbar Interbody System | 2016 | 33 |
| K162206 | Zavation IBF | 2017 | 24 |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | 2020 | 17 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K131082 (Next Orthosurgical, 2013) has gone furthest, with 595 descendants of its own.
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. 2008, 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 SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-Si) 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).…
Read the full statement (211 words)
When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-Si) 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 and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082310: Hollywood, Pacifica, Redondo, Ventura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082310
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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