510(k) · Cleared
ClearedSIRION Lateral Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 2, 2020 as substantially equivalent to K152512 (Astura Medical, 2016) and 8 other predicates after a 248-day review. Its family tree reaches back 24 generations to 1984. 1 of the 338 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Apr 2, 2020
- Review
- 248 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 24 generations to K841189 (1984). 323 ancestors in all. 14 later devices descend from it, 4 citing it directly. 1 of the 338 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- Descendant · cites it directly · 6 of its ownK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
- Descendant · cites it directly · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- Descendant · cites it directly · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK241487 Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 5 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 4 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 5 of 14 · See all- K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021 · cites it directly6descendants
- K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · cites it directly5descendants
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · cites it directly3descendants
- K240126ProAM ALIF SystemPro Surgical, Inc. · 2024 · 2 generations on2descendants
- K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −5 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −1 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| 0 (this device) | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| +1 | K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | 2021 | — |
| +1 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| +1 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +2 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | — |
| +2 | K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 16 | 0 |
| 2004 | 24 | 0 |
| 2005 | 20 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 44 | 1 |
| 2009 | 28 | 0 |
| 2010 | 18 | 0 |
| 2011 | 22 | 0 |
| 2012 | 12 | 0 |
| 2013 | 15 | 0 |
| 2014 | 15 | 0 |
| 2015 | 12 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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.
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? (9)
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….3080 21 CFR section 888.3060 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, K16… | 2016 |
| * | K163481 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…888.3060 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); Alphatec Spin… | 2017 |
| * | K172947 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…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); Alphatec Spine ATEC AL… | 2018 |
| * | K182877 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…anel 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); Alphatec Spine ATEC ALIF and LL… | 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); Alphatec Spine ATEC ALIF and LLIF Spacer System (K182746) NuVa… | 2014 |
| * | K163543 | Biomet Fusion SystemSummary page 4…Posterior Lumbar Interbody System (K152512) Additional Predicate Half Dome (K163481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543); Alphatec Spine ATEC ALIF and LLIF Spacer System (K182746) NuVasive Deca… | 2017 |
| * | K182746 | ATEC ALIF and LLIF Spacer SystemSummary page 4…3481, K172947, K182877) Device(s) Biomet Fusion System (K141791, K163543); Alphatec Spine ATEC ALIF and LLIF Spacer System (K182746) NuVasive Decade Lateral Plate System (K130868) Genesys Spine Anterior Bu… | 2018 |
| * | K130868 | Nuvasive Decade Lateral Plate SystemSummary page 4…141791, K163543); Alphatec Spine ATEC ALIF and LLIF Spacer System (K182746) NuVasive Decade Lateral Plate System (K130868) Genesys Spine Anterior Buttress Plate System (K133911) Device Description The Sirion Latera… | 2013 |
| * | K133911 | Genesys Spine Anterior Buttress Plate SystemSummary page 4…cer System (K182746) NuVasive Decade Lateral Plate System (K130868) Genesys Spine Anterior Buttress Plate System (K133911) Device Description The Sirion Lateral Lumbar Interbody devices are implants developed for t… | 2014 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 37 of the 323 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202495 (Astura Medical, LLC, 2021) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K152512.
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. 2020, 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 SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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…
Read the full statement (269 words)
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192006: SIRION Lateral Lumbar 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/K192006
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