# K103287: Synthes 6.0 Cocr and CPT TI-3 Rods - Pathway: 510(k) (Special) - Applicant: Synthes Spine - Decided: Jan 5, 2011 after 65 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: 5 generations back to K990745 (1999). 17 ancestors in all. 348 later devices descend from it; 8 cite it directly. 1 of 366 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1. - K052151: Synthes Pangea Monoaxial System, Synthes Spine Co.Lp (2005) Summary page 1. - K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1. - K992739: Click'x, Synthes Spine (2000) Summary page 1. - K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1. - K963045: Synthes (U.S.a.) Universal Sacral System, Synthes (Usa) (1997) Summary page 1. - K090605: Clampfix, Synthes (Usa) (2009) Summary page 1. ## Most influential descendants - K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own - K122226: Revere Stabilization System (2012), 225 descendants of its own - K124058: Creo Stabilization System (2013), 172 descendants of its own - K143633: CREO Stabilization System (2015), 158 descendants of its own - K111358: Synthes Uss (2011), 151 descendants of its own ## Indications for use The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), 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 (DDD), 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 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm 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 4.0mm 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 tmansconnectors except Synthes 6.0 tur cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Glick'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix 5.5min Rod System: Matrix 5.0mm Rod System: USS Small Stature Cervix 3.5mm Rod Systems: CerviFix, Axon, Synapse 4.0mm System: Synapse Source page: https://510kreport.com/device/K103287 Methodology: https://510kreport.com/methodology