510(k) · Cleared
ClearedHALF DOME Posterior 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 May 3, 2019 as substantially equivalent to K113447 (Globus Medical, Inc., 2012) and 7 other predicates after a 200-day review. Its family tree reaches back 15 generations to 2001. 21 later devices descend from it.
- Decided
- May 3, 2019
- Review
- 200 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 15 generations to K003155 (2001). 121 ancestors in all, the oldest K841189 (1984). 21 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
- 1 generation backK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
- This deviceK182877 HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
- Descendant · cites it directly · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- Descendant · cites it directly · 10 of its ownK192492 EL CAPITAN Anterior Lumber 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 · 2 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
- 1 generation backK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
- This deviceK182877 HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · cites it directly14descendants
- K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020 · cites it directly10descendants
- 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 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −2 | K160154 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2016 | — |
| −1 | K163481 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2017 | — |
| 0 (this device) | K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | 2019 | — |
| +1 | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| +1 | K192492 | EL CAPITAN Anterior Lumber 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 | — |
| +2 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 14 | 0 |
| 2004 | 15 | 0 |
| 2005 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 14 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 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.
Planning a device in MAX? 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? (8)
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 |
|---|---|---|---|
| * | K113447 | Rise SpacerSummary page 4…MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Globus Medical Rise® Intervertebral Body Fusion Device (K113447) Device Secondary Predicate Spinal Elements Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers… | 2012 |
| * | K071724 | LucentSummary page 4…el Orthopedic Primary Predicate Globus Medical Rise® Intervertebral Body Fusion Device (K113447) Device Secondary Predicate Spinal Elements Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar I… | 2007 |
| * | K081968 | Modification to LucentSummary page 4…Orthopedic Primary Predicate Globus Medical Rise® Intervertebral Body Fusion Device (K113447) Device Secondary Predicate Spinal Elements Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody… | 2008 |
| * | K102293 | Caliber SpacerSummary page 4…ervertebral Body Fusion Device (K113447) Device Secondary Predicate Spinal Elements Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) Device Description The Ha… | 2011 |
| * | K123231 | Caliber SpacersSummary page 4…al Body Fusion Device (K113447) Device Secondary Predicate Spinal Elements Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) Device Description The Half Dome P… | 2013 |
| * | K152512 | Half Dome Posterior Lumbar Interbody SystemSummary page 4…Lucent Spacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) Device Description The Half Dome Posterior Lumbar Interbody devices are implants developed for… | 2016 |
| * | K163481 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…pacer (K071724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) Device Description The Half Dome Posterior Lumbar Interbody devices are implants developed for t… | 2017 |
| * | K172947 | HALF DOME Posterior Lumbar Interbody SystemSummary page 4…71724, K081968) Device Globus Medical Caliber® Spacers (K102293, K123231) Half Dome Posterior Lumbar Interbody System (K152512, K163481, K172947) Device Description The Half Dome Posterior Lumbar Interbody devices are implants developed for the substi… | 2018 |
What descends from it? (21)
See all 217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192006 | SIRION Lateral Lumbar Interbody System | 2020 | 14 |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | 2020 | 10 |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | 2021 | 6 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | 2023 | 5 |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | 2022 | 3 |
| K243739 | AxCess® Expandable Interbody System | 2025 | 0 |
| K223335 | SIRION Lateral Lumbar Interbody System | 2023 | 0 |
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 18 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 11 of the 121 ancestors have a recall of any class.
- Of its descendants, K192006 (Astura Medical, LLC, 2020) has gone furthest, with 14 descendants of its own.
- 26 other devices also cite its predicate K113447.
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. 2019, 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 HALF DOME POSTERIOR 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). HALF DOME 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182877: HALF DOME Posterior Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182877
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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