# K133746: Polaris Spinal System - Pathway: 510(k) (Traditional) - Applicant: Biomet Spine (Aka Ebi, LLC) - Decided: Mar 12, 2014 after 93 days - Product code: NKB (Thoracolumbosacral Pedicle Screw System) - Device class: 2 - Regulation: 21 CFR 888.3070 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 16 generations back to K003155 (2001). 319 ancestors in all. 67 later devices descend from it; 5 cite it directly. 1 of 387 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 2. - K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011) Summary page 2. - K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 2. - K964159: CD Spinal System, Sofamor Danek USA,Inc. (1997) - K980184: CD Spinal System, Sofamor Danek USA,Inc. (1998) - K000476: Modification to CD Spinal System, Medtronic Sofamor Danek, Inc. (2000) Summary page 2. - K120571: Synthes Uss Connector, Synthes Spine (2012) Summary page 2. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 2. - K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 2. - K003822: Isola Closed Dual Rod Connector, Depuyacromed (2001) Summary page 2. - K022285: Modification to Isola Spinal System, Depuyacromed (2002) Summary page 2. - K962984: Isola Pediatric Components, Acromed Corp. (1996) Summary page 2. - K905826: Isola Slotted Connect/Angled Slotted Connector, Acromed Corp. (1991) Summary page 2. - K090203: 5.5 Helical Flange Spinal System, Polaris Components, Ebi, L.P. (2009) Summary page 2. - K131615: Polaris Spinal System, Biomet Spine (Aka Ebi, LLC) (2013) - K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System, Biomet Spine (Aka Ebi, LLC) (2013) Summary page 2. - K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System, Biomet Spine (Aka Ebi, LLC) (2010) Summary page 2. - K091067: 5.5 Polaris Spinal System, Biomet Spine (2009) Summary page 2. - K090523: Polaris Spinal System, Ebi, L.P. (2009) Summary page 2. - K061441: Ebi 5.5 Helical Flange Spinal System, Ebi, L.P. (2006) Summary page 2. - K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012) - K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2. - K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2. ## Most influential descendants - K143248: Reform Pedicle Screw System (2014), 30 descendants of its own - K150856: Reform Pedicle Screw System (2015), 26 descendants of its own - K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own - K150896: Vitality Spinal Fixation System (2015), 19 descendants of its own - K151422: Reform Pedicle Screw System (2015), 19 descendants of its own ## Recalls of this device - Mar 12, 2015 · Class II · Z-2152-2015: Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. ## 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 Omega2I 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/K133746 Methodology: https://510kreport.com/methodology