# K093668: Synthes Matrix Mis Rods

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 9, 2010 after 102 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
No predicates in its family tree.
94 later devices descend from it; 3 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K113044: Synthes Mirs (2011), 93 descendants of its own
- 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

## Indications for use
The Synthes UISS (including Matrix, UISS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USSVNAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (Ti -S2/lium), a posterior hook fixation system (T1 -L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: 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 (DIDD), 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 UISS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix) can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). 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 (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature UISS can be linked to the Synthes USS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix). In addition, Synthes UISS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Ciick'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix) can be interchanged with all UISS 6.0 mm rods and transconnectors.

Source page: https://510kreport.com/device/K093668
Methodology: https://510kreport.com/methodology