# K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Feb 25, 2013 after 98 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K003155 (2001). 267 ancestors in all.
75 later devices descend from it; 5 cite it directly.
0 of 343 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.
- K090203: 5.5 Helical Flange Spinal System, Polaris Components, Ebi, L.P. (2009) Summary page 2.
- K111957: Polaris Spinal System, Biomet Spine (Ebi, LLC) (2011) Summary page 2.
- K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012)
- K120270: Venus Spinal Fixation System, L&K BIOMED Co., Ltd. (2012) Summary page 2.
- K100706: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2010) Summary page 2.
- K103085: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 2.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2.
- K112473: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2011)
- K102555: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 2.

## Most influential descendants
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- 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

## Recalls of this device
- Oct 8, 2014 · Class II · Z-0909-2015: Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
- Aug 22, 2013 · Class II · Z-0359-2014: Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

## 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. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or ailograft. 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/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion. The Ballista/Ballista 11 instruments are intended to be used with Ballista/Ballista Il/Polaris 5.5mmn implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista 11 instruments 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/or lordosis), tumor, stenosis, pseudoarthrosis, or 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 and/or allograft. 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, the Array Spinal System, the Biomet Omega2 1 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/K123549
Methodology: https://510kreport.com/methodology