# K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer

- Pathway: 510(k) (Special)
- Applicant: Spinecraft, Inc.
- Decided: Mar 16, 2010 after 186 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K944736 (1995). 20 ancestors in all.
178 later devices descend from it; 7 cite it directly.
0 of 199 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 2.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 2.
- K013296: Moss Miami Spinal Systems, Depuyacromed (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX, OraSure Technologies, Inc. (2001). Our reading of the summary gave K011057, FDA’s number for Intercept Oral Fluid Drug Test Oral Specimen Collection… (OraSure Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MONARCH Spine System”. Kept off the family tree.

## Most influential descendants
- K102488: Apex Spine System W/ Cocr Rods (2010), 177 descendants of its own
- 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

## Indications for use
The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 LS-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 5.5mm Rod and Polyaxial Screw Washers 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 (L_3 to sacrum) with removal of the implants after the attainment of a~solid fusion, The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 studfies); spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc. confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Source page: https://510kreport.com/device/K092825
Methodology: https://510kreport.com/methodology