510(k) · Cleared
ClearedLateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 12, 2019 as substantially equivalent to K120092 (Globus Medical, Inc., 2012) and 6 other predicates after a 160-day review. Its family tree reaches back 9 generations to 1999. 15 later devices descend from it.
- Decided
- Jun 12, 2019
- Review
- 160 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K990745 (1999). 131 ancestors in all, the oldest K792352 (1979). 15 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK150449 LITe Plate SystemStryker Corp. · 2015
- This deviceK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · cites it directly · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · 2 generations on · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231739 Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK241487 Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK150449 LITe Plate SystemStryker Corp. · 2015
- This deviceK190016 Lateral Plate SystemCorelink, LLC · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · cites it directly9descendants
- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · cites it directly3descendants
- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · 2 generations on3descendants
- K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023 · 2 generations on2descendants
- K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −1 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| 0 (this device) | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +1 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
| +1 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +2 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +2 | K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 | — |
| +2 | K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Number Model Name Type K120092 Plymouth Plate System Globus Primary K131533 CAYMAN… | 2012 |
| * | K131533 | Cayman MI Plate SystemSummary page 5…Model Name Type K120092 Plymouth Plate System Globus Primary K131533 CAYMAN K2M Additional K150449 LITe… | 2013 |
| * | K150449 | LITe Plate SystemSummary page 5…outh Plate System Globus Primary K131533 CAYMAN K2M Additional K150449 LITe Stryker Additional K091044 Accufit ALP System… | 2015 |
| * | K091044 | Spinal Usa Anterior Lumbar Plate SystemSummary page 5…K2M Additional K150449 LITe Stryker Additional K091044 Accufit ALP System Spinal USA (Precision Spine) Additional K082187 Valiant Anterior Lumbar… | 2009 |
| * | K082187 | Biomet Anterior Lumbar PlateSummary page 5…Stryker Additional K091044 Accufit ALP System Spinal USA (Precision Spine) Additional K082187 Valiant Anterior Lumbar Biomet Spine Additional Plate System K111866… | 2008 |
| * | K111866 | Nuvasive Anterior Lumbar Plate SystemSummary page 5…Precision Spine) Additional K082187 Valiant Anterior Lumbar Biomet Spine Additional Plate System K111866 Halo II Anterior Lumbar NuVasive Additional Plate System K163104… | 2011 |
| * | K163104 | Terrace™ Anterior Cervical Plate SystemSummary page 5…dditional Plate System K111866 Halo II Anterior Lumbar NuVasive Additional Plate System K163104 Terrace™ Anterior CoreLink, LLC Additional Cervical Plate System… | 2017 |
What descends from it? (15)
See all 153 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 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 12 of the 131 ancestors have a recall of any class.
- Of its descendants, K203065 (4Web, Inc., 2021) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K120092.
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. 2019, 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 CoreLink Lateral Plate System (LPS) 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 CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following…
Read the full statement (173 words)
The CoreLink Lateral Plate System (LPS) 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 CoreLink LPS 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.
Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190016: Lateral 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/K190016
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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