510(k) · Cleared
ClearedLumbar Spine Truss System - Plating Solution (LSTS-PS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 12, 2026 as substantially equivalent to K203065 (4Web, Inc., 2021) after a 139-day review. Its family tree reaches back 11 generations to 1999.
- Decided
- Feb 12, 2026
- Review
- 139 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K990745 (1999). 133 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 2 generations backK190016 Lateral Plate SystemCorelink, LLC · 2019
- 1 generation backK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- This deviceK253201 Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 5 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 4 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 3 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 2 generations backK190016 Lateral Plate SystemCorelink, LLC · 2019
- 1 generation backK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- This deviceK253201 Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −5 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −4 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −3 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| −2 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| −1 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| 0 (this device) | K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2017 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)Summary page 5…nd the 1-hole, 2-hole, and 4-hole integrated plates. Predicate Device(s): The primary predicate device is the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) (K203065). A reference predicate is the Zimmer Biomet (Lanx) Timberline MPF (Lanx Spinal Fixation System) (K131547). Device Description:… | 2021 |
| † | K131547 | Lanx Fusion System | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 133 ancestors have a recall of any class.
- 5 other devices also cite its predicate K203065.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Lumbar Spine Truss System Plating Solution (LSTS-PS) non-integrated plate is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral, anterolateral, or…
Read the full statement (210 words)
The Lumbar Spine Truss System Plating Solution (LSTS-PS) non-integrated plate is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral, anterolateral, or anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The LSTS-PS integrated plate may be attached and remain attached to a Lateral Spine Truss System (LSTS) Interbody Fusion Device or an Anterior Spine Truss System (ASTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS integrated plate is intended to be used with supplemental fixation (e.g. posterior fixation).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253201: Lumbar Spine Truss System - Plating Solution (LSTS-PS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253201
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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