510(k) Report

510(k) · Cleared

Cleared

Half Dome Posterior Lumbar Interbody System

K152512510(k) TraditionalCleared Jan 28, 2016148-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Astura Medical · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 28, 2016 as substantially equivalent to K082310 (Seaspine, Inc., 2008) and 5 other predicates after a 148-day review. Its family tree reaches back 2 generations to 2007. 33 later devices descend from it.

Decided
Jan 28, 2016
Review
148 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K071724 (2007). 7 ancestors in all, the oldest P950019 (1996). 33 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2008: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor2007: 1 other ancestor2018: 1 descendant cleared2019: 1 descendant cleared2023: 7 descendants cleared2017: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared2020: 3 descendants cleared2025: 7 descendants cleared2024: 7 descendants cleared2026: 2 descendants clearedK071724 · Lucent · Spinal Elements, Inc. · 2007K081968 · Modification to Lucent · Spinal Elements, Inc. · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 5 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K081968 · Modification to Lucent · Spinal Elements, Inc. · 2008K071724 · Lucent · Spinal Elements, Inc. · 20070+5
  1. Root · 2 generations backK071724 LucentSpinal Elements, Inc. · 2007
  2. 1 generation backK081968 Modification to LucentSpinal Elements, Inc. · 2008
  3. This deviceK152512 Half Dome Posterior Lumbar Interbody SystemAstura Medical · 2016
  4. Descendant · cites it directly · 31 of its ownK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
  5. Descendant · cites it directly · 22 of its ownK172947 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2018
  6. Descendant · cites it directly · 21 of its ownK182877 HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
  7. Descendant · cites it directly · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
  8. Descendant · cites it directly · 10 of its ownK192492 EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 12020: 32021: 22022: 22023: 72024: 72025: 72026: 2
2017high 7 (2023) · low 1 (2017)2026

Most influential descendants

Showing 5 of 33 · See all
  • K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017 · cites it directly31descendants
  • K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2018 · cites it directly22descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K071724LucentSpinal Elements, Inc.2007—
−1K081968Modification to LucentSpinal Elements, Inc.2008—
0 (this device)K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical2016—
+1K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical2017—
+1K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical2018—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC2019—
+1K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC2020—
+1K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200710
200810
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201910
202030
202120
202220
202370
202470
202570
202620
FIG. 1 — Lineage of K152512, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082310Hollywood, Pacifica, Redondo, Ventura
Summary page 4
…de MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate SEASPINE Pacifica Cage (K082310) Device Synthes T-PAL Spacer (K100089) Additional Predicate DePuy Brantigan I/F Cage (P960025) Device…
Seaspine, Inc.2008—
*K100089Synthes T-Pal Spacer
Summary page 4
…080 Device Panel Orthopedic Primary Predicate SEASPINE Pacifica Cage (K082310) Device Synthes T-PAL Spacer (K100089) Additional Predicate DePuy Brantigan I/F Cage (P960025) Devices Surgical Dynamics Ray Threaded Lumbar Fusion…
Synthes Spine20101
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 4
…SEASPINE Pacifica Cage (K082310) Device Synthes T-PAL Spacer (K100089) Additional Predicate DePuy Brantigan I/F Cage (P960025) Devices Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019) Spinal Elements Luce…
Depuy Spine, Inc.1999—
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 4
…Synthes T-PAL Spacer (K100089) Additional Predicate DePuy Brantigan I/F Cage (P960025) Devices Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019) Spinal Elements Lucent Cage (K071724/K081968) The Half Dome Posterior Lumbar In…
Stryker Spine19961
*K071724Lucent
Summary page 4
…Puy Brantigan I/F Cage (P960025) Devices Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019) Spinal Elements Lucent Cage (K071724/K081968) The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants de…
Spinal Elements, Inc.2007—
*K081968Modification to Lucent
Summary page 4
…tigan I/F Cage (P960025) Devices Surgical Dynamics Ray Threaded Lumbar Fusion Cage (P950019) Spinal Elements Lucent Cage (K071724/K081968) The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants developed…
Spinal Elements, Inc.2008—

Also cleared against K082310: 17 other devices →

What descends from it? (33)

See all 33

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731
K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822
K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921
K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014
K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010
K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216
K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223
K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230

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 9 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K163481 (Astura Medical, 2017) has gone furthest, with 31 descendants of its own.
  • 17 other devices also cite its predicate K082310.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Half Dome Posterior Lumbar Interbody System are 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 as stated in the FDA summary.

Also cleared against K082310

17 other devices cite the same predicate.

  • K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022
  • K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation · 2020
  • K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation · 2020
  • K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation · 20191 recall
  • K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System…SeaSpine Orthopedics Corporation · 2017
  • K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation · 2017

More from Astura Medical

21 FDA decisions under this applicant name. See the company

  • K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2026
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K240160EGPS Navigated InstrumentsAstura Medical · 2024
  • K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K152512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152512: 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/K152512

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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