# K033090: Icon Polyaxial Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Mfg., Inc.
- Decided: Mar 26, 2004 after 179 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000319 (2000). 9 ancestors in all.
180 later devices descend from it; 10 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K001668: Global Spinal Fixation System, D.K.M. Co., Ltd. (2000) Summary page 2.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 2.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 2.

## Most influential descendants
- K051286: Zodiac Spinal Fixation System (2005), 176 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own
- K100685: Zodiac Polyaxial Spinal Fixation System (2010), 168 descendants of its own
- K133221: Arsenal Spinal Fixation System (2014), 150 descendants of its own
- K143149: Arsenal Spinal Fixation System (2015), 84 descendants of its own

## Recalls of this device
- Dec 9, 2010 · Class II · Z-0269-2013: The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.

## Indications for use
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). 2) The ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). 3) In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4) The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for: a. Patients having fractures of thoracic and lumbar spine. b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Source page: https://510kreport.com/device/K033090
Methodology: https://510kreport.com/methodology