# K131615: Polaris Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Sep 4, 2013 after 93 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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: 15 generations back to K003155 (2001). 290 ancestors in all.
70 later devices descend from it; 4 cite it directly.
0 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012)
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011) Summary page 2.
- K110070: TSRH Spinal System, Medtronic Sofamor Danck USA, Inc. (2011) Summary page 2.
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System, Biomet Spine (Aka Ebi, LLC) (2013)
- K090203: 5.5 Helical Flange Spinal System, Polaris Components, Ebi, L.P. (2009) Summary page 2.

## Most influential descendants
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own
- K140123: Polaris Spinal System -Translation Screw (2014), 22 descendants of its own
- K173130: Reform® Midline Cortical Screw System (2017), 21 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 anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: 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, Scheuermann's disease, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion. The Ballista/Ballista II instruments are intended to be used with Ballista/Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications. For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach. The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Nextgen Altius OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

Source page: https://510kreport.com/device/K131615
Methodology: https://510kreport.com/methodology