510(k) · Cleared
ClearedShoreline Cervical Interbody RT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Feb 14, 2019 as substantially equivalent to K170569 (SeaSpine Orthopedics Corporation, 2017) and 9 other predicates after a 100-day review. Its family tree reaches back 18 generations to 1984. 1 of the 320 devices in its family, counting itself, has a Class I recall. 60 later devices descend from it.
- Decided
- Feb 14, 2019
- Review
- 100 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 18 generations to K841189 (1984). 259 ancestors in all, the oldest K792352 (1979). 60 later devices descend from it, 6 citing it directly. 1 of the 320 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 2 generations backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- 1 generation backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- This deviceK183083 Shoreline Cervical Interbody RT 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 · 20 of its ownK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 18 of its ownK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 17 of its ownK201073 Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2020
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 5 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 4 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 3 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 2 generations backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- 1 generation backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- This deviceK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 60 · 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
- K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020 · cites it directly20descendants
- K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation · 2020 · cites it directly18descendants
- K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2020 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −5 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −3 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| −2 | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| −1 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
| 0 (this device) | K183083 | Shoreline Cervical Interbody RT 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 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 35 | 1 |
| 2009 | 24 | 0 |
| 2010 | 16 | 0 |
| 2011 | 18 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 11 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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…DICATE Device Shoreline ACS- SeaSpine Orthopedics K170569 OVE Anterior Cervical Corporation… | 2017 |
| * | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…dicate Device Shoreline ACS- SeaSpine Orthopedics K161081 OVE Anterior Cervical Corporation… | 2016 |
| * | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…Summary page 4…Corporation System Cambria SeaSpine Orthopedics K162715, K171046 ODP, MAX NanoMetalene Sterile Corporation… | 2016 |
| * | K171046 | SeaSpine Cambria SystemSummary page 4…Corporation System Cambria SeaSpine Orthopedics K162715, K171046 ODP, MAX NanoMetalene Sterile Corporation… | 2017 |
| * | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete CervicalSummary page 4…NanoMetalene Sterile Corporation SeaSpine Orthopedics K172926, K111675, Corporation K101363, K050058, ODP, OVE Vu c·PO… | 2017 |
| * | K111675 | VU C*Pod Intervertebral Body Fusion DeviceSummary page 4…NanoMetalene Sterile Corporation SeaSpine Orthopedics K172926, K111675, Corporation K101363, K050058, ODP, OVE Vu c·POD… | 2011 |
| * | K101363 | VU Cpod Intervertebral Bodu Fusion DeviceSummary page 4…SeaSpine Orthopedics K172926, K111675, Corporation K101363, K050058, ODP, OVE Vu c·POD (originally manufactured by… | 2010 |
| * | K050058 | Theken Reveal VBR SystemSummary page 4…SeaSpine Orthopedics K172926, K111675, Corporation K101363, K050058, ODP, OVE Vu c·POD (originally manufactured by… | 2005 |
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 4…ODP, OVE Vu c·POD (originally manufactured by Integra LifeSciences, now K032064 SeaSpine Orthopedics… | 2004 |
| * | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN SpacerSummary page 5…K183083- Page 2 of 3 Patriot Colonial K173722 ODP Globus Medical Inc. Spacer… | 2018 |
What descends from it? (60)
See all 606 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | 2021 | 39 |
| K201646 | Shoreline ACS (Anterior Cervical System) | 2020 | 20 |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | 2020 | 18 |
| K201073 | Seaspine WaveForm C Interbody System | 2020 | 17 |
| K213359 | SeaSpine WaveForm, C Interbody System | 2021 | 7 |
| K220296 | Manta Ray TDF Spacer | 2023 | 1 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
- 29 of the 259 ancestors have a recall of any class; 1 has a Class I recall.
- 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 ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative…
Read the full statement (203 words)
The Shoreline Cervical Interbody RT System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
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/K183083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183083: Shoreline Cervical Interbody RT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183083
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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