# K031175: Click'x Monoaxial Screws and Hooks

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 14, 2003 after 214 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
928 later devices descend from it; 20 cite it directly.
2 of 929 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
- K082572: Uss Iliosacral, Uss Polyaxial (2008), 659 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K052151: Synthes Pangea Monoaxial System (2005), 562 descendants of its own
- K040442: Protex Stabilization System (2004), 551 descendants of its own
- K052069: Protex Stabilization System with Additional Componentes (2005), 549 descendants of its own

## Indications for use
The Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial, Dual Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as a posterior pedicle screw fixation systems (TI-S2), a posterior hook fixation systems (TI-L5), or as anterolateral fixation systems (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated 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, pseudoarthrosis, and failed previous fusion. 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 (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and Dual Opening USS can be linked to the Cervifix system. In addition, when used with 3 3 5 . 0 mm parallel connectors, the Synthes Small Stature USS, can be linked to the CerviFix System. When used with the 5.016.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X and USS VAS variable axis components), the Click'X Monoaxial and Dual Opening USS Systems. In addition, Synthes USS (including the Click'X and USS VAS variable axis components), Click'X Monoaxial and the Dual Opening USS can be interchanged with all USS 6.0mm rods and transconnectors.

Source page: https://510kreport.com/device/K031175
Methodology: https://510kreport.com/methodology