# K091067: 5.5 Polaris Spinal System

- Pathway: 510(k) (Special)
- Applicant: Biomet Spine
- Decided: Jul 14, 2009 after 91 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: 7 generations back to K950697 (1995). 48 ancestors in all.
79 later devices descend from it; 4 cite it directly.
0 of 128 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.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 2.
- K082942: Modfication to: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 2.
- K082608: Radius Spinal System, Vitallium Rod #486613601, Stryker Spine (2008) Summary page 2.

## Most influential descendants
- K111957: Polaris Spinal System (2011), 76 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K131343: Reform Pedicle Screw System (2013), 31 descendants of its own

## Indications for use
The 5.5 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 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 Polaris Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The 5.5 Polaris Percutaneous Instruments when used with the 5.5 Polaris Spinal System 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 Polaris Mini-Open Instruments, when used with the 5.5 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/K091067
Methodology: https://510kreport.com/methodology