510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

4-Web Alif Spinal Truss System (STS)

K112316510(k) SpecialCleared Dec 14, 2011125-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

4-Web, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 14, 2011 as substantially equivalent to K083894 (4-Web Spine, LLC, 2011) and 2 other predicates after a 125-day review. Its family tree reaches back 4 generations to 2001. 537 later devices descend from it. It has been recalled once.

Decided
Dec 14, 2011
Review
125 days
Class
Class II
Product code
MAX
Recalls
1
Predicates
3

Its longest line of descent runs back 4 generations to K010530 (2001). 8 ancestors in all, the oldest P950002 (1996). 537 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestor2003: 1 other ancestor2014: 1 descendant cleared2016: 6 descendants cleared2017: 29 descendants cleared2015: 4 descendants cleared2018: 28 descendants cleared2012: 1 descendant cleared2020: 55 descendants cleared2022: 57 descendants cleared2019: 37 descendants cleared2024: 75 descendants cleared2026: 54 descendants cleared2023: 79 descendants cleared2021: 50 descendants cleared2025: 61 descendants clearedK010530 · Geo Structure · Interpore Cross Intl. · 2001K020048 · Modification to Geo Structure · Interpore Cross Intl. · 2002K031672 · Spinal Concepts, Inc. Infix System · Spinal Concepts, Inc. · 2003K083894 · Alif Spinal Truss Interbody Fusion Device · 4-Web Spine, LLC · 20111995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 31 descendants3 generations forward: 98 descendants4 generations forward: 132 descendants5 generations forward: 125 descendants6 generations forward: 87 descendants7 generations forward: 37 descendants8 generations forward: 11 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants K083894 · Alif Spinal Truss Interbody Fusion Device · 4-Web Spine, LLC · 2011K031672 · 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 · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
  2. 3 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
  3. 2 generations backK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
  4. 1 generation backK083894 Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC · 2011
  5. This deviceK112316 4-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011
  6. Descendant · cites it directly · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
  7. Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
  8. Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  9. Descendant · 3 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  10. Descendant · cites it directly · 211 of its ownK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015

Showing 5 of 537 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 42016: 62017: 292018: 282019: 372020: 552021: 502022: 572023: 792024: 752025: 612026: 54
2012high 79 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 537 · See all
  • K150481Cascadia Interbody SystemK2m, Inc. · 2015 · cites it directly459descendants
  • K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
  • K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
  • K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on227descendants
  • K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015 · cites it directly211descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K010530Geo StructureInterpore Cross Intl.2001—
−3K020048Modification to Geo StructureInterpore Cross Intl.2002—
−2K031672Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc.2003—
−1K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011—
0 (this device)K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.2011—
+1K150481Cascadia Interbody SystemK2m, Inc.20153
+2K160125Cascadia Interbody SystemK2m2016—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+1K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200310
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201540
201660
2017290
2018280
2019370
2020550
2021500
2022570
2023790
2024750
2025610
2026540
FIG. 1 — Lineage of K112316, 2001–2026Source: 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? (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
*K083894Alif Spinal Truss Interbody Fusion Device
Summary page 2
…isco, TX 75033 TF: (800) 285-7090 F. (972) 488-1816 2 40 V 4 4IAES VSt3 01 6~ Spine STS (K083894), the DePuy/AcroMed Brantigan Cage (P960025) and the Advanced Medical Technologies Distractable Wave Cage (K083626). P…
4-Web Spine, LLC2011—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…488-1816 2 40 V 4 4IAES VSt3 01 6~ Spine STS (K083894), the DePuy/AcroMed Brantigan Cage (P960025) and the Advanced Medical Technologies Distractable Wave Cage (K083626). Performance Testing: Preclinical testing…
Depuy Spine, Inc.1999—
*K083626Distractable Wave Cage
Summary page 2
…3 01 6~ Spine STS (K083894), the DePuy/AcroMed Brantigan Cage (P960025) and the Advanced Medical Technologies Distractable Wave Cage (K083626). Performance Testing: Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included static co…
Advanced Medical Technology, Inc.2009—

Also cleared against K083894: 4 other devices →

What descends from it? (537)

See all 537

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

NumberDeviceApplicantDecidedDescendants
K150481Cascadia Interbody SystemK2m, Inc.2015459
K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211
K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235
K1421124WEB Spinal Implant Products4Web, Inc.201433
K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711
K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810
K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175
K153436LATERAL Spine Truss System4Web, Inc.20165
K170341Medussa-PL CageMedyssey USA, Inc.20174
K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 29, 2014Class IIZ-0812-2015Labeling mix-upsProduct is mislabeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K150481 (K2m, Inc., 2015) has gone furthest, with 459 descendants of its own.
  • 4 other devices also cite its predicate K083894.

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-S1. 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 autograft 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 K083894

4 other devices cite the same predicate.

  • K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
  • K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
  • K153436LATERAL Spine Truss System4Web, Inc. · 2016
  • K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012

More from 4-Web, Inc.

3 FDA decisions under this applicant name. See the company

  • K1301854WEB Osteotomy Bone Wedge4-Web, Inc. · 2013
  • K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012

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/K112316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112316: 4-Web Alif Spinal Truss System (STS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112316

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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