510(k) · Cleared
ClearedAnterior Spine Truss System (STS) Interbody Fusion Device
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 Aug 7, 2017 as substantially equivalent to K112316 (4-Web, Inc., 2011) and 3 other predicates after a 138-day review. Its family tree reaches back 19 generations to 1984. 5 later devices descend from it.
- Decided
- Aug 7, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 273 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- This deviceK170851 Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
- Descendant · cites it directly · 1 of its ownK191134 IB3D AlifMedicrea International SA · 2019
- Descendant · 2 generations on · 0 of its ownK234087 restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024
- Descendant · 2 generations on · 0 of its ownK223326 Axiom PSR SystemRestor3D · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK200316 UNiD IB3D ALIFMedicrea International SA · 2020
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 1 generation backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- This deviceK170851 Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022 · cites it directly2descendants
- K191134IB3D AlifMedicrea International SA · 2019 · cites it directly1descendant
- K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024 · 2 generations on0descendants
- K223326Axiom PSR SystemRestor3D · 2023 · 2 generations on0descendants
- K200316UNiD IB3D ALIFMedicrea International SA · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −1 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| 0 (this device) | K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 4Web, Inc. | 2017 | — |
| +1 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | — |
| +1 | K191134 | IB3D Alif | Medicrea International SA | 2019 | — |
| +2 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024 | — |
| +2 | K223326 | Axiom PSR System | Restor3D | 2023 | 1 |
| +2 | K200316 | UNiD IB3D ALIF | Medicrea International SA | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 25 | 0 |
| 2005 | 16 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 37 | 0 |
| 2009 | 25 | 0 |
| 2010 | 18 | 0 |
| 2011 | 21 | 0 |
| 2012 | 11 | 0 |
| 2013 | 15 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (4)
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 5…ce is available in a variety of sizes and lordotic angles to accommodate the patient’s anatomy. Predicate Device(s): The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924. Performance Standards: Performance testing has been completed per… | 2011 |
| * | K142112 | 4WEB Spinal Implant ProductsSummary page 5…d lordotic angles to accommodate the patient’s anatomy. Predicate Device(s): The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - St… | 2014 |
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 5…c angles to accommodate the patient’s anatomy. Predicate Device(s): The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and… | 2015 |
| * | K160924 | Amendia Interbody Fusion DevicesSummary page 5…accommodate the patient’s anatomy. Predicate Device(s): The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axia… | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 26 of the 273 ancestors have a recall of any class.
- Of its descendants, K220523 (Restor3D, 2022) has gone furthest, with 2 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. 2017, 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 Anterior Spine Truss System (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…
Read the full statement (106 words)
The Anterior Spine Truss System (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 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.
https://510kreport.com/device/K170851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170851: Anterior Spine Truss System (STS) 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/K170851
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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