510(k) · Cleared
ClearedLATERAL Spine Truss System
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 Jun 6, 2016 as substantially equivalent to K112316 (4-Web, Inc., 2011) and 3 other predicates after a 192-day review. Its family tree reaches back 15 generations to 1984. 1 of the 107 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jun 6, 2016
- Review
- 192 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 101 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 107 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- This deviceK153436 LATERAL Spine Truss System4Web, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
- Descendant · cites it directly · 1 of its ownK172392 Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc. · 2017
- 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 ownK211388 Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- This deviceK153436 LATERAL Spine Truss System4Web, Inc. · 2016
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022 · cites it directly2descendants
- K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc. · 2017 · cites it directly1descendant
- K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024 · 2 generations on0descendants
- K223326Axiom PSR SystemRestor3D · 2023 · 2 generations on0descendants
- K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| 0 (this device) | K153436 | LATERAL Spine Truss System | 4Web, Inc. | 2016 | — |
| +1 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | — |
| +1 | K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | 4Web, Inc. | 2017 | — |
| +2 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024 | — |
| +2 | K223326 | Axiom PSR System | Restor3D | 2023 | 1 |
| +2 | K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 12 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 1 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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.
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 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 4…The implant is made from Ti6Al4V alloy (ASTM F-1108). Predicate Device(s): The 4WEB LATERAL STS is substantially equivalent to the primary predicate, the 4WEB ALIF STS (K112316). Additional predicated devices are the 4WEB PSTS (K143258), 4WEB ALIF STS (K083894), and Medtronic Clydesdale Spinal System (K13… | 2011 |
| * | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)Summary page 4…icate Device(s): The 4WEB LATERAL STS is substantially equivalent to the primary predicate, the 4WEB ALIF STS (K112316). Additional predicated devices are the 4WEB PSTS (K143258), 4WEB ALIF STS (K083894), and Medtronic Clydesdale Spinal System (K132897). Performance Standards: Validated FEA, comparing the… | 2015 |
| * | K083894 | Alif Spinal Truss Interbody Fusion DeviceSummary page 4…LATERAL STS is substantially equivalent to the primary predicate, the 4WEB ALIF STS (K112316). Additional predicated devices are the 4WEB PSTS (K143258), 4WEB ALIF STS (K083894), and Medtronic Clydesdale Spinal System (K132897). Performance Standards: Validated FEA, comparing the subject device to PLIF S… | 2011 |
| * | K132897 | Clydesdale Spinal SystemSummary page 4…imary predicate, the 4WEB ALIF STS (K112316). Additional predicated devices are the 4WEB PSTS (K143258), 4WEB ALIF STS (K083894), and Medtronic Clydesdale Spinal System (K132897). Performance Standards: Validated FEA, comparing the subject device to PLIF STS (K143258), was conducted to evaluate the mechan… | 2013 |
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? (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 32 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 101 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2016, 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 Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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.
https://510kreport.com/device/K153436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153436: LATERAL Spine 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/K153436
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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