# K111358: Synthes Uss - Pathway: 510(k) (Traditional) - Applicant: Synthes Spine - Decided: Nov 18, 2011 after 186 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: 6 generations back to K990745 (1999). 24 ancestors in all. 151 later devices descend from it; 6 cite it directly. 1 of 176 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K992739: Click'x, Synthes Spine (2000). Our OCR of the scanned summary read K982739, FDA’s number for Gynex Electrodes (Gynex Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Click’X”. - 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). Our OCR of the scanned summary read K100852, FDA’s number for Stryker Switchpoint Infinity 3 Control System, Model… (Stryker Communications). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes Matrix System”. - K103287: Synthes 6.0 Cocr and CPT TI-3 Rods, Synthes Spine (2011) Summary page 1. ## Cited in the summary but kept off the family tree - K983045: Amielle, Owen Mumford USA, Inc. (1998). Our OCR of the scanned summary read K983045, FDA’s number for Amielle (Owen Mumford USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes USS”. Kept off the family tree. Summary page 1. ## Most influential descendants - K143684: NuVasive Reline System (2015), 77 descendants of its own - K120571: Synthes Uss Connector (2012), 74 descendants of its own - K160989: NuVasive® Reline® System (2016), 67 descendants of its own - K133746: Polaris Spinal System (2014), 67 descendants of its own - K161014: NuVasive® Reline® System (2016), 48 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-LS). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes smail 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 Smail Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm red systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another. 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 transconnectors except Synthes 6.0mm 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, 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 CerviFix • 3.5mm Rod Systems: CerviFix, Axon, Synapse • 4.0mm Rod System: Synapse Source page: https://510kreport.com/device/K111358 Methodology: https://510kreport.com/methodology