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 Dec 9, 2021 as substantially equivalent to K201073 (SeaSpine Orthopedics Corporation, 2020) and 6 other predicates after a 58-day review. Its family tree reaches back 26 generations to 1984. 1 of the 557 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Dec 9, 2021
- Review
- 58 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 26 generations to K841189 (1984). 549 ancestors in all, the oldest K792352 (1979). 7 later devices descend from it, 3 citing it directly. 1 of the 557 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 1 generation backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- This deviceK213359 SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · cites it directly · 3 of its ownK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- Descendant · cites it directly · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK250987 aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 8 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 7 generations backK160955 Tritanium® PL CageStryker · 2016
- 6 generations backK162262 Tritanium® PL CageStryker · 2016
- 5 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 4 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 3 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 2 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 1 generation backK211258 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System…Medtronic Sofamor Danek USA, Inc. · 2021
- This deviceK213359 SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation · 2021
Showing 5 of 7 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 7 · See all- K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation · 2024 · cites it directly3descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · cites it directly2descendants
- K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025 · 2 generations on1descendant
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 2 generations on0descendants
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −8 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −7 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −6 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −5 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −4 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −3 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −2 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −1 | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System… | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| 0 (this device) | K213359 | SeaSpine WaveForm, C Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| +1 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral… | SeaSpine Orthopedics Corporation | 2024 | — |
| +1 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +2 | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025 | — |
| +2 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
| +3 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | — |
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 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 19 | 0 |
| 2004 | 29 | 0 |
| 2005 | 23 | 0 |
| 2006 | 15 | 0 |
| 2007 | 20 | 0 |
| 2008 | 53 | 1 |
| 2009 | 42 | 0 |
| 2010 | 32 | 0 |
| 2011 | 48 | 0 |
| 2012 | 32 | 0 |
| 2013 | 31 | 0 |
| 2014 | 39 | 0 |
| 2015 | 31 | 0 |
| 2016 | 26 | 0 |
| 2017 | 23 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K201073 | Seaspine WaveForm C Interbody SystemSummary page 4…rade Name Manufacturer Primary Predicate Device SeaSpine WaveForm™ C SeaSpine Orthopedics K201073 OVE, ODP Interbody System Corporation Additional Predi… | 2020 |
| * | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSummary page 4…dy System Corporation Additional Predicate Device SeaSpine Orthopedics K161081 OVE SeaSpine Shoreline ACS System… | 2016 |
| * | K183083 | Shoreline Cervical Interbody RT SystemSummary page 4…K161081 OVE SeaSpine Shoreline ACS System Corporation K183083 OVE, ODP Shoreline Cervical Interbody RT SeaSpine Orthopedics… | 2019 |
| * | K172676 | NuVasive® Modulus-C Interbody SystemSummary page 5…Product Code Trade Name Manufacturer NuVasive, K172676 ODP NuVasive Modulus-C Interbody… | 2017 |
| * | K192582 | NuVasive CoRoent Small Interlock SystemSummary page 5…K172676 ODP NuVasive Modulus-C Interbody Incorporated K192582 NuVasive CoRoent Small NuVasive, OVE… | 2019 |
| * | K172064 | Ti-Diagon Oblique TLIFSummary page 5…Interlock System Incorporated Camber Spine K172064 MAX Ti-Diagon Oblique TLIF… | 2017 |
| * | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Summary page 5…Endoskeleton TAS & TAS Hyp MAX, ODP, Medtronic Sofamor K211258 Interbody System, Endoskeleton OVD, OVE… | 2021 |
What descends from it? (7)
3 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 37 years and passes through 16 companies; a new generation was cleared every 9 months on median.
- 59 of the 549 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241466 (SeaSpine Orthopedics Corporation, 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K201073.
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. 2021, 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 patient with degenerative disc disease (DDD) of the cervical spine (C2-Tl) for multiple contiguous levels. 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…
Read the full statement (187 words)
The SeaSpine Waveform™ C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-Tl) for multiple contiguous levels. 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, which includes the 2,3,4 hole TruProfile plates and 2-hole No-Profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-Tl ), and must be used with bone screw fixation and locking covers.
When the Waveform™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is 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 multiple contiguous levels of the cervical spine (C2-Tl).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213359: 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/K213359
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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