# K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws

- Pathway: 510(k) (Special)
- Applicant: Nexxt Spine, LLC
- Decided: Jun 26, 2014 after 30 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K003155 (2001). 119 ancestors in all.
106 later devices descend from it; 4 cite it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090984: Inertia Pedicle Screw System, Nexxt Spine, LLC (2009) Summary page 3.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010)
- K132412: Inertia Mis Pedicle Screw System, Nexxt Spine, LLC (2013) Summary page 3.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 3.
- K131417: Facet Fixx, Nexxt Spine, LLC (2013) Summary page 3.
- K133475: Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2013) Summary page 3.

## Most influential descendants
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The InertiaTM Pedlicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fuision in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (TI to S2): severe spondylolisthesis (grades 3 and 4)of the LS-S I vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as a cervical intervertebral fusion device, the HONOUR"' devices are indicated for use at one level in the cervical spine, from C2-TI, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade®)Anterior Cervical Plate System). When used as a lumbar intervertebrall fusion device, the HONQURTh devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S 1, in skeletally mature patients who have had six months of -non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous graft and with supplemental fixation systems cleared for Use in the lumbar spinie (e.g., the Inertia® Pedicle Screw System). When used as a vertebral body replacement device, the HONOUR"" devices are indicated for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolurnbar spine (e.g.. the Inertia®)Pedicle Screw System). The Facet Fixx System is intended to stabilize the spine as an aid, to fiusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translanninar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Finx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: * Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies * Degenerative disease of the facets with instability * Trauma (i.e. fracture or dislocation) * Spondylolisthesis * Spondlylolysis * Pseudoarthrosis and failed previous fussion which are symptomatic or which may cause secondary instability or deformity The Struxxurem System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion, Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with'the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K141376
Methodology: https://510kreport.com/methodology