# K113044: Synthes Mirs - Pathway: 510(k) (Traditional) - Applicant: Synthes Spine - Decided: Dec 21, 2011 after 70 days - Product code: NKB (Thoracolumbosacral Pedicle Screw System) - Device class: 2 - Regulation: 21 CFR 888.3070 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K950697 (1995). 75 ancestors in all. 93 later devices descend from it; 3 cite it directly. 1 of 169 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K963045: Synthes (U.S.a.) Universal Sacral System, Synthes (Usa) (1997) Summary page 1. - K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1. - K992739: Click'x, Synthes Spine (2000) Summary page 1. - K030625: Spinal Concepts Inc. Pathfinder, Spinal Concepts, Inc. (2003) Summary page 1. - K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1. - K071174: Pathfinder System Polyaxial Pedicle Screws, Abbott Spine, Inc. (2007) Summary page 1. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1. - K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 1. - K111457: CD Horizon Spinal System, Medtronic Sofamor Danek (2011) Summary page 1. - K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1. - K093668: Synthes Matrix Mis Rods, Synthes (Usa) (2010) Summary page 1. - K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1. - K100634: Synthes Matrix System, Synthes (Usa) (2010) Summary page 1. - K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) Summary page 1. ## Most influential descendants - K120571: Synthes Uss Connector (2012), 74 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 - K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own ## Recalls of this device - Sep 7, 2012 · Class II · Z-0395-2014: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned - Sep 7, 2012 · Class II · Z-0396-2014: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned - Jun 18, 2012 · Class II · Z-0001-2013: Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has upd ## Indications for use The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-52/ilium), posterior hook fixation (TI1-5), or anterolateral fixation (T8I-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When treating patients with Degenerative Disc Disease (ODD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. When used with the 3.5 mm/6.Omm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.Omm parallel connectors, the Synthes Small Stature UISS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.Ommn parallel connectors, the Synthes Small Stature USS can be linked to the Synthes UISS 6.0 mm rod systems. When used with the 3.5 mm/6.Omm and 4.0 mmI6.Omm tapered rods, the Synthes USS 6.0mmn rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.Smm and 4.0 mmIS.5 mm tapered rods, Matrix or MIRS can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.Omm tapered rods, the Synthes UISS 6.0 mim rod systems can be linked to the Matrix System or MIRS. In addition, Synthes USS 6.0 min rod systems can be interchanged with all UISS 6.0 mm rods and transconnectors except Synthes 6.0 mim cobalt-chromium-molybdenumn alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS o 6.0 mmn Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix o 5.5 mm Rod System: Matrix, MIRS o 5.0 mm Rod System: UISS Small Stature CerviFix o 3.5 mim Rod Systems: CerviFix, Axon, Synapse o 4.0 mm Rod System: Synapse Source page: https://510kreport.com/device/K113044 Methodology: https://510kreport.com/methodology