510(k) · Cleared
Clearedaprevo® cervical interbody system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carlsmed, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 6, 2026 as substantially equivalent to K250827 (Carlsmed, Inc., 2025) and 1 other predicate after a 117-day review. Its family tree reaches back 34 generations to 1984. 4 of the 1,445 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 6, 2026
- Review
- 117 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 34 generations to K841189 (1984). 1,443 ancestors in all, the oldest K761228 (1976). 1 later device descends from it, 1 citing it directly. 4 of the 1,445 devices in this family, counting this one, have a Class I recall.
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations between
- 3 generations backK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
- 2 generations backK243802 aprevo® anterior and lateral lumbar interbody fusion device, aprevo®…Carlsmed, Inc. · 2025
- 1 generation backK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- This deviceK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 34 generations
- Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 33 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 32 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 31 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 30 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 28 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 27 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 26 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 24 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 23 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 22 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 21 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 20 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 19 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 18 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 17 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 16 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 15 generations backK160955 Tritanium® PL CageStryker · 2016
- 14 generations backK162262 Tritanium® PL CageStryker · 2016
- 13 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 12 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 11 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 10 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 8 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 7 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 6 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 5 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 4 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 3 generations backK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
- 2 generations backK243802 aprevo® anterior and lateral lumbar interbody fusion device, aprevo®…Carlsmed, Inc. · 2025
- 1 generation backK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- This deviceK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −34 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −33 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −32 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −31 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −30 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −28 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −27 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −26 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −24 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −23 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −22 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −21 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −20 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −19 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −18 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −17 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −16 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −15 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −14 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −12 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −11 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −10 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −9 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −8 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −7 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −6 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −5 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| −3 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | — |
| −2 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior… | Carlsmed, Inc. | 2025 | — |
| −1 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| 0 (this device) | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +1 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 3 | 0 |
| 1988 | 3 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 12 | 0 |
| 1993 | 10 | 0 |
| 1994 | 17 | 0 |
| 1995 | 25 | 0 |
| 1996 | 29 | 0 |
| 1997 | 22 | 0 |
| 1998 | 38 | 0 |
| 1999 | 31 | 0 |
| 2000 | 44 | 0 |
| 2001 | 55 | 0 |
| 2002 | 49 | 0 |
| 2003 | 59 | 0 |
| 2004 | 81 | 0 |
| 2005 | 68 | 0 |
| 2006 | 53 | 0 |
| 2007 | 47 | 0 |
| 2008 | 96 | 1 |
| 2009 | 69 | 0 |
| 2010 | 63 | 1 |
| 2011 | 84 | 0 |
| 2012 | 53 | 0 |
| 2013 | 57 | 0 |
| 2014 | 62 | 0 |
| 2015 | 57 | 1 |
| 2016 | 51 | 1 |
| 2017 | 49 | 0 |
| 2018 | 24 | 0 |
| 2019 | 22 | 0 |
| 2020 | 21 | 0 |
| 2021 | 11 | 0 |
| 2022 | 8 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 devices in this family have 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 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? (2)
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 |
|---|---|---|---|
| * | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Summary page 5…ystem, aprevo® anterior lumbar interbody fusion device, aprevo® lateral ODP, OVE, lumbar interbody fusion device, aprevo® anterior K250827 Carlsmed, Inc. MAX, OVD lumbar interbody fusion de… | 2025 |
| * | K241846 | E3D™-C Interbody SystemSummary page 5…aprevo® transforaminal lumbar interbody fusion device, aprevo® TLIF-CA Ar cula ng System Addi onal Predicate Device K241846 OVE, ODP E3D™-C Interbody System Evolu on Spine… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | 2026 | 0 |
Has anything in its family been recalled? (4 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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 8 months on median.
- 163 of the 1,443 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K260385 (Carlsmed, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K250827.
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 aprevo® cervical ACDF interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history…
Read the full statement (273 words)
The aprevo® cervical ACDF interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The aprevo® cervical ACDF interbody system must be used with supplemental fixation (e.g., cervical plate or cervical posterior fixation).
The aprevo® cervical ACDF-X interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. When used with the screws that accompany the device, the aprevo® cervical ACDF-X interbody system is intended for use as a standalone system. Deformity procedures to correct coronal angulation or use of a hyperlordotic device (>20° lordosis) must include supplemental fixation (e.g., cervical plate or cervical posterior fixation).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252894: aprevo® cervical interbody system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252894
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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