# K101112: Reliance Spinal Screw System - Pathway: 510(k) (Special) - Applicant: Reliance Medical Systems - Decided: Nov 4, 2010 after 197 days - Product code: KWP (Appliance, Fixation, Spinal Interlaminal) - Device class: 2 - Regulation: 21 CFR 888.3050 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 11 generations back to K853033 (1985). 142 ancestors in all. 7 later devices descend from it; 5 cite it directly. 0 of 150 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K081978: Reliance Spinal Screw System, Reliance Medical Systems, LLC (2009) Summary page 1. - K880215: TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal Rod, Warsaw Orthopedic, Inc. (1988) Summary page 1. - K072429: Modification to TSRH Spinal System, Medtronic Sofamor Danek (2007) Summary page 1. - K961633: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 1. - K063670: Modifications to CD Horizon Spinal System, Medtronic Sofamor Danek (2007) Summary page 1. - K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1. - K081252: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1. - K905184: Isola (TM) Spine System Top Entry Hook, Acromed Corp. (1991) Summary page 1. - K022285: Modification to Isola Spinal System, Depuyacromed (2002) Summary page 1. - K061520: Viper Spine System, Depuy Spine, Inc. (2006) - K073562: Modification to Viper Spine System, Depuy Spine, Inc. (2008) Summary page 1. - K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 1. - K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1. - K070973: Quantum Spinal System, Pioneer Surgical Technology (2007) Summary page 1. - K080518: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2008) Summary page 1. - K080792: K2M Cocr Rod, K2m, Inc. (2008) Summary page 1. - K042635: Denali Spine System, K2m, LLC (2005) Summary page 1. - K052404: Denali Deformity System, K2m, LLC (2006) Summary page 1. - K052398: Mesa Spinal System, K2m, LLC (2005) Summary page 1. - K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) - K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 1. - K984251: Xia Spine System, Howmedica, Inc. (1999) - K080928: Xia Spinal System, Stainless Steel Uni-Planar Screws, Stryker Spine (2008) Summary page 1. - K052847: Capless Pedicle Screw System, X-Spine Systems, Inc. (2005) Summary page 1. - K072282: Capless LI Pedicle Screw System, X-Spine Systems, Inc. (2007) Summary page 1. - K052123: Synthes Pangea System, Synthes (Usa) (2005) ## Most influential descendants - K123521: Reliance Spinal Screw System (2013), 5 descendants of its own - K110896: Reliance Spinal Screw System (2012), 5 descendants of its own - K152131: Reliance Spinal Screw System (2015), 4 descendants of its own - K162066: Reliance Spinal Screw System (2016), 3 descendants of its own - K210874: Reliance Spinal Screw System (2021), 2 descendants of its own ## Indications for use The Reliance Spinal Screw System is a pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mnature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation; scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reliance Spinal Screw System is also indicated for pedicle sctew fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used posteriorly, the Reliance Spinal Screw System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, defonrtities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The Reliance Spinal Screw System when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). When used in a percutaneous, posterior approach with MIS Instrumentation, the Reliance Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. Source page: https://510kreport.com/device/K101112 Methodology: https://510kreport.com/methodology