# K132603: Apex Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spinecraft, LLC
- Decided: Nov 20, 2013 after 92 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: 11 generations back to K990745 (1999). 165 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 191 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.
- K110906: Apex Spine System, Spinecraft, LLC (2011) 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.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 1.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 1.
- K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 1.
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System, Orthofix (2012) Summary page 1.
- K093294: Revere Stabilization System, Globus Medical, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K120969: AC Lens Branded Contact Lens Case, Arlington Contact Lens Services,Inc. (2012). Our reading of the summary gave K120969, FDA’s number for AC Lens Branded Contact Lens Case (Arlington Contact Lens Services,Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Tiger Spine System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K150417: Astra Spine System (2015), 21 descendants of its own
- K211323: ASTRA Spine System (2021), 12 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own
- K162786: PASS LP Spinal System (2017), 6 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 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-S1 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-SI 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 sacrafiliac 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, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). When used in a percutaneous, posterior approach with AIM 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 patents . Levels of fixation are for the thoracic, lumbar and sacral spine.

Source page: https://510kreport.com/device/K132603
Methodology: https://510kreport.com/methodology