510(k) · Cleared
Cleared4WEB Spinal Implant Products
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 23, 2014 as substantially equivalent to K112316 (4-Web, Inc., 2011) and 1 other predicate after a 50-day review. Its family tree reaches back 14 generations to 2001. 33 later devices descend from it.
- Decided
- Sep 23, 2014
- Review
- 50 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K003155 (2001). 62 ancestors in all, the oldest K841189 (1984). 33 later devices descend from it, 6 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
- This deviceK142112 4WEB Spinal Implant Products4Web, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- Descendant · 2 generations on · 10 of its ownK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK171351 Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK172446 SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017
- Descendant · cites it directly · 5 of its ownK170851 Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. · 2017
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
- This deviceK142112 4WEB Spinal Implant Products4Web, Inc. · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- 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 · cites it directly7descendants
- K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017 · cites it directly6descendants
- K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. · 2017 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −1 | K121741 | 4-Web Cervical STS (Spinal Truss System) | 4-Web, Inc. | 2012 | — |
| 0 (this device) | K142112 | 4WEB Spinal Implant Products | 4Web, Inc. | 2014 | — |
| +1 | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | 2018 | — |
| +2 | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | 2019 | — |
| +1 | K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | 4Web, Inc. | 2017 | — |
| +1 | K172446 | SPIRA-C Open Matrix Cervical Interbody | Camber Spine Technologies | 2017 | — |
| +1 | K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 4Web, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
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 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112316 | 4-Web Alif Spinal Truss System (STS)Summary page 4…, packaged products. Predicate Device(s): The 4Web Spinal Implant Products is substantially equivalent to the previously cleared 4Web Spinal Implant Products, ALIF STS (K112316) and the Cervical STS (K121741). Each device is the primary predicate device for the respective proposed change. Device Descript… | 2011 |
| * | K121741 | 4-Web Cervical STS (Spinal Truss System)Summary page 4…Device(s): The 4Web Spinal Implant Products is substantially equivalent to the previously cleared 4Web Spinal Implant Products, ALIF STS (K112316) and the Cervical STS (K121741). Each device is the primary predicate device for the respective proposed change. Device Description: The ALIF STS Interbody Fus… | 2012 |
What descends from it? (33)
See all 336 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 2018 | 12 |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | 2017 | 7 |
| K172446 | SPIRA-C Open Matrix Cervical Interbody | 2017 | 6 |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 2017 | 5 |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | 2017 | 1 |
| K180695 | FBC 921 (Alif) | 2018 | 0 |
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 13 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 4 of the 62 ancestors have a recall of any class.
- Of its descendants, K173159 (4Web, Inc., 2018) has gone furthest, with 12 descendants of its own.
- 10 other devices also cite its predicate K112316.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The ALIF STS 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…
Read the full statement (193 words)
The ALIF STS 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).
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.
https://510kreport.com/device/K142112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142112: 4WEB Spinal Implant Products.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142112
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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