# K102488: Apex Spine System W/ Cocr Rods

- Pathway: 510(k) (Special)
- Applicant: Spinecraft, LLC
- Decided: Dec 10, 2010 after 101 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: 9 generations back to K990745 (1999). 60 ancestors in all.
177 later devices descend from it; 7 cite it directly.
0 of 238 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.
- K092610: Modification to Beacon Stabilization System, Globus Medical, Inc. (2009) Summary page 2.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 1.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 2.
- K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1.

## Most influential descendants
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own
- K113058: Tiger Spine System (2012), 81 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 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 neurological impairment, fracture, dislocation, scoliosis, kylphosis, spinal tumor, and failed previous fusion (pseudo-arthrosis). The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The APEX Spine System is also a hook and 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).

Source page: https://510kreport.com/device/K102488
Methodology: https://510kreport.com/methodology