# K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Mar 20, 2015 after 88 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: 5 generations back to K922087 (1992). 21 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122733: V2F Anterior Fixation System, Zimmer Spine, Inc. (2012) Summary page 18.
- K111796: Invizia Anterior Cervical Plate System, Zimmer Spine, Inc. (2011) Summary page 18.
- K052072: The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates, Abbott Spine, Inc. (2005) Summary page 18.
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System, Spinal Concepts, Inc. (1999) Summary page 18.
- K013979: SC-Acufix Thinline Anterior Cervical Plate System, Spinal Concepts, Inc. (2002) Summary page 18.
- K140611: Trinica Anterior Lumbar Plate System, Zimmer Spine, Inc. (2014) Summary page 18.
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System, Zimmer Spine, Inc. (2013) Summary page 18.

## Most influential descendants
- K192481: AccelFix Lumbar Plate System (2020), 13 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (2022), 6 descendants of its own
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (2023), 3 descendants of its own
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (2023), 2 descendants of its own

## Indications for use
The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 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, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion. . The Trinica® and Trinica® Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K143626
Methodology: https://510kreport.com/methodology