510(k) · Cleared
ClearedLatitude-C Cervical Interbody Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degen Medical · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 15, 2015 as substantially equivalent to K142152 (Orthofix, Inc., 2015) after a 195-day review. Its family tree reaches back 15 generations to 2001. 13 later devices descend from it.
- Decided
- Dec 15, 2015
- Review
- 195 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K003155 (2001). 90 ancestors in all, the oldest K841189 (1984). 13 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- Descendant · cites it directly · 4 of its ownK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- Descendant · cites it directly · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 1 generation backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- This deviceK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018 · cites it directly4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · cites it directly3descendants
- K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023 · 2 generations on3descendants
- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · 2 generations on2descendants
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 | — |
| +1 | K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018 | — |
| +1 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +2 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 | — |
| +2 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| +3 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemSummary page 4…mon Name Intervertebral body fusion device Code –Classification ODP 21 CFR 888.3080 : Class II Primary Predicate K142152 – CONSTRUX Mini PEEK Spacer System Reference Devices K133967 - Aurora Spine Interbody Fusion System… | 2015 |
| † | K133967 | Interbody Cage System | 2014 |
| † | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device | 2014 |
| † | K103488 | Concorde Bullet Cage System | 2011 |
| † | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | 2001 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181261 | Curiteva Cervical Interbody Fusion System | 2018 | 4 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | 2024 | 3 |
| K220296 | Manta Ray TDF Spacer | 2023 | 1 |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | 2025 | 0 |
| K251080 | IdentiTi II Cervical Interbody System | 2025 | 0 |
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 14 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 6 of the 90 ancestors have a recall of any class.
- Of its descendants, K181261 (Curiteva, LLC, 2018) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K142152.
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. 2015, 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?
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The Latitude-C Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or…
Read the full statement (104 words)
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Latitude-C Interbody Spacer is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151496: Latitude-C Cervical Interbody Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151496
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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