510(k) Report

PMA · Approved

Recalled · 2005

Inter Fix Threaded Fusion Device

P970015PMAApproved May 14, 1999780-day reviewClass II21 CFR 888.3080Recalls 1

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

Sofamor Danek · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on May 14, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 780-day review. 1 of the 1,427 devices in its family, counting itself, has a Class I recall. 1,426 later devices descend from it. It has been recalled once.

Decided
May 14, 1999
Review
780 days
Class
Class II
Product code
MAX
Recalls
1

1,426 later devices descend from it, 19 citing it directly. 1 of the 1,427 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 12 descendants cleared2015: 63 descendants cleared2009: 9 descendants cleared2007: 1 descendant cleared2010: 16 descendants cleared2012: 31 descendants cleared2011: 22 descendants cleared2022: 104 descendants cleared2017: 109 descendants cleared2013: 48 descendants cleared2014: 67 descendants cleared2020: 106 descendants cleared2016: 77 descendants cleared2018: 103 descendants cleared2021: 103 descendants cleared, 1 with a Class I recall12023: 136 descendants cleared2024: 123 descendants cleared2019: 107 descendants cleared2026: 88 descendants cleared2025: 101 descendants cleared1995200020052010201520202025
  1. This deviceP970015 Inter Fix Threaded Fusion DeviceSofamor Danek · 1999
  2. Descendant · cites it directly · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  3. Descendant · 2 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
  4. Descendant · cites it directly · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  5. Descendant · cites it directly · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  6. Descendant · cites it directly · 864 of its ownK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010

Showing 5 of 1,426 descendants. See all descendants

Descendants cleared per year

2007: 12008: 122009: 92010: 162011: 222012: 312013: 482014: 672015: 632016: 772017: 1092018: 1032019: 1072020: 1062021: 1032022: 1042023: 1362024: 1232025: 1012026: 88
2007high 136 (2023) · low 1 (2007)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,426 · See all
  • K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly1,103descendants
  • K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on1,008descendants
  • K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly932descendants
  • K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · cites it directly907descendants
  • K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010 · cites it directly864descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P970015Inter Fix Threaded Fusion DeviceSofamor Danek1999—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek2010—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
+1K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
2008120
200990
2010160
2011220
2012310
2013480
2014670
2015630
2016770
20171090
20181030
20191070
20201060
20211031
20221040
20231360
20241230
20251010
2026880
FIG. 1 — Lineage of P970015, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1,426)

See all 1,426

19 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
K080083Intrepid Spinal SystemMedtronic Sofamor Danek2008932
K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907
K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864
K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838
K072226Impix SpacerMedicrea Technologies2007812
K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796
K090064Eminent Spine Interbody Fusion SystemEminent Spine2009701
K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564
K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.2009476

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 27, 2005Not classifiedZ-1090-05OtherThe product is labeled as sterile, but this lot was not sterilized.

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 Sofamor Danek

24 FDA decisions under this applicant name. See the company

  • P970015/S031Inter Fix TM Threaded Fusion DeviceSofamor Danek · 2005
  • P970015/S029LT-Cage Lumbar Tapered Fusion DeviceSofamor Danek · 2005
  • P970015/S030LT-Cage Lumbar Tapered Fusion Device (TI and Peek)Sofamor Danek · 2005
  • P970015/S028Inter Fix Threaded Fusion DeviceSofamor Danek · 2004
  • P970015/S026LT-Cage Peek Lumbar Tapered Fusion DeviceSofamor Danek · 2004

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/P970015 · printed Nov 6, 2026

Cite this page

510(k) Report. “P970015: Inter Fix Threaded Fusion Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970015

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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