# K120571: Synthes Uss Connector - Pathway: 510(k) (Traditional) - Applicant: Synthes Spine - Decided: May 14, 2012 after 77 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: 8 generations back to K950697 (1995). 79 ancestors in all. 74 later devices descend from it; 2 cite it directly. 1 of 154 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. - K992739: Click'x, Synthes Spine (2000) Summary page 1. - K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1. - K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1. - K100634: Synthes Matrix System, Synthes (Usa) (2010) Summary page 1. - K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1. - K111358: Synthes Uss, Synthes Spine (2011) Summary page 1. - K113044: Synthes Mirs, Synthes Spine (2011) - K113149: Synthes Uss Connectors, Synthes Spine (2012) Summary page 1. ## Most influential descendants - 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 - K150896: Vitality Spinal Fixation System (2015), 19 descendants of its own ## Indications for use The Synthes UISS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (Ti-52/ilium), posterior hook fixation (Ti-L-5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature UISS, 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 lordlosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. When used with the 3.5 mm/6.0mm parallel connectors, the Synthes UISS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature UISS can be linked to the Synthes UISS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes UISS 5.5 mm rod systems can be linked to the Synthes UISS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes UISS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another. Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes UISS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes UISS 6.0 mm rod systems can be linked to the Synthes UISS 5.5 mm rod systems. In addition, Synthes UISS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes UISS 5.5 mm rod systems can be interchanged with all UISS 5.5 mm rods and transconnectors. Synthes USS * 6.0 mm Rod Systems: UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Panges, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, ClampFix * 5.5 mm Rod Systems: Matrix, MIRS * 5.0 mm Rod System: UISS Small Stature CerviFix * 3.5 mm Rod Systems: CerviFix, Axon, Synapse * 4.0 mm Rod System: Synapse Source page: https://510kreport.com/device/K120571 Methodology: https://510kreport.com/methodology