510(k) · Cleared
ClearedSeaSpine Cambria 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 Jul 7, 2017 as substantially equivalent to K082309 (Seaspine, Inc., 2009) and 3 other predicates after a 91-day review. Its family tree reaches back 16 generations to 1984. 62 later devices descend from it.
- Decided
- Jul 7, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 145 ancestors in all. 62 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- This deviceK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 61 of its ownK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- Descendant · cites it directly · 60 of its ownK183083 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 · 2 generations on · 20 of its ownK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- This deviceK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017 · cites it directly61descendants
- K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · cites it directly60descendants
- 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 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −1 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| 0 (this device) | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
| +1 | 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 | — |
| +2 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 12 | 0 |
| 2008 | 21 | 0 |
| 2009 | 12 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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.
Planning a device in ODP? 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? (4)
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 |
|---|---|---|---|
| * | K082309 | CambriaSummary page 5…Trade Name Manufacturer PRIMARY PREDICATE Device SeaSpine K082309 ODP Cambria System Orthopedics… | 2009 |
| * | K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…Summary page 5…Corporation Additional PREDICATE Devices SeaSpine K162715 ODP Cambria NanoMetalene Sterile Orthopedics… | 2016 |
| * | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Summary page 5…Corporation SeaSpine K142488 ODP Cambria NanoMetalene Orthopedics… | 2014 |
| * | K151322 | Amendia Interbody Fusion DevicesSummary page 5…Orthopedics Corporation Zeus-C-Amendia Interbody K151322 MAX, ODP Amendia, Inc. Fusion… | 2015 |
What descends from it? (62)
See all 624 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | 2017 | 61 |
| K183083 | Shoreline Cervical Interbody RT System | 2019 | 60 |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | 2021 | 39 |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | 2020 | 18 |
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 33 years and passes through 13 companies; a new generation was cleared every 1.7 years on median.
- 20 of the 145 ancestors have a recall of any class.
- Of its descendants, K172926 (SeaSpine Orthopedics Corporation, 2017) has gone furthest, with 61 descendants of its own.
- 2 other devices also cite its predicate K082309.
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. 2017, 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?
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (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…
Read the full statement (209 words)
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171046: SeaSpine Cambria System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171046
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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