# K110906: Apex Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Jul 26, 2011 after 117 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 10 generations back to K990745 (1999). 110 ancestors in all.
103 later devices descend from it; 3 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062513: Apex Spine System, Spinecraft, Inc. (2006) Summary page 1.
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer, Spinecraft, Inc. (2010) Summary page 1.
- K102488: Apex Spine System W/ Cocr Rods, Spinecraft, LLC (2010) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.
- K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 1.
- K103393: Polaris Spinal System, Biomet Spine (2011) Summary page 1.
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System, Biomet Spine (Aka Ebi, LLC) (2010) Summary page 1.
- K100438: Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System, Ebi, L.P. (2010) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1.

## Most influential descendants
- K113058: Tiger Spine System (2012), 81 descendants of its own
- K131250: Tiger Spine System (2013), 40 descendants of its own
- K151977: icotec Pedicle System (2016), 30 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K133369: Tiger Spine System (2014), 29 descendants of its own

## Indications for use
The APEX Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis). The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to Si), and for whom the device is intended to be removed after solid fusion is attained. The APEX Spine System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. Levels of fixation are for the thoracic, lumbar and sacral spine.

Source page: https://510kreport.com/device/K110906
Methodology: https://510kreport.com/methodology