510(k) · Cleared
ClearedF3D-C2 Cervical Stand-Alone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 4, 2022 as substantially equivalent to K200087 (Corelink, LLC, 2020) and 3 other predicates after a 273-day review. Its family tree reaches back 25 generations to 1984. 1 of the 496 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 4, 2022
- Review
- 273 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 25 generations to K841189 (1984). 492 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly. 1 of the 496 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- 2 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 1 generation backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- This deviceK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
- Descendant · cites it directly · 1 of its ownK251735 Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK254130 C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK230329 F3D Interbody SystemCorelink, LLC · 2023
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 7 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 6 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 5 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 4 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 3 generations backK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- 2 generations backK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- 1 generation backK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- This deviceK211417 F3D-C2 Cervical Stand-Alone SystemCorelink, LLC · 2022
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC · 2025 · cites it directly1descendant
- K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026 · 2 generations on0descendants
- K230329F3D Interbody SystemCorelink, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −7 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −6 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −5 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −4 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| −3 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| −2 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| −1 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| 0 (this device) | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | — |
| +1 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | — |
| +2 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026 | — |
| +1 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 16 | 0 |
| 2002 | 14 | 0 |
| 2003 | 21 | 0 |
| 2004 | 32 | 0 |
| 2005 | 27 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 55 | 1 |
| 2009 | 36 | 0 |
| 2010 | 23 | 0 |
| 2011 | 38 | 0 |
| 2012 | 26 | 0 |
| 2013 | 25 | 0 |
| 2014 | 26 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K200087 | F3D Cervical Stand-Alone Interbody Fusion SystemSummary page 5…Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Manufacturer Predicate Type Model Name K200087 F3D Cervical Stand-Alone CoreLink, LLC Primary Interbody Fixati… | 2020 |
| * | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Summary page 5…Model Name K200087 F3D Cervical Stand-Alone CoreLink, LLC Primary Interbody Fixation System K173115 MIS COALITION® Spacers Globus Medical Additional K152793 Unison-C Ante… | 2017 |
| * | K152793 | Unison-C Anterior Cervical Fixation SystemSummary page 5…C Primary Interbody Fixation System K173115 MIS COALITION® Spacers Globus Medical Additional K152793 Unison-C Anterior Cervical RTI Surgical, Inc. Additional Fixation Syst… | 2016 |
| * | K191489 | Genesys Spine 3DP Cervical Interbody SystemSummary page 5…s Medical Additional K152793 Unison-C Anterior Cervical RTI Surgical, Inc. Additional Fixation System K191489 Genesys Spine 3DP Cervical Genesys Spine Additional Interbody Sys… | 2020 |
What descends from it? (3)
2 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 38 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 61 of the 492 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251735 (Acuity Surgical Devices, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K200087.
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. 2022, 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 F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone…
Read the full statement (230 words)
The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.
The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211417: F3D-C2 Cervical Stand-Alone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211417
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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