510(k) · Cleared
ClearedCuriteva Cervical Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curiteva, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 9, 2018 as substantially equivalent to K143578 (Globus Medical, Inc., 2016) and 2 other predicates after a 59-day review. Its family tree reaches back 16 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 9, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K003155 (2001). 150 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- This deviceK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- Descendant · cites it directly · 3 of its ownK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252205 Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK…Curiteva, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK254061 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240250 3D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- This deviceK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023 · cites it directly3descendants
- K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc. · 2026 · 2 generations on0descendants
- K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026 · 2 generations on0descendants
- K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −3 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −1 | K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 | — |
| 0 (this device) | K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018 | — |
| +1 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 | — |
| +2 | K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar… | Curiteva, Inc. | 2026 | — |
| +2 | K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026 | — |
| +2 | K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 23 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 12 | 0 |
| 2008 | 14 | 0 |
| 2009 | 10 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 4…ry: Globus Medical PATRIOT Cervical Spacers, (including s COLONIAL and COLONIAL TPS) -- K143578 Additional: DeGen Medical Latitude-C Cervical Interbody Spacer… | 2016 |
| * | K151496 | Latitude-C Cervical Interbody Spacer SystemSummary page 4…L and COLONIAL TPS) -- K143578 Additional: DeGen Medical Latitude-C Cervical Interbody Spacer System -- K151496 Additional: Titan Spine Endoskeleton TC -- K100889 C. Device Description The Curiteva Cervical… | 2015 |
| * | K100889 | Endoskeleton TCSummary page 4…dical Latitude-C Cervical Interbody Spacer System -- K151496 Additional: Titan Spine Endoskeleton TC -- K100889 C. Device Description The Curiteva Cervical Interbody Fusion System implants are available in a variety of different footprints… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | 2023 | 3 |
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 17 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 15 of the 150 ancestors have a recall of any class.
- Of its descendants, K213030 (Curiteva, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K143578.
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. 2018, 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 Curiteva Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 – T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft and/or allograft bone (comprised of…
Read the full statement (106 words)
The Curiteva Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 – T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181261: Curiteva Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181261
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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