510(k) · Cleared
Clearedaprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
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 Nov 15, 2024 as substantially equivalent to K222973 (Alphatec Spine, Inc., 2022) and 9 other predicates after a 107-day review. Its family tree reaches back 31 generations to 1984. 2 of the 1,162 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Nov 15, 2024
- Review
- 107 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 31 generations to K841189 (1984). 1,158 ancestors in all, the oldest K761228 (1976). 3 later devices descend from it, 1 citing it directly. 2 of the 1,162 devices in this family, counting this one, have a Class I recall.
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations between
- 3 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 2 generations backK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- 1 generation backK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
- This deviceK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK250827 aprevo® anterior lumbar interbody fusion device; aprevo® lateral…Carlsmed, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK252894 aprevo® cervical interbody systemCarlsmed, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 31 generations
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 29 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 28 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 25 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 24 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 21 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 20 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 19 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 18 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 17 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 16 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 15 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 14 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 13 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 12 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 11 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 10 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 8 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 7 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 6 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 5 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 4 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 3 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 2 generations backK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- 1 generation backK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
- This deviceK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc. · 2025 · cites it directly2descendants
- K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026 · 2 generations on1descendant
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −30 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −29 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −28 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −25 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −24 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −21 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −20 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −19 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −18 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −17 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −16 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −15 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −14 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −13 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −12 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −11 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −10 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −8 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −7 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −5 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −4 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −3 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −2 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| −1 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
| 0 (this device) | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
| +1 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar… | Carlsmed, Inc. | 2025 | — |
| +2 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | — |
| +2 | 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 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 9 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 14 | 0 |
| 1996 | 22 | 0 |
| 1997 | 16 | 0 |
| 1998 | 30 | 0 |
| 1999 | 21 | 0 |
| 2000 | 31 | 0 |
| 2001 | 43 | 0 |
| 2002 | 38 | 0 |
| 2003 | 51 | 0 |
| 2004 | 66 | 0 |
| 2005 | 53 | 0 |
| 2006 | 41 | 0 |
| 2007 | 43 | 0 |
| 2008 | 82 | 1 |
| 2009 | 63 | 0 |
| 2010 | 56 | 1 |
| 2011 | 74 | 0 |
| 2012 | 49 | 0 |
| 2013 | 50 | 0 |
| 2014 | 55 | 0 |
| 2015 | 46 | 0 |
| 2016 | 43 | 0 |
| 2017 | 39 | 0 |
| 2018 | 18 | 0 |
| 2019 | 16 | 0 |
| 2020 | 16 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
2 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? (10)
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 |
|---|---|---|---|
| * | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Summary page 7…end-user as single use, sterile-packed products. Primary Predicate Device: Primary Predicate Product Code Trade Name Manufacturer K222973 OVE, ODP IdentiTi Cervical Standalone Alphatec Table 1. Additional Predicates for the aprevo® Ce… | 2022 |
| * | K172676 | NuVasive® Modulus-C Interbody SystemSummary page 7…vical ACDF System Product 510(k) Number Trade Name Manufacturer Code K172676 ODP Modulus-C NuVasive, Inc. K111119 ODP TM-S… | 2017 |
| * | K111119 | Trabecular Metal (TM) Fusion DeviceSummary page 7…me Manufacturer Code K172676 ODP Modulus-C NuVasive, Inc. K111119 ODP TM-S Cervical Fusion Device Zimmer Spine, Inc. La… | 2011 |
| * | K151496 | Latitude-C Cervical Interbody Spacer SystemSummary page 7…119 ODP TM-S Cervical Fusion Device Zimmer Spine, Inc. Latitude-C™ Cervical Interbody Spacer K151496 ODP Degen Medical, Inc. Sy… | 2015 |
| * | K202034 | aprevo Intervertebral Body Fusion DeviceSummary page 7…ervical Interbody Spacer K151496 ODP Degen Medical, Inc. System K202034 MAX aprevo® ALIF System Carlsmed, Inc. Table 2. Additional Predicates for the ap… | 2020 |
| * | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Summary page 7…-X System 510(k) Number Product Code Trade Name Manufacturer IdentiTi™ Cervical Standalone K220782 OVE ATEC Spine, Inc Interb… | 2022 |
| * | K223190 | Hive™ Standalone Cervical SystemSummary page 7…ervical Standalone K220782 OVE ATEC Spine, Inc Interbody System K223190 OVE, ODP Hive™ Standalone Cervical System NanoHive Medical, Inc. K201453 OVE, ODP… | 2022 |
| * | K201453 | Fortilink Cages with TiPlus TechnologySummary page 7…pine, Inc Interbody System K223190 OVE, ODP Hive™ Standalone Cervical System NanoHive Medical, Inc. K201453 OVE, ODP Fortilink Cervical Standalone Paradigm Spine K222009 OVD aprev… | 2020 |
| * | K222009 | aprevo® anterior lumbar interbody fusion device with interfixationSummary page 7…P Hive™ Standalone Cervical System NanoHive Medical, Inc. K201453 OVE, ODP Fortilink Cervical Standalone Paradigm Spine K222009 OVD aprevo® ALIF-X System Carlsmed, Inc.… | 2022 |
| * | K221578 | Hexanium ACIFSummary page 8…no cam) System Product 510(k) Number Trade Name Manufacturer Code K221578 OVE Hexanium® ACIF SpineVision, Inc. Identi… | 2022 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | 2025 | 2 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 40 years and passes through 14 companies; a new generation was cleared every 8 months on median.
- 117 of the 1,158 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K250827 (Carlsmed, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K222973.
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. 2024, 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 are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: 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…
Read the full statement (313 words)
The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.
The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.
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/K242260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242260
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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