510(k) · Cleared
ClearedSeaspine WaveForm C Interbody 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 Sep 18, 2020 as substantially equivalent to K161081 (SeaSpine Orthopedics Corporation, 2016) and 3 other predicates after a 149-day review. Its family tree reaches back 19 generations to 1984. 1 of the 316 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Sep 18, 2020
- Review
- 149 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 298 ancestors in all, the oldest K792352 (1979). 17 later devices descend from it, 2 citing it directly. 1 of the 316 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- 2 generations backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- 1 generation backK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- This deviceK201073 Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2020
- Descendant · cites it directly · 15 of its ownK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 8 of its ownK233414 Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023
- Descendant · cites it directly · 7 of its ownK213359 SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 2 generations on · 5 of its ownK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
- Descendant · 3 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 6 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 5 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 4 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 3 generations backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- 2 generations backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- 1 generation backK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- This deviceK201073 Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 17 · See all- K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly15descendants
- K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation · 2023 · 2 generations on8descendants
- K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly7descendants
- K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022 · 2 generations on5descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −6 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −5 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −4 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| −3 | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| −2 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
| −1 | K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 | — |
| 0 (this device) | K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2020 | — |
| +1 | K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | 2023 | — |
| +1 | K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| +2 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | — |
| +3 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 24 | 0 |
| 2005 | 15 | 0 |
| 2006 | 12 | 0 |
| 2007 | 17 | 0 |
| 2008 | 37 | 1 |
| 2009 | 25 | 0 |
| 2010 | 17 | 0 |
| 2011 | 21 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 14 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…SeaSpine Shoreline ACS – SeaSpine Orthopedics K161081 OVE Anterior Cervical Standalone Corporation Syste… | 2016 |
| * | K151939 | COALITION SpacersSummary page 4…al Standalone Corporation System Additional Predicate Devices OVE, ODP, K151939 Coalition Spacers Globus Medical, Inc. KWQ… | 2016 |
| * | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Summary page 4…K151939 Coalition Spacers Globus Medical, Inc. KWQ ODP, KWQ, K173115 Coalition Spacers Globus Medical, Inc. OVE… | 2017 |
| * | K183083 | Shoreline Cervical Interbody RT SystemSummary page 4…s Globus Medical, Inc. OVE Shoreline Cervical Interbody RT SeaSpine Orthopedics K183083 ODP, OVE System Corporation… | 2019 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
- 33 of the 298 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212904 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K161081.
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. 2020, 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 WaveForm™ C Interbody 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 (181 words)
The SeaSpine WaveForm™ C Interbody 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 and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, 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 bone screw fixation and locking covers.
When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).
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/K201073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201073: Seaspine WaveForm C Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201073
Report an extraction error
Are you the manufacturer?
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