510(k) · Cleared
ClearedEL CAPITAN Anterior Lumber Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Apr 21, 2020 as substantially equivalent to K152512 (Astura Medical, 2016) and 9 other predicates after a 223-day review. Its family tree reaches back 20 generations to 1984. 10 later devices descend from it.
- Decided
- Apr 21, 2020
- Review
- 223 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 20 generations to K841189 (1984). 287 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- This deviceK192492 EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020
- Descendant · cites it directly · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- Descendant · cites it directly · 3 of its ownK214047 EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical · 2022
- Descendant · 2 generations on · 2 of its ownK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK170592 NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated · 2017
- This deviceK192492 EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · cites it directly5descendants
- K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical · 2022 · cites it directly3descendants
- K240126ProAM ALIF SystemPro Surgical, Inc. · 2024 · 2 generations on2descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · 2 generations on2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | 2020 | — |
| +1 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| +1 | K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Astura Medical | 2022 | — |
| +2 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | — |
| +2 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| +3 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 19 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 40 | 0 |
| 2009 | 27 | 0 |
| 2010 | 19 | 0 |
| 2011 | 17 | 0 |
| 2012 | 9 | 0 |
| 2013 | 15 | 0 |
| 2014 | 13 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 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.
Planning a device in OVD? 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? (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 |
|---|---|---|---|
| * | K152512 | Half Dome Posterior Lumbar Interbody SystemSummary page 4…OVD CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Device HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K1635… | 2016 |
| * | K163481 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…ion 888.3080 Device Panel Orthopedic Primary Predicate Device HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyrami… | 2017 |
| * | K172947 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…080 Device Panel Orthopedic Primary Predicate Device HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyramid Fixatio… | 2018 |
| * | K182877 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…e Panel Orthopedic Primary Predicate Device HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyramid Fixation System… | 2019 |
| * | K141791 | Biomet Fusion SystemSummary page 4…HALF DOME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyramid Fixation System (K013665) NuVasive BASE Interfi… | 2014 |
| * | K163543 | Biomet Fusion SystemSummary page 4…ME Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyramid Fixation System (K013665) NuVasive BASE Interfixated Sys… | 2017 |
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 4…Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543) Medtronic Pyramid Fixation System (K013665) NuVasive BASE Interfixated System (K170592) Stryker AVS (K143163)… | 2002 |
| * | K170592 | NuVasive BASE Interfixated Titanium SystemSummary page 4…met Fusion System (K141791, K163543) Medtronic Pyramid Fixation System (K013665) NuVasive BASE Interfixated System (K170592) Stryker AVS (K143163) Core-Link M3 (K180814) Device Description Th… | 2017 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 4…Medtronic Pyramid Fixation System (K013665) NuVasive BASE Interfixated System (K170592) Stryker AVS (K143163) Core-Link M3 (K180814) Device Description The EL CAPITAN Anterior Lumbar Interbody devices ar… | 2015 |
| * | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar SystemSummary page 4…K013665) NuVasive BASE Interfixated System (K170592) Stryker AVS (K143163) Core-Link M3 (K180814) Device Description The EL CAPITAN Anterior Lumbar Interbody devices are implants developed fo… | 2018 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 31 of the 287 ancestors have a recall of any class.
- Of its descendants, K222554 (Astura Medical, 2023) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K152512.
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. 2020, 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 EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1 -L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved…
Read the full statement (183 words)
The EL CAPITAN Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1 -L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192492: EL CAPITAN Anterior Lumber Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192492
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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