510(k) · Cleared
Clearedaprevo® posterior/transforaminal lumbar interbody fusion device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carlsmed, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 30, 2025 as substantially equivalent to K241332 (Carlsmed, Inc., 2024) and 2 other predicates after a 91-day review. Its family tree reaches back 33 generations to 1984. 1 of the 684 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 30, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 33 generations to K841189 (1984). 682 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 684 devices in this family, counting this one, has a Class I recall.
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 29 generations between
- 3 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- 1 generation backK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- This deviceK250987 aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260385 aprevo® anterior and lateral lumbar interbody system; aprevo®…Carlsmed, Inc. · 2026
Show all 33 generations
- Root · 33 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 32 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 31 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 30 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 29 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 27 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 26 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 25 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 23 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 22 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 21 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 20 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 19 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 18 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 17 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 16 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 15 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 14 generations backK160955 Tritanium® PL CageStryker · 2016
- 13 generations backK162262 Tritanium® PL CageStryker · 2016
- 12 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 11 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 10 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 9 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 7 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 6 generations backK201193 SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica…SeaSpine Orthopedics Corporation · 2020
- 5 generations backK210583 SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation · 2021
- 4 generations backK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
- 3 generations backK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
- 2 generations backK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
- 1 generation backK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024
- This deviceK250987 aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
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 |
|---|---|---|---|---|---|
| −33 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −32 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −31 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −30 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −29 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −27 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −26 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −25 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −23 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −22 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −21 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −20 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −19 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −18 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −17 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −16 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −15 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −14 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −13 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −11 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −10 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −9 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −8 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −7 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −6 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo… | SeaSpine Orthopedics Corporation | 2020 | — |
| −5 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | — |
| −4 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | — |
| −3 | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | — |
| −2 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | — |
| −1 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral… | SeaSpine Orthopedics Corporation | 2024 | — |
| 0 (this device) | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025 | — |
| +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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 8 | 0 |
| 2001 | 12 | 0 |
| 2002 | 17 | 0 |
| 2003 | 23 | 0 |
| 2004 | 43 | 0 |
| 2005 | 30 | 0 |
| 2006 | 19 | 0 |
| 2007 | 25 | 0 |
| 2008 | 56 | 1 |
| 2009 | 44 | 0 |
| 2010 | 33 | 0 |
| 2011 | 50 | 0 |
| 2012 | 37 | 0 |
| 2013 | 37 | 0 |
| 2014 | 42 | 0 |
| 2015 | 35 | 0 |
| 2016 | 31 | 0 |
| 2017 | 29 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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.
1 device in this family has 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Summary page 5…Product Code Trade Name Manufacturer Primary Predicate Device aprevo® transforaminal lumbar K241332 MAX Carlsmed, Inc. interbody fus… | 2024 |
| * | K241019 | aprevo® TLIF-C Articulating SystemSummary page 5…. interbody fusion device Additional Predicate Device(s) aprevo® TLIF-C Articulating K241019 MAX Carlsmed, Inc. Syste… | 2024 |
| * | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…Summary page 5…Carlsmed, Inc. System SeaSpine Orthopedics K241466 MAX WaveForm TO Interbody System Cor… | 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? (1 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 17 companies; a new generation was cleared every 8 months on median.
- 71 of the 682 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260385 (Carlsmed, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K241332.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult…
Read the full statement (269 words)
The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.
The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DOD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DOD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). The device may be implanted via an open or minimally invasive approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250987: aprevo® posterior/transforaminal lumbar interbody fusion device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250987
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