# K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Oct 8, 2020 after 55 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: 6 generations back to K032037 (2003). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092765: Lanx Anterior Plating System, Lanx, Inc. (2010) Summary page 10.
- K100805: Gallery Laminoplasty Fixation System, Biomet Spine (Aka Ebi, LLC) (2010) Summary page 10.
- K101364: Lanx Facet Screw System, Lanx, Inc. (2010) Summary page 10.
- K131156: Lanx Spinal Fixation System, Lanx, Inc. (2013) Summary page 10.

## Indications for use
The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic, lumbar, and/or sacral spine (T1-81) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities: * Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spinal Stenosis (indicated for L1-S1 only); * Spondylolisthesis; * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); * Trauma (i.e., fracture, dislocation, or subluxation); * Spondylolysis; * Tumor; * Pseudoarthrosis; and/or * Failed previous fusion The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels. The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord. The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following: * Pseudoarthrosis and failed previous fusions; * Spondylolisthesis; * Spondylolysis; * Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; * Degeneration of the facets with instability and; * Trauma including spinal fractures and/or dislocations. The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Alpine XC Adjustable MIS Fusion System 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 Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use. The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Aspen device 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 Aspen device is intended for use with bone graft material, not intended for stand-alone use. The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft. The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The LPlate device 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 LPlate device is intended for use with bone graft material, not intended for stand-alone use.

Source page: https://510kreport.com/device/K202309
Methodology: https://510kreport.com/methodology