# K100685: Zodiac Polyaxial Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Jun 18, 2010 after 100 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: 6 generations back to K000319 (2000). 29 ancestors in all.
168 later devices descend from it; 8 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033090: Icon Polyaxial Pedicle Screw System, Alphatec Mfg., Inc. (2004) Summary page 2.
- K042673: Zodiac Polyaxial Spinal Fixation System, Alphatec/Nexmed (2004) Summary page 2.
- K051286: Zodiac Spinal Fixation System, Alphatec/Nexmed (2005) Summary page 2.
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2007) Summary page 2.
- K093077: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K133221: Arsenal Spinal Fixation System (2014), 150 descendants of its own
- K143149: Arsenal Spinal Fixation System (2015), 84 descendants of its own
- K152968: Arsenal Spinal Fixation System (2015), 83 descendants of its own
- K142499: Reline System (2014), 78 descendants of its own
- K143684: NuVasive Reline System (2015), 77 descendants of its own

## Indications for use
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. 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-iliac screw indications are limited to the sacrum-iliac crest only. 1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac 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 Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac 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 Spinal Fixation System, when used as a pedicle screw system is intended for: a. Patients receiving autograft or allograft bone. b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. 4. The Zodiac® Polyaxial Spinal Fixation 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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity), c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

Source page: https://510kreport.com/device/K100685
Methodology: https://510kreport.com/methodology