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 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 3, 2017 as substantially equivalent to K152512 (Astura Medical, 2016) and 4 other predicates after a 142-day review. Its family tree reaches back 14 generations to 2001. 31 later devices descend from it.
- Decided
- May 3, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K003155 (2001). 90 ancestors in all, the oldest K841189 (1984). 31 later devices descend from it, 6 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
- This deviceK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
- Descendant · cites it directly · 21 of its ownK182877 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 · 8 of its ownK201287 Impulse Interbody Fusion SystemDegen Medical · 2020
- Descendant · 2 generations on · 7 of its ownK210090 Impulse AM Interbody Fusion SystemDegen Medical · 2021
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
- This deviceK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019 · cites it directly21descendants
- K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · cites it directly14descendants
- K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020 · cites it directly10descendants
- K201287Impulse Interbody Fusion SystemDegen Medical · 2020 · cites it directly8descendants
- K210090Impulse AM Interbody Fusion SystemDegen Medical · 2021 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −1 | K160154 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2016 | — |
| 0 (this device) | K163481 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2017 | — |
| +1 | 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 | K201287 | Impulse Interbody Fusion System | Degen Medical | 2020 | — |
| +2 | K210090 | Impulse AM Interbody Fusion System | Degen Medical | 2021 | — |
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 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 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? (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 |
|---|---|---|---|
| * | K152512 | Half Dome Posterior Lumbar Interbody SystemSummary page 4…ice — lumbar Class Product Code MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Device Half Dome Posterior Lumbar Interbody System (K152512) Secondary Predicate Device ALTA Cervical Interbody Spacer (K160154) Next OrthoSurgical InterForm Interbody Cage System (K1310… | 2016 |
| * | K160154 | ALTA Anterior Cervical Interbody SpacerSummary page 4…080 Device Panel Orthopedic Primary Predicate Device Half Dome Posterior Lumbar Interbody System (K152512) Secondary Predicate Device ALTA Cervical Interbody Spacer (K160154) Next OrthoSurgical InterForm Interbody Cage System (K131082) Titan Spine Endoskeleton TT IBD (K083714) Titan Spine Endoskeleto… | 2016 |
| * | K131082 | Interform Interbody Cage SystemSummary page 4…me Posterior Lumbar Interbody System (K152512) Secondary Predicate Device ALTA Cervical Interbody Spacer (K160154) Next OrthoSurgical InterForm Interbody Cage System (K131082) Titan Spine Endoskeleton TT IBD (K083714) Titan Spine Endoskeleton TO Interbody Fusion Device (K102067) Device Description Th… | 2013 |
| * | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd)Summary page 4…512) Secondary Predicate Device ALTA Cervical Interbody Spacer (K160154) Next OrthoSurgical InterForm Interbody Cage System (K131082) Titan Spine Endoskeleton TT IBD (K083714) Titan Spine Endoskeleton TO Interbody Fusion Device (K102067) Device Description The Half Dome Posterior Lumbar Interbody dev… | 2009 |
| * | K102067 | Endoskeleton toSummary page 4…r (K160154) Next OrthoSurgical InterForm Interbody Cage System (K131082) Titan Spine Endoskeleton TT IBD (K083714) Titan Spine Endoskeleton TO Interbody Fusion Device (K102067) Device Description The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classic… | 2010 |
What descends from it? (31)
See all 316 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182877 | HALF DOME Posterior Lumbar Interbody System | 2019 | 21 |
| K192006 | SIRION Lateral Lumbar Interbody System | 2020 | 14 |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | 2020 | 10 |
| K201287 | Impulse Interbody Fusion System | 2020 | 8 |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | 2021 | 6 |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | 2023 | 5 |
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 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 10 of the 90 ancestors have a recall of any class.
- Of its descendants, K182877 (Astura Medical, LLC, 2019) has gone furthest, with 21 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. 2017, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163481: HALF DOME Posterior 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/K163481
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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