510(k) Report

510(k) · Cleared

Cleared

Posterior Spine Truss System (PSTS) Interbody Fusion Device

K171351510(k) TraditionalCleared Sep 8, 2017122-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 Sep 8, 2017 as substantially equivalent to K143258 (4Web, Inc., 2015) and 2 other predicates after a 122-day review. Its family tree reaches back 19 generations to 1984. 1 of the 264 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.

Decided
Sep 8, 2017
Review
122 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
3

Its longest line of descent runs back 19 generations to K841189 (1984). 256 ancestors in all. 7 later devices descend from it, 3 citing it directly. 1 of the 264 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 6 other ancestors2014: 11 other ancestors2016: 1 other ancestor2012: 10 other ancestors2011: 21 other ancestors2013: 12 other ancestors2010: 16 other ancestors2009: 25 other ancestors2008: 37 other ancestors, 1 with a Class I recall12001: 10 other ancestors1999: 2 other ancestors2007: 12 other ancestors2006: 7 other ancestors2005: 18 other ancestors2004: 23 other ancestors2003: 15 other ancestors2000: 1 other ancestor1996: 2 other ancestors2002: 8 other ancestors2019: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant 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) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K160924 · Amendia Interbody Fusion Devices · Amendia, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 26 other ancestors, 1 with a Class I recall14 generations back: 55 other ancestors5 generations back: 67 other ancestors6 generations back: 47 other ancestors7 generations back: 21 other ancestors8 generations back: 8 other ancestors9 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants K160924 · Amendia Interbody Fusion Devices · Amendia, Inc. · 2016K150788 · Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices · Meditech Spine, LLC · 2015K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · 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. · 1984−15−10−50
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 15 generations between
  3. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  4. 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
  5. 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  6. This deviceK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
  7. Descendant · cites it directly · 3 of its ownK210595 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar…Camber Spine Technologies, LLC · 2021
  8. Descendant · cites it directly · 1 of its ownK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  9. Descendant · 2 generations on · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
  10. Descendant · 2 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
  11. Descendant · 2 generations on · 0 of its ownK221324 ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
Show all 19 generations
  1. Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
  19. 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  20. This deviceK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2018: 22019: 12021: 12023: 12024: 12025: 1
2018high 2 (2018) · low 0 (2020)2026

Class I recalls in this family

  • K073202 Ardis Spacer3 generations back · 2008

Most influential descendants

Showing 5 of 7 · See all
  • K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC · 2021 · cites it directly3descendants
  • K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018 · cites it directly1descendant
  • K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · 2 generations on0descendants
  • K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 2 generations on0descendants
  • K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−18K990148Stackable Cage SystemDepuy Motech Acromed1999—
−17K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−16K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−15K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−14K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−13K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−12K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−11K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−10K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−9K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−7K121683Acculif TL CageCoalign Innovations, Inc.2012—
−6K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−5K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−4K141217Acculif TL and PL CageStryker Corporation20143
−3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−2K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral…Meditech Spine, LLC2015—
−1K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016—
0 (this device)K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.2017—
+1K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC2021—
+1K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.2018—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting2025—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC2024—
+2K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
2003150
2004230
2005180
200670
2007120
2008371
2009250
2010160
2011210
2012100
2013120
2014110
201560
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201910
202110
202310
202410
202510
FIG. 1 — Lineage of K171351, 1984–2025Source: 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
*K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)
Summary page 5
…K171351 Page 1 of 2 Predicate Device(s): The primary predicate device is the 4WEB PSTS (K143258). Additional predicates include K142112, and K160924. Performance Standards: Performance testing has been completed per the fol…
4Web, Inc.2015—
*K1421124WEB Spinal Implant Products
Summary page 5
…Page 1 of 2 Predicate Device(s): The primary predicate device is the 4WEB PSTS (K143258). Additional predicates include K142112, and K160924. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and…
4Web, Inc.2014—
*K160924Amendia Interbody Fusion Devices
Summary page 5
…Page 1 of 2 Predicate Device(s): The primary predicate device is the 4WEB PSTS (K143258). Additional predicates include K142112, and K160924. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axia…
Amendia, Inc.2016—

Also cleared against K143258: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213
K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181
K1803473d CageFims Co., Ltd.20190

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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 33 years and passes through 14 companies; a new generation was cleared every 10 months on median.
  • 29 of the 256 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K210595 (Camber Spine Technologies, LLC, 2021) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K143258.

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. 2017, 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 Posterior Spine Truss System (PSTS) 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…

Read the full statement (106 words)

The Posterior Spine Truss System (PSTS) 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. 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 K143258

5 other devices cite the same predicate.

  • K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
  • K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz · 2020
  • K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018
  • K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and…Eit Emerging Implant Technologies GmbH · 20172 recalls
  • 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/K171351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171351: Posterior Spine Truss System (PSTS) Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171351

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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