510(k) Report

510(k) · Cleared

Cleared

Alif Spinal Truss Interbody Fusion Device

K083894510(k) TraditionalCleared Jan 18, 2011750-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

4-Web Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 18, 2011 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 2 other predicates after a 750-day review. Its family tree reaches back 3 generations to 2001. 538 later devices descend from it.

Decided
Jan 18, 2011
Review
750 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K010530 (2001). 6 ancestors in all, the oldest P950002 (1996). 538 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2003: 1 other ancestor2011: 1 descendant cleared2016: 6 descendants cleared2017: 29 descendants cleared2018: 28 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2015: 4 descendants cleared2022: 57 descendants cleared2019: 37 descendants cleared2024: 75 descendants cleared2020: 55 descendants cleared2021: 50 descendants cleared2025: 61 descendants cleared2023: 79 descendants cleared2026: 54 descendants clearedK010530 · Geo Structure · Interpore Cross Intl. · 2001K020048 · Modification to Geo Structure · Interpore Cross Intl. · 2002K031672 · Spinal Concepts, Inc. Infix System · Spinal Concepts, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 37 descendants4 generations forward: 94 descendants5 generations forward: 125 descendants6 generations forward: 123 descendants7 generations forward: 87 descendants8 generations forward: 37 descendants9 generations forward: 11 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants K031672 · Spinal Concepts, Inc. Infix System · Spinal Concepts, Inc. · 2003K020048 · Modification to Geo Structure · Interpore Cross Intl. · 2002K010530 · Geo Structure · Interpore Cross Intl. · 20010+5+10
  1. Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
  2. 2 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
  3. 1 generation backK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
  4. This deviceK083894 Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC · 2011
  5. Descendant · cites it directly · 537 of its ownK112316 4-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · Recalled
  6. Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
  7. Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
  8. Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  9. Descendant · 4 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 538 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 12015: 42016: 62017: 292018: 282019: 372020: 552021: 502022: 572023: 792024: 752025: 612026: 54
2011high 79 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 538 · See all
  • K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · cites it directly537descendants
  • K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
  • K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
  • K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants
  • K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 4 generations on227descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010530Geo StructureInterpore Cross Intl.2001—
−2K020048Modification to Geo StructureInterpore Cross Intl.2002—
−1K031672Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc.2003—
0 (this device)K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011—
+1K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20111
+2K150481Cascadia Interbody SystemK2m, Inc.20153
+3K160125Cascadia Interbody SystemK2m2016—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201410
201540
201660
2017290
2018280
2019370
2020550
2021500
2022570
2023790
2024750
2025610
2026540
FIG. 1 — Lineage of K083894, 2001–2026Source: 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 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? (3)

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
*P950002Bak Interbody Fusion System
Summary page 1
…ly cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Infix System from Spinal Concepts (K03 1672) and the Brantigan Lumbar I/F Cage (AcroMed, P960025). (Add Titan Spine?) Performa…
Zimmer Spine, Inc.1996—
*K031672Spinal Concepts, Inc. Infix System
Summary page 1
…ns for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Infix System from Spinal Concepts (K03 1672) and the Brantigan Lumbar I/F Cage (AcroMed, P960025). (Add Titan Spine?) Performance Testing: Preclinical testing performed on…
Spinal Concepts, Inc.2003—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Infix System from Spinal Concepts (K03 1672) and the Brantigan Lumbar I/F Cage (AcroMed, P960025). (Add Titan Spine?) Performance Testing: Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included stati…
Depuy Spine, Inc.1999—

Also cleared against P950002: 34 other devices →

What descends from it? (538)

See all 538

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

NumberDeviceApplicantDecidedDescendants
K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.2011537
K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235
K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711
K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810
K153436LATERAL Spine Truss System4Web, Inc.20165

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 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K112316 (4-Web, Inc., 2011) has gone furthest, with 537 descendants of its own.
  • 34 other devices also cite its predicate P950002.

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. 2011, 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 ALIF Spinal Truss Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to. treatment with the devices. The device must be used with supplemental fixation and must be used with autogrgft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Indications for use as stated in the FDA summary.

Also cleared against P950002

34 other devices cite the same predicate.

  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K143479Bluefin Interbody SystemTides Medical · 2015

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/K083894 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083894: Alif Spinal Truss Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083894

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026