# K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 24, 2003 after 200 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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.
867 later devices descend from it; 21 cite it directly.
2 of 868 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
- K040442: Protex Stabilization System (2004), 551 descendants of its own
- K052069: Protex Stabilization System with Additional Componentes (2005), 549 descendants of its own
- K061202: Revere Stabilization System (2006), 547 descendants of its own

## Indications for use
Posterior Components When used as posterior pedicle screw fixation system in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components, and the Dual-Opening USS and Synthes Small Stature USS (which includes small stature), is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous spinal fusion, and pseudoarthrosis. When treating patient's with Degenerative Disc Disease (ODD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. In addition, in skeletally mature patients, the Synthes USS, including the Click'X and USS VAS components and the Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients) is intended for the treatment of severe spondylolisthesis (grade 3 and 4) of the L5-Sl vertebra in patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation are L3-S2/ilium. When used as a posterior non-pedicle screw fixation system, in skeletally mature patients, the Synthes USS, and the Dual-Opening and Small Stature USS (which includes small stature and pediatric patients) are intended for the treatment of degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease) fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Anterior Components When used as an anteriolateral system, in skeletally mature patients, the Synthes USS, Dual-Opening USS and Small Stature USS (which includes small stature and pediatric patients), is intended for anteriolateral screw and/or staple fixation for the following indications: degenerative disc disease (as defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion (levels T8-L5). In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFixTMSystem. When used with 5.0/6.0 mm parallel connectors the Small Stature USS can be linked to the USS and Dual-Opening USS.

Source page: https://510kreport.com/device/K022949
Methodology: https://510kreport.com/methodology