# K100952: Modification to Synthes Matrix System - Pathway: 510(k) (Special) - Applicant: Synthes Spine - Decided: Aug 5, 2010 after 121 days - Product code: NKB (Thoracolumbosacral Pedicle Screw System) - Device class: 2 - Regulation: 21 CFR 888.3070 - Recalls of this device: 2 (1 Class I) - 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. 314 later devices descend from it; 14 cite it directly. 2 of 332 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1. - K100634: Synthes Matrix System, Synthes (Usa) (2010). Cleared while this submission was under review Summary page 1. - K963045: Synthes (U.S.a.) Universal Sacral System, Synthes (Usa) (1997) Summary page 1. - K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1. - K992739: Click'x, Synthes Spine (2000) Summary page 1. - K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1. - K002517: Uss Vas, Synthes (Usa) (2000) Summary page 1. ## Most influential descendants - 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 - K113044: Synthes Mirs (2011), 93 descendants of its own ## Recalls of this device - Oct 23, 2014 · Class I · Z-0226-2015: Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduct - Mar 11, 2011 · Not classified · Z-3207-2011: Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a ## Indications for use The Synthes USS 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 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), 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 pedlicle 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 USS 6.0 mm rod systems. When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS56.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm 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. Synthes USS 6.0 mm 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, Clamp Fix 5.5 mm Rod System: Matrix 5.0 mm Rod System: USS Small Stature CerviFix 3.5 mm Rod Systems: CerviFix, Axon, Synapse 4.0 mm Rod System: Synapse Source page: https://510kreport.com/device/K100952 Methodology: https://510kreport.com/methodology