510(k) · Cleared
ClearedAviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 19, 2022 as substantially equivalent to K142237 (Stryker Corporation, 2015) and 6 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1999. 1 later device descends from it.
- Decided
- Oct 19, 2022
- Review
- 127 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K990745 (1999). 159 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 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 deviceK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- Descendant · cites it directly · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
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 deviceK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · cites it directly0descendants
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) | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| +1 | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 12 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K142237 | Aviator Anterior Cervical Plate (ACP) SystemSummary page 9…Q 5. UniVise™ Spinous Process Fixation Plate PEK Predicate Devices: Primary Predicate: Aviator® (K142237) Additional Predicates: LITe® Plate System (K150449)… | 2015 |
| * | K150449 | LITe Plate SystemSummary page 9…K Predicate Devices: Primary Predicate: Aviator® (K142237) Additional Predicates: LITe® Plate System (K150449) DynaTran™ (K083020) Reflex™ Hybrid (K062310, K063430)… | 2015 |
| * | K083020 | Stryker Spine Reflex Translational Anterior Cervical Plating SystemSummary page 9…Aviator® (K142237) Additional Predicates: LITe® Plate System (K150449) DynaTran™ (K083020) Reflex™ Hybrid (K062310, K063430) UniVise™ Spinous Process Fixation Pl… | 2009 |
| * | K062310 | Reflex Hybrid Acp SystemSummary page 9…ional Predicates: LITe® Plate System (K150449) DynaTran™ (K083020) Reflex™ Hybrid (K062310, K063430) UniVise™ Spinous Process Fixation Plate (K132968) PYRENEES, B… | 2006 |
| * | K063430 | Zero Profile Anterior Cervical Plate (Acp) SystemSummary page 9…dicates: LITe® Plate System (K150449) DynaTran™ (K083020) Reflex™ Hybrid (K062310, K063430) UniVise™ Spinous Process Fixation Plate (K132968) PYRENEES, BLUE RIDGE… | 2007 |
| * | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM)Summary page 9…DynaTran™ (K083020) Reflex™ Hybrid (K062310, K063430) UniVise™ Spinous Process Fixation Plate (K132968) PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN T… | 2013 |
| * | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…Summary page 9…PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN Thoracolumbar and Buttress Plate Systems (K182473) Device Description: The previously cleared devices consist of a variety of plate systems designed… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral… | 2023 | 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 23 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 18 of the 159 ancestors have a recall of any class.
- Of its descendants, K230424 (Omnia Medical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K142237.
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. 2022, 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 Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic…
Read the full statement (613 words)
The Aviator® Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
* Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Trauma (including fractures)
* Tumors
* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
* Pseudarthrosis
» Failed previous fusion
* Decompression of the spinal cord following total or partial cervical vertebrectomy
* Spondylolisthesis
* Spinal stenosis
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.
The DynaTran™ Anterior Cervical Plating System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
* Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Trauma (including fractures)
* Tumors
* Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
* Pseudarthrosis
» Failed previous fusion
* Decompression of the spinal cord following total or partial cervical vertebrectomy
* Spondylolisthesis
* Spinal stenosis
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine from C2 — T1. These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
* Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Decompression of the spinal cord following total or partial cervical vertebrectomy
* Trauma (including fractures)
* Tumors
* Deformities or curvatures (including kyphosis, lordosis or scoliosis)
* Pseudoarthrosis
» Failed previous fusions
* Spondylolisthesis
* Spinal stenosis
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and not intended for stand-alone use.
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/K221728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221728: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221728
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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