510(k) · Cleared
ClearedSeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 29, 2019 as substantially equivalent to K170569 (SeaSpine Orthopedics Corporation, 2017) and 1 other predicate after a 46-day review. Its family tree reaches back 17 generations to 2001. 74 later devices descend from it.
- Decided
- Apr 29, 2019
- Review
- 46 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K003155 (2001). 81 ancestors in all, the oldest K792352 (1979). 74 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- 2 generations backK161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016
- 1 generation backK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · cites it directly · 39 of its ownK210497 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · cites it directly · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · cites it directly · 20 of its ownK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
- Descendant · 2 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 7 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 6 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 4 generations backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- 3 generations backK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- 2 generations backK161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016
- 1 generation backK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- This deviceK190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2021 · cites it directly39descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 2 generations on28descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · cites it directly25descendants
- K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020 · cites it directly20descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −7 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −6 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| −4 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| −3 | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| −2 | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2016 | — |
| −1 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| 0 (this device) | K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2019 | — |
| +1 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +1 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +1 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | — |
| +2 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 16 | 0 |
| 2025 | 18 | 0 |
| 2026 | 13 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…Trade Name Manufacturer PRIMARY PREDICATE Device Shoreline™ ACS- Anterior SeaSpine Orthopedics K170569 OVE Cervical Standalone System Corporation… | 2017 |
| * | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…Corporation ADDITIONAL PREDICATE Shoreline™ ACS- Anterior SeaSpine Orthopedics K161081 OVE Cervical Standalone System Corporation Device Description… | 2016 |
What descends from it? (74)
See all 743 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 7 of the 81 ancestors have a recall of any class.
- Of its descendants, K210497 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 39 descendants of its own.
- 3 other devices also cite its predicate K170569.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The SeaSpine® Shoreline™ ACS is a stand-alone device indicated for anterior cervical interbody fusion procedures in
skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T1). The Shoreline™
ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or
corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had
at least six (6) weeks of non-operative treatment. The cervical device is to be used with bone screw fixation and a locking
cover.
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/K190655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190655
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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