510(k) Report

PMA · Approved

Approved

Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws

P960025PMAApproved Feb 2, 1999922-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

Depuy Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on Feb 2, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 922-day review. 1 of the 1,715 devices in its family, counting itself, has a Class I recall. 1,714 later devices descend from it.

Decided
Feb 2, 1999
Review
922 days
Class
Class II
Product code
MAX
Recalls
None

1,714 later devices descend from it, 99 citing it directly. 1 of the 1,715 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2015: 85 descendants cleared2012: 64 descendants cleared2010: 36 descendants cleared2009: 23 descendants cleared2007: 3 descendants cleared2011: 60 descendants cleared2013: 75 descendants cleared2017: 128 descendants cleared2016: 107 descendants cleared2008: 21 descendants cleared2018: 115 descendants cleared2014: 100 descendants cleared2019: 114 descendants cleared2005: 1 descendant cleared2024: 126 descendants cleared2022: 109 descendants cleared2021: 107 descendants cleared, 1 with a Class I recall12023: 141 descendants cleared2020: 109 descendants cleared2025: 101 descendants cleared2026: 89 descendants cleared1995200020052010201520202025
  1. This deviceP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
  2. Descendant · cites it directly · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  3. Descendant · cites it directly · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
  4. Descendant · cites it directly · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
  5. Descendant · cites it directly · 1,055 of its ownK072791 Oracle Spacer, Opal SpacerSynthes Spine · 2007 · Recalled
  6. Descendant · 2 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010

Showing 5 of 1,714 descendants. See all descendants

Descendants cleared per year

2005: 12007: 32008: 212009: 232010: 362011: 602012: 642013: 752014: 1002015: 852016: 1072017: 1282018: 1152019: 1142020: 1092021: 1072022: 1092023: 1412024: 1262025: 1012026: 89
2005high 141 (2023) · low 0 (2006)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,714 · See all
  • K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly1,103descendants
  • K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · cites it directly1,102descendants
  • K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · cites it directly1,091descendants
  • K072791Oracle Spacer, Opal SpacerSynthes Spine · 2007 · cites it directly1,055descendants
  • K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on1,008descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsDepuy Spine, Inc.1999—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
+1K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine2008—
+1K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.2008—
+1K072791Oracle Spacer, Opal SpacerSynthes Spine20071
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200730
2008210
2009230
2010360
2011600
2012640
2013750
20141000
2015850
20161070
20171280
20181150
20191140
20201090
20211071
20221090
20231410
20241260
20251010
2026890
FIG. 1 — Lineage of P960025, 1999–2026Source: 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 PMA database (decision fields and supplements), 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. #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

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (1,714)

See all 1,714

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

NumberDeviceApplicantDecidedDescendants
K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103
K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102
K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091
K072791Oracle Spacer, Opal SpacerSynthes Spine20071,055
K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008
K082128Depuy Spine Lateral Cage SystemDepuy Spine2008933
K080083Intrepid Spinal SystemMedtronic Sofamor Danek2008932
K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864
K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc.2008848
K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K073291 (Medtronic Sofamor Danek USA, Inc., 2008) has gone furthest, with 1,103 descendants of its own.

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.

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—

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

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/P960025 · printed Nov 6, 2026

Cite this page

510(k) Report. “P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960025

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026