# K090523: Polaris Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 1, 2009 after 125 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: 2 generations back to K901587 (1990). 16 ancestors in all.
156 later devices descend from it; 5 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081952: Synergy Spinal System (6.35 Polaris), Biomet Spine (2008) Summary page 2.
- K061441: Ebi 5.5 Helical Flange Spinal System, Ebi, L.P. (2006)
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 2.
- K950709: Synergy TI Anterior Spinal System, Cross Medical Products, Inc. (1995) Summary page 2.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K033312: Ebi Top Loading Mas Spinal Fixation System, Ebi, L.P. (2004) Summary page 2.
- K061563: Ebi Array Spinal System, Ebi, L.P. (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- K001143: Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter, Rochester Medical Corp. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own
- K103393: Polaris Spinal System (2011), 104 descendants of its own
- K100438: Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System (2010), 104 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own

## Indications for use
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated fir all 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion. The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis,lseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The Accuvision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.

Source page: https://510kreport.com/device/K090523
Methodology: https://510kreport.com/methodology