# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Oct 19, 2022 after 127 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K990745 (1999). 159 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142237: Aviator Anterior Cervical Plate (ACP) System, Stryker Corporation (2015) Summary page 9.
- K150449: LITe Plate System, Stryker Corp. (2015) Summary page 9.
- K083020: Stryker Spine Reflex Translational Anterior Cervical Plating System, Stryker Corp. (2009) Summary page 9.
- K062310: Reflex Hybrid Acp System, Stryker Spine (2006) Summary page 9.
- K063430: Zero Profile Anterior Cervical Plate (Acp) System, Stryker Spine (2007) Summary page 9.
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM), Stryker Spine (2013) Summary page 9.
- K182473: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems, K2m, Inc. (2018) Summary page 9.

## Most influential descendants
- K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K221728
Methodology: https://510kreport.com/methodology