510(k) · Cleared
ClearedRedondo-L
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 Jan 27, 2011 as substantially equivalent to K082310 (Seaspine, Inc., 2008) after an 80-day review. Its family tree reaches back 1 generation to 2008. 117 later devices descend from it.
- Decided
- Jan 27, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082310 (2008). 117 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK082310 Hollywood, Pacifica, Redondo, VenturaSeaspine, Inc. · 2008
- This deviceK103297 Redondo-LSeaspine, Inc. · 2011
- Descendant · cites it directly · 116 of its ownK142488 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)…Seaspine, Inc. · 2014
- Descendant · 2 generations on · 103 of its ownK162715 SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI…SeaSpine Orthopedics Corporation · 2016
- Descendant · 3 generations on · 82 of its ownK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 79 of its ownK162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion…SeaSpine Orthopedics Corporation · 2016
- Descendant · 4 generations on · 74 of its ownK190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc. · 2014 · cites it directly116descendants
- K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation · 2016 · 2 generations on103descendants
- K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017 · 3 generations on82descendants
- K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation · 2016 · 2 generations on79descendants
- K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019 · 4 generations on74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082310 | Hollywood, Pacifica, Redondo, Ventura | Seaspine, Inc. | 2008 | — |
| 0 (this device) | K103297 | Redondo-L | Seaspine, Inc. | 2011 | — |
| +1 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene… | Seaspine, Inc. | 2014 | — |
| +2 | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene… | SeaSpine Orthopedics Corporation | 2016 | — |
| +3 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K162351 | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016 | — |
| +4 | K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 21 | 0 |
| 2026 | 15 | 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? (1)
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 |
|---|---|---|---|
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 1…uct Code MAX, Class 11) (Orthopedic Review Committee) Predicate Device: Previously cleared SeaSpine Spacer System 510(k) (1(082310) m Device Description:… | 2008 |
What descends from it? (117)
See all 1171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria… | 2014 | 116 |
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?
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. 2011, 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 proceddres at one or two contiguous levels (12-Si) in skeletally mature patients with degenerative disc disease (DDD). DOD isdefined 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 proceddres at one or two contiguous levels (12-Si) in skeletally mature patients with degenerative disc disease (DDD). DOD isdefined 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 avertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (TI to 15) 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 biomnechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103297: Redondo-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103297
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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