510(k) Report

510(k) · Cleared

Cleared

PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)

K143258510(k) TraditionalCleared Apr 9, 2015147-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

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

Cleared on Apr 9, 2015 as substantially equivalent to K112316 (4-Web, Inc., 2011) and 2 other predicates after a 147-day review. Its family tree reaches back 14 generations to 1984. 1 of the 292 devices in its family, counting itself, has a Class I recall. 211 later devices descend from it.

Decided
Apr 9, 2015
Review
147 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
3

Its longest line of descent runs back 14 generations to K841189 (1984). 80 ancestors in all. 211 later devices descend from it, 6 citing it directly. 1 of the 292 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 4 other ancestors2012: 1 other ancestor2009: 2 other ancestors2008: 6 other ancestors, 1 with a Class I recall11999: 2 other ancestors2010: 1 other ancestor2007: 8 other ancestors2006: 1 other ancestor2003: 9 other ancestors2001: 9 other ancestors1996: 2 other ancestors2005: 4 other ancestors2004: 9 other ancestors2002: 7 other ancestors2000: 1 other ancestor2016: 1 descendant cleared2020: 12 descendants cleared2017: 4 descendants cleared2022: 24 descendants cleared2018: 7 descendants cleared2019: 7 descendants cleared2021: 14 descendants cleared2025: 41 descendants cleared2026: 34 descendants cleared2023: 31 descendants cleared2024: 36 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K101302 · Aleutian Ibf System · K2m, Inc. · 2010K103169 · Aleuttian · K2m, Inc. · 2011K130699 · Aleutian Spinal System · K2m, Inc. · 2013K133614 · Aleutian Ibf System · K2m, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors, 1 with a Class I recall13 generations back: 14 other ancestors4 generations back: 17 other ancestors5 generations back: 11 other ancestors6 generations back: 6 other ancestors7 generations back: 6 other ancestors8 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 22 descendants3 generations forward: 30 descendants4 generations forward: 35 descendants5 generations forward: 38 descendants6 generations forward: 38 descendants7 generations forward: 26 descendants8 generations forward: 11 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K133614 · Aleutian Ibf System · K2m, Inc. · 2014K130699 · Aleutian Spinal System · K2m, Inc. · 2013K103169 · Aleuttian · K2m, Inc. · 2011K101302 · Aleutian Ibf System · K2m, Inc. · 2010K082698 · Aleutian Ibf System · K2m, Inc. · 2009K063399 · Aleutian Spacer System · K2m, Inc. · 2007K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK103169 AleuttianK2m, Inc. · 2011
  4. 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  5. 1 generation backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
  6. This deviceK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
  7. Descendant · cites it directly · 199 of its ownK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
  8. Descendant · 2 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
  9. Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
  10. Descendant · 2 generations on · 131 of its ownK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
  11. Descendant · 3 generations on · 130 of its ownK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 6 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 5 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 4 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. 3 generations backK103169 AleuttianK2m, Inc. · 2011
  13. 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  14. 1 generation backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
  15. This deviceK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015

Showing 5 of 211 descendants. See all descendants

Descendants cleared per year

2016: 12017: 42018: 72019: 72020: 122021: 142022: 242023: 312024: 362025: 412026: 34
2016high 41 (2025) · low 1 (2016)2026

Class I recalls in this family

  • K073202 Ardis Spacer2 generations back · 2008

Most influential descendants

Showing 5 of 211 · See all
  • K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · cites it directly199descendants
  • K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 2 generations on159descendants
  • K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
  • K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019 · 2 generations on131descendants
  • K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2020 · 3 generations on130descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K051454Aleutian Spacer SystemK2m, LLC2005—
−6K063399Aleutian Spacer SystemK2m, Inc.2007—
−5K082698Aleutian Ibf SystemK2m, Inc.2009—
−4K101302Aleutian Ibf SystemK2m, Inc.2010—
−3K103169AleuttianK2m, Inc.2011—
−2K130699Aleutian Spinal SystemK2m, Inc.2013—
−1K133614Aleutian Ibf SystemK2m, Inc.2014—
0 (this device)K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH20172
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH2017—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018—
+2K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019—
+3K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT…Eit Emerging Implant Technologies GmbH2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200270
200390
200490
200540
200610
200780
200861
200920
201010
201140
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201740
201870
201970
2020120
2021140
2022240
2023310
2024360
2025410
2026340
FIG. 1 — Lineage of K143258, 1984–2026Source: 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.

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

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
*K1123164-Web Alif Spinal Truss System (STS)
Summary page 5
…== Page 5 === Predicate Device(s): The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) is substantially equivalent to the Primary Predicate, the 4WEB ALIF STS (K112316). Additional predicates include the K2M Aleutian (K133614) and the Orthofix Forza (K103111). Performance Standards: Preclinical…
4-Web, Inc.20111
*K133614Aleutian Ibf System
Summary page 5
…STS and OLIF STS (Spine Truss System) is substantially equivalent to the Primary Predicate, the 4WEB ALIF STS (K112316). Additional predicates include the K2M Aleutian (K133614) and the Orthofix Forza (K103111). Performance Standards: Preclinical testing performed on the 4WEB PLIF STS, TLIF STS and OLIF…
K2m, Inc.2014—
*K103111Forza Spacer System
Summary page 5
…stem) is substantially equivalent to the Primary Predicate, the 4WEB ALIF STS (K112316). Additional predicates include the K2M Aleutian (K133614) and the Orthofix Forza (K103111). Performance Standards: Preclinical testing performed on the 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) included…
Orthofix, Inc.20111

Also cleared against K112316: 10 other devices →

What descends from it? (211)

See all 211

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

NumberDeviceApplicantDecidedDescendants
K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017199
K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177
K153436LATERAL Spine Truss System4Web, Inc.20165
K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222
K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181
K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200

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.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
  • 14 of the 80 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K170503 (Eit Emerging Implant Technologies GmbH, 2017) has gone furthest, with 199 descendants of its own.
  • 10 other devices also cite its predicate K112316.

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. 2015, 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 PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are 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 K112316

10 other devices cite the same predicate.

  • K180695FBC 921 (Alif)Fbc Device Aps · 2018
  • K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
  • K170341Medussa-PL CageMedyssey USA, Inc. · 2017
  • K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. · 2017
  • K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
  • K153436LATERAL Spine Truss System4Web, Inc. · 2016

More from 4Web, Inc.

13 FDA decisions under this applicant name. See the company

  • K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
  • K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device4Web, Inc. · 2020
  • K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
  • K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019

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/K143258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143258

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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