# K090203: 5.5 Helical Flange Spinal System, Polaris Components

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Jul 30, 2009 after 184 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 K041449 (2004). 5 ancestors in all.
154 later devices descend from it; 8 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061441: Ebi 5.5 Helical Flange Spinal System, Ebi, L.P. (2006) Summary page 2.
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 2.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001)
- K081952: Synergy Spinal System (6.35 Polaris), Biomet Spine (2008) Summary page 2.
- K061563: Ebi Array Spinal System, Ebi, L.P. (2006) Summary page 2.

## Most influential descendants
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K103393: Polaris Spinal System (2011), 104 descendants of its own
- K110906: Apex Spine System (2011), 103 descendants of its own
- K113058: Tiger Spine System (2012), 81 descendants of its own
- K111957: Polaris Spinal System (2011), 76 descendants of its own

## Indications for use
The 5.5 Helical Flange 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 for 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 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous 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, 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. The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange 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/K090203
Methodology: https://510kreport.com/methodology