510(k) · Cleared
ClearedIN:C2 Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Smith Partners L.P. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 5, 2012 as substantially equivalent to K080971 (Spine Smith Partners L.P., 2008) and 2 other predicates after a 99-day review. Its family tree reaches back 8 generations to 1984. 405 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 30 ancestors in all. 405 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 2 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 1 generation backK080971 Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008
- This deviceK122630 IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
- Descendant · cites it directly · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 3 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · cites it directly · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
- Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 405 · See all- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · cites it directly330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 3 generations on169descendants
- K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · cites it directly155descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −1 | K080971 | Spinesmith Cimplicity Spinal System | Spine Smith Partners L.P. | 2008 | — |
| 0 (this device) | K122630 | IN:C2 Spinal Fixation System | Spine Smith Partners L.P. | 2012 | — |
| +1 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +1 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
| +2 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 17 | 0 |
| 2018 | 15 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 38 | 0 |
| 2022 | 50 | 0 |
| 2023 | 55 | 0 |
| 2024 | 52 | 0 |
| 2025 | 52 | 0 |
| 2026 | 48 | 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 OVE? 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? (3)
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 |
|---|---|---|---|
| * | K080971 | Spinesmith Cimplicity Spinal SystemSummary page 1…ation System IDENTIFICATION OF PREDICATE DEVICES: The SpineSmith IN:C2 System was determined to be substantially equivalent to the previously cleared Cimplicity System (K080971) as well as the Coalition Spacer (K(083389) and the InterPlate C-Ti (K092070). DEVICE DESCRIPTION: SpineSmith Partners LLP devel… | 2008 |
| * | K083389 | Coalition SpacerSummary page 1…VICES: The SpineSmith IN:C2 System was determined to be substantially equivalent to the previously cleared Cimplicity System (K080971) as well as the Coalition Spacer (K(083389) and the InterPlate C-Ti (K092070). DEVICE DESCRIPTION: SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be… | 2009 |
| * | K092070 | Interplate CSummary page 1…m was determined to be substantially equivalent to the previously cleared Cimplicity System (K080971) as well as the Coalition Spacer (K(083389) and the InterPlate C-Ti (K092070). DEVICE DESCRIPTION: SpineSmith Partners LLP developed the IN:C2 Spinal Fixation System to be used during spinal fusion. IN:C2… | 2009 |
What descends from it? (405)
See all 4055 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K133494 (K2m, Inc., 2014) has gone furthest, with 330 descendants of its own.
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. 2012, 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 IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic…
Read the full statement (134 words)
The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122630: IN:C2 Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122630
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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