510(k) Report

510(k) · Cleared

Cleared

4-Web Cervical STS (Spinal Truss System)

K121741510(k) TraditionalCleared Oct 18, 2012127-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, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Oct 18, 2012 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 4 other predicates after a 127-day review. Its family tree reaches back 13 generations to 2001. 35 later devices descend from it.

Decided
Oct 18, 2012
Review
127 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
5

Its longest line of descent runs back 13 generations to K003155 (2001). 61 ancestors in all, the oldest K841189 (1984). 35 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2008: 5 other ancestors2001: 7 other ancestors2009: 1 other ancestor2003: 7 other ancestors1999: 2 other ancestors1996: 1 other ancestor2007: 4 other ancestors2002: 4 other ancestors2005: 4 other ancestors2004: 9 other ancestors1984: 1 other ancestor2000: 1 other ancestor2017: 5 descendants cleared2014: 1 descendant cleared2018: 4 descendants cleared2022: 3 descendants cleared2020: 2 descendants cleared2025: 4 descendants cleared2023: 7 descendants cleared2019: 3 descendants cleared2021: 2 descendants cleared2026: 1 descendant cleared2024: 3 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 2009K100889 · Endoskeleton TC · Titan Spine, LLC · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors4 generations back: 9 other ancestors5 generations back: 10 other ancestors6 generations back: 8 other ancestors7 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 12 descendants3 generations forward: 11 descendants4 generations forward: 8 descendants K100889 · Endoskeleton TC · Titan Spine, LLC · 2010K083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 2009K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations between
  3. 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  4. 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  5. 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
  6. This deviceK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
  7. Descendant · cites it directly · 33 of its ownK142112 4WEB Spinal Implant Products4Web, Inc. · 2014
  8. Descendant · cites it directly · 12 of its ownK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
  9. Descendant · 2 generations on · 10 of its ownK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
  10. Descendant · 2 generations on · 7 of its ownK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
  11. Descendant · cites it directly · 6 of its ownK172446 SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017
Show all 13 generations
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations backK012254 VBROsteotech, Inc. · 2001
  3. 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  13. 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
  14. This deviceK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2014: 12017: 52018: 42019: 32020: 22021: 22022: 32023: 72024: 32025: 42026: 1
2014high 7 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 35 · See all
  • K1421124WEB Spinal Implant Products4Web, Inc. · 2014 · cites it directly33descendants
  • K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018 · cites it directly12descendants
  • K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019 · 2 generations on10descendants
  • K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017 · 2 generations on7descendants
  • K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−12K012254VBROsteotech, Inc.2001—
−11K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−7K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−6K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−5K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−4K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
−2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—
−1K100889Endoskeleton TCTitan Spine, LLC2010—
0 (this device)K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.2012—
+1K1421124WEB Spinal Implant Products4Web, Inc.2014—
+1K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.2018—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.2019—
+2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.2017—
+1K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199920
200010
200170
200240
200370
200490
200540
200740
200850
200910
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201750
201840
201930
202020
202120
202230
202370
202430
202540
202610
FIG. 1 — Lineage of K121741, 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 ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (5)

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
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…bstantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAKIC (P980048), Phantom Plus Cage (K08280 1), Endoskeleton TC (K 100889) and for manufacturing and materials purposes, the 4-Web ALIIF STS (K(0…
Sulzer Spine-Tech2001—
*K082801Phantom Plus Cage System
Summary page 1
…viously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAKIC (P980048), Phantom Plus Cage (K08280 1), Endoskeleton TC (K 100889) and for manufacturing and materials purposes, the 4-Web ALIIF STS (K(083894, K 1123 16). === Page 2…
Us Spine2008—
*K100889Endoskeleton TC
Summary page 1
…has the same indications for use, design, function, and materials used. The predicate devices include the BAKIC (P980048), Phantom Plus Cage (K08280 1), Endoskeleton TC (K 100889) and for manufacturing and materials purposes, the 4-Web ALIIF STS (K(083894, K 1123 16).…
Titan Spine, LLC2010—
*K083894Alif Spinal Truss Interbody Fusion Device
Summary page 1
…dicate devices include the BAKIC (P980048), Phantom Plus Cage (K08280 1), Endoskeleton TC (K 100889) and for manufacturing and materials purposes, the 4-Web ALIIF STS (K(083894, K 1123 16). eCal LoF2 Performance Testing: Preclinical testing…
4-Web Spine, LLC2011—
*K1123164-Web Alif Spinal Truss System (STS)
Summary page 1
…evices include the BAKIC (P980048), Phantom Plus Cage (K08280 1), Endoskeleton TC (K 100889) and for manufacturing and materials purposes, the 4-Web ALIIF STS (K(083894, K 1123 16). eCal LoF2 Performance Testing: Preclinical testing performed…
4-Web, Inc.20111

Also cleared against P980048: 53 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K1421124WEB Spinal Implant Products4Web, Inc.201433
K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812
K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176
K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170

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 11 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 4 of the 61 ancestors have a recall of any class.
  • Of its descendants, K142112 (4Web, Inc., 2014) has gone furthest, with 33 descendants of its own.
  • 53 other devices also cite its predicate P980048.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against P980048

53 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K182477Cervical SpacerAdditive Implants, LLC · 2019
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

More from 4-Web, Inc.

3 FDA decisions under this applicant name. See the company

  • K1301854WEB Osteotomy Bone Wedge4-Web, Inc. · 2013
  • K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc. · 20111 recall

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K121741 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121741: 4-Web Cervical 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/K121741

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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