510(k) · Cleared
ClearedProAM ALIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro Surgical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on May 3, 2024 as substantially equivalent to K230894 (Nu Vasive, Incorporated, 2023) and 4 other predicates after a 108-day review. Its family tree reaches back 32 generations to 1984. 2 of the 1,439 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 3, 2024
- Review
- 108 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 32 generations to K841189 (1984). 1,436 ancestors in all, the oldest K761228 (1976). 2 later devices descend from it, 2 citing it directly. 2 of the 1,439 devices in this family, counting this one, have a Class I recall.
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations between
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 1 generation backK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- This deviceK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251644 ProAM ALIF SystemPro Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242517 ProAM ACDF SystemPro Surgical, Inc. · 2024
Show all 32 generations
- Root · 32 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 31 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 30 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 29 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 28 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 26 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 25 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 24 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 22 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 21 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 20 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 19 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 18 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 17 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 16 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 15 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 14 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 13 generations backK160955 Tritanium® PL CageStryker · 2016
- 12 generations backK162262 Tritanium® PL CageStryker · 2016
- 11 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 10 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 9 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 8 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- 7 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- 6 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
- 5 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
- 4 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
- 3 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
- 2 generations backK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- 1 generation backK232097 IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023 · Recalled
- This deviceK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −32 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −31 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −30 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −29 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −28 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −26 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −25 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −24 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −22 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −21 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −20 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −19 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −18 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −17 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −16 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −15 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −14 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −13 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −12 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −11 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −10 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −9 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −8 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| −7 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| −6 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
| −5 | K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021 | 1 |
| −4 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −3 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022 | — |
| −2 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| −1 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 1 |
| 0 (this device) | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | — |
| +1 | K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025 | — |
| +1 | K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024 | — |
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 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 4 | 0 |
| 1987 | 1 | 0 |
| 1988 | 4 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 2 | 0 |
| 1992 | 11 | 0 |
| 1993 | 9 | 0 |
| 1994 | 16 | 0 |
| 1995 | 24 | 0 |
| 1996 | 28 | 0 |
| 1997 | 29 | 0 |
| 1998 | 40 | 0 |
| 1999 | 30 | 0 |
| 2000 | 45 | 0 |
| 2001 | 56 | 0 |
| 2002 | 57 | 0 |
| 2003 | 58 | 0 |
| 2004 | 80 | 0 |
| 2005 | 73 | 0 |
| 2006 | 60 | 0 |
| 2007 | 55 | 0 |
| 2008 | 103 | 1 |
| 2009 | 76 | 0 |
| 2010 | 72 | 1 |
| 2011 | 85 | 0 |
| 2012 | 56 | 0 |
| 2013 | 61 | 0 |
| 2014 | 57 | 0 |
| 2015 | 50 | 0 |
| 2016 | 43 | 0 |
| 2017 | 37 | 0 |
| 2018 | 23 | 0 |
| 2019 | 16 | 0 |
| 2020 | 16 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K230894 | NuVasive Modulus ALIF SystemSummary page 5…e Class: Class II Regulation Number: 12 CFR § 888.3080 Product Code: OVD Predicate Devices Primary Predicate Device NuVasive Modulus ALIF System – K230894 Additional Predicate Devices Osseus Fusion Systems Pisces-SA Standalone ALIF Interbody System – K223413 Astura El Capital Anteri… | 2023 |
| * | K223413 | Pisces™-SA STANDALONE ALIF Interbody SystemSummary page 5…Devices Primary Predicate Device NuVasive Modulus ALIF System – K230894 Additional Predicate Devices Osseus Fusion Systems Pisces-SA Standalone ALIF Interbody System – K223413 Astura El Capital Anterior Lumbar Interbody Fusion – K222554 Spinal Elements Magnum+ – K083475 ATEC IdentiTi Interbody Systems –… | 2023 |
| * | K222554 | EL CAPITAN Anterior Lumbar Interbody FusionSummary page 5…m – K230894 Additional Predicate Devices Osseus Fusion Systems Pisces-SA Standalone ALIF Interbody System – K223413 Astura El Capital Anterior Lumbar Interbody Fusion – K222554 Spinal Elements Magnum+ – K083475 ATEC IdentiTi Interbody Systems – K232097 Device Description The ProAM™ ALIF System is an inte… | 2023 |
| * | K083475 | Lucent MagnumSummary page 5…Devices Osseus Fusion Systems Pisces-SA Standalone ALIF Interbody System – K223413 Astura El Capital Anterior Lumbar Interbody Fusion – K222554 Spinal Elements Magnum+ – K083475 ATEC IdentiTi Interbody Systems – K232097 Device Description The ProAM™ ALIF System is an intervertebral body fusion system that… | 2009 |
| * | K232097 | IdentiTi ALIF Interbody SystemsSummary page 5…andalone ALIF Interbody System – K223413 Astura El Capital Anterior Lumbar Interbody Fusion – K222554 Spinal Elements Magnum+ – K083475 ATEC IdentiTi Interbody Systems – K232097 Device Description The ProAM™ ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion… | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 companies; a new generation was cleared every 8 months on median.
- 152 of the 1,436 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K251644 (Pro Surgical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K230894.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also…
Read the full statement (320 words)
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
Interbody devices used with three screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation.
Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
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/K240126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240126: ProAM ALIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240126
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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