# K113149: Synthes Uss Connectors - Pathway: 510(k) (Traditional) - Applicant: Synthes Spine - Decided: Feb 1, 2012 after 100 days - Product code: MNI (Orthosis, Spinal Pedicle Fixation) - 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: 6 generations back to K990745 (1999). 25 ancestors in all. 93 later devices descend from it; 3 cite it directly. 1 of 119 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K962608: Synthes (U.S.a.) Universal Spinal Parallel Connector, Synthes (Usa) (1996) Summary page 1. - 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. - 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 ## Indications for use The Synthes USS are non-cervical spinal fixation devices intended for posterior pedlicle screw fixation (Ti -S2/ilium), posterior hock fixation (TI 1-5), or anterolateral fixation (T8-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 (DOD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mmn rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mmn parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mmn parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mmn rod systems. Whien used with the 5.5/6.0mmn extension connectors, Matrix can be linked to the Synthes USS 6.0mmn rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mmn rod systems to one another. When used with the 3.5/6.0mmn and 4.0/6.0mmn tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mmn Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mmn Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System. In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mmn cobalt-chromium-molybdenumn alloy and titanium grade 3 rods, which can only be used with Pangea. SvnthesUSS * 6.0mm 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 * 5.5mm Rod System: Matrix * 5.0mm Rod System: USS Small Stature CetviFIx * 3.5mm Rod Systems: GerviFix, Axon, Synapse/c * 4.0mm Rod System: Synapse Source page: https://510kreport.com/device/K113149 Methodology: https://510kreport.com/methodology