# K120928: Synthes Matrix System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: May 18, 2012 after 52 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: 14 generations back to K853033 (1985). 180 ancestors in all.
No later device cites it as a predicate yet.
1 of 181 devices in its family (counting itself) has 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.
- K111358: Synthes Uss, Synthes Spine (2011) Summary page 1.
- K992739: Click'x, Synthes Spine (2000) Summary page 1.
- K113044: Synthes Mirs, Synthes Spine (2011) Summary page 1.
- K031175: Click'x Monoaxial Screws and Hooks, Synthes (Usa) (2003) Summary page 1.
- K113149: Synthes Uss Connectors, Synthes Spine (2012) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.
- K110216: Expedium System, Viper System, Depuy Spine, Inc. (2011) Summary page 1.
- K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1.
- K092605: Xia 4.5 Spinal System, Stryker Spine (2009) Summary page 1.
- K093668: Synthes Matrix Mis Rods, Synthes (Usa) (2010) Summary page 1.
- K113529: CD Horizon Voyager Spinal System, Medtronic Sofamor Danek (2012) Summary page 1.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1.
- K100634: Synthes Matrix System, Synthes (Usa) (2010) Summary page 1.

## 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 mm/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/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 5.5 mm/6.0 mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5 mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0 mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another. When used with the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems. In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 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, ClampFix 5.5 mm Rod System: Matrix, MIRS 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/K120928
Methodology: https://510kreport.com/methodology