# K100634: Synthes Matrix System - Pathway: 510(k) (Traditional) - Applicant: Synthes (Usa) - Decided: Jul 1, 2010 after 118 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: 4 generations back to K990745 (1999). 16 ancestors in all. 316 later devices descend from it; 9 cite it directly. 2 of 333 devices in its family (counting itself) have 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. - K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1. - K052151: Synthes Pangea Monoaxial System, Synthes Spine Co.Lp (2005) Summary page 1. - K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1. - K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1. - K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1. - K001864: Synthes Cervifix System, Synthes Spine (2000) - K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 1. ## Most influential descendants - K100952: Modification to Synthes Matrix System (2010), 314 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 - K113149: Synthes Uss Connectors (2012), 93 descendants of its own ## Indications for use The Synthes UJSS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iliumn), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedlicle 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 lordlosis, Scheuermann's Disease), tumnor, 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 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes UISS 6.0 mm rod systems. When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can he linked to the CerviFix 3.5 min and 4.0 mm Systems, respectively. When used with the 3.5/5.5 min and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System. In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors. SynthesUS 6.0 mm Rod Systems: USS Side-Opening, LISS Dual-Opening, US5 VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, LI55 Polyaxial, US5 Iliosacral, ClanpFfix 5.5 mm Rod System: Matrix 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/K100634 Methodology: https://510kreport.com/methodology