# K210275: Polaris Spinal System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Biomet Spine, Inc.
- Decided: Apr 2, 2021 after 60 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: 18 generations back to K003155 (2001). 347 ancestors in all.
No later device cites it as a predicate yet.
1 of 348 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141804: Polaris Spinal System - HA Coated, Biomet Spine, LLC (2014) Summary page 5.
- K140123: Polaris Spinal System -Translation Screw, Ebi, LLC (2014) Summary page 5.
- K151974: Polaris Spinal System, Biomet Spine (2015) Summary page 5.

## 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 and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS 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, Lineum 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/K210275
Methodology: https://510kreport.com/methodology