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 Mar 10, 2021 as substantially equivalent to K190016 (Corelink, LLC, 2019) after a 152-day review. Its family tree reaches back 10 generations to 1999. 9 later devices descend from it.
- Decided
- Mar 10, 2021
- Review
- 152 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K990745 (1999). 132 ancestors in all, the oldest K792352 (1979). 9 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 2 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 1 generation backK190016 Lateral Plate SystemCorelink, LLC · 2019
- This deviceK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK231739 Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK233966 Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253201 Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253200 Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 4 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 2 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 1 generation backK190016 Lateral Plate SystemCorelink, LLC · 2019
- This deviceK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · cites it directly3descendants
- K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023 · cites it directly2descendants
- K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc. · 2024 · 2 generations on1descendant
- K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc. · 2026 · cites it directly0descendants
- K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −4 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −2 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| −1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| 0 (this device) | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +1 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +1 | K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 | — |
| +2 | K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024 | — |
| +1 | K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026 | — |
| +1 | K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K190016 | Lateral Plate SystemSummary page 5…e patient’s anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy. Predicate Device(s): The primary predicate device is the CoreLink Lateral Plate System (K190016). Reference predicates include the 4WEB Lateral Spine Truss System (K172392), 4WEB Anterior Spine Truss System – Stand Alone (K20… | 2019 |
| † | K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | 2017 |
| † | K200002 | Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device | 2020 |
| † | K192760 | NuVasive Modulus XLIF Interbody System | 2019 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 2023 | 3 |
| K231739 | Cervical Spine Truss System (CSTS) | 2023 | 2 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 2026 | 0 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 2025 | 0 |
| K233735 | ADIRA™ Lateral Plate System | 2024 | 0 |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 2022 | 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 22 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 132 ancestors have a recall of any class.
- Of its descendants, K223362 (4Web Medical, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K190016.
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. 2021, 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) without integrated fixation 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 or anterolateral…
Read the full statement (204 words)
The Lumbar Spine Truss System Plating Solution (LSTS-PS) without integrated fixation 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 or anterolateral 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 with integrated fixation is intended to be attached and remain attached to the Lateral Spine Truss System (LSTS) 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 with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203065: 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 5, 2026. https://510kreport.com/device/K203065
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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