510(k) · Cleared
ClearedCuriteva Porous PEEK Cervical Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curiteva, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 15, 2026 as substantially equivalent to K213030 (Curiteva, Inc., 2023) after a 29-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Jan 15, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K003155 (2001). 185 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- 2 generations backK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- 1 generation backK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- This deviceK254061 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 12 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 11 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 10 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 9 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 8 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 7 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 5 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 4 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 3 generations backK151496 Latitude-C Cervical Interbody Spacer SystemDegen Medical · 2015
- 2 generations backK181261 Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
- 1 generation backK213030 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023
- This deviceK254061 Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −12 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −11 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −8 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −7 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −5 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −4 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −3 | K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 | — |
| −2 | K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | 2018 | — |
| −1 | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2023 | — |
| 0 (this device) | K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 23 | 0 |
| 2005 | 11 | 0 |
| 2006 | 6 | 0 |
| 2007 | 12 | 0 |
| 2008 | 17 | 0 |
| 2009 | 13 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
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 |
|---|---|---|---|
| * | K213030 | Curiteva Porous PEEK Cervical Interbody Fusion SystemSummary page 5…1 CFR Part §888.3080) Classification Panel: Division of Orthopedic Devices Predicate Device: Curiteva Porous PEEK Cervical Interbody System (K213030) Reference Devices: Alphatec IdentiTi NanoTec Cervical Interbody System (K24137… | 2023 |
| † | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | 2025 |
| † | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 |
| † | K181261 | Curiteva Cervical Interbody Fusion System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 11 companies; a new generation was cleared every 11 months on median.
- 21 of the 185 ancestors have a recall of any class.
- 2 other devices also cite its predicate K213030.
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. 2026, 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 Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at…
Read the full statement (134 words)
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended to be used with supplemental fixation. The Curiteva Porous PEEK Cervical Interbody Fusion System is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254061 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254061: Curiteva Porous PEEK Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254061
Report an extraction error
Are you the manufacturer?
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