510(k) · Cleared
ClearedLITe Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 20, 2015 as substantially equivalent to K142699 (Stryker Corporation, 2014) and 2 other predicates after a 28-day review. Its family tree reaches back 8 generations to 1999. 24 later devices descend from it.
- Decided
- Mar 20, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K990745 (1999). 43 ancestors in all, the oldest K922543 (1993). 24 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 1 generation backK142699 LITe Plate SystemStryker Corporation · 2014
- This deviceK150449 LITe Plate SystemStryker Corp. · 2015
- Descendant · cites it directly · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK220324 AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K190016Lateral Plate SystemCorelink, LLC · 2019 · cites it directly15descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 2 generations on9descendants
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · 2 generations on3descendants
- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · 3 generations on3descendants
- K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −1 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| 0 (this device) | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| +1 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +2 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +3 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +1 | K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K142699 | LITe Plate SystemSummary page 5…21 CFR §888.3060 Product Code KWQ Predicate Devices Primary Predicate: Stryker Spine, LITe® Plate System, K142699 Additional Predicate: Stryker Spine, CENTAUR™ Spinal System, K9943… | 2014 |
| * | K994347 | Centaur Spinal SystemSummary page 5…Stryker Spine, LITe® Plate System, K142699 Additional Predicate: Stryker Spine, CENTAUR™ Spinal System, K994347, K001844 Device Description The LITe® Plate System is an anterior/anterolateral/lateral plate system… | 2000 |
| * | K001844 | Modification to Centaur Spinal SystemSummary page 5…r Spine, LITe® Plate System, K142699 Additional Predicate: Stryker Spine, CENTAUR™ Spinal System, K994347, K001844 Device Description The LITe® Plate System is an anterior/anterolateral/lateral plate system… | 2000 |
What descends from it? (24)
See all 246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190016 | Lateral Plate System | 2019 | 15 |
| K220324 | AccuFit Lateral 2-Hole Plate | 2022 | 3 |
| K183214 | Raven Lumbar Plate System | 2019 | 2 |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior… | 2022 | 1 |
| K241175 | MiRus MoRe Lumbar Plating System | 2024 | 0 |
| K232256 | Alcantara Thoracolumbar Plate System | 2024 | 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 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K190016 (Corelink, LLC, 2019) has gone furthest, with 15 descendants of its own.
- 7 other devices also cite its predicate K142699.
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. 2015, 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 LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally…
Read the full statement (202 words)
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Pseudoarthrosis;
• Spondylolysis;
• Spondylolisthesis;
• Spinal stenosis;
• Tumors;
• Trauma (i.e. Fractures or Dislocation)
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
• Failed Previous Fusion
The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150449: LITe Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150449
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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