# K994121: Small Stature Uss

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 17, 2000 after 316 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.
942 later devices descend from it; 13 cite it directly.
1 of 943 devices in its family (counting itself) has 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
- K071668: Orthobiom Spinal System (2008), 582 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K081568: Antegra-T (2008), 472 descendants of its own
- K121815: Nuvasive Sage Lateral Plate System (2012), 469 descendants of its own
- K131723: Coroent Single Tab System (2013), 466 descendants of its own

## Indications for use
When used as a posterior pedicle screw fixation system, the Synthes Small. Stature USS s intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including smail stature) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the theracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliasis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrasis). In addition, the Synthes Small Stature USS is intended for treatment of severe spondylofisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including smalil stature) and pediatric 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 Tusian. The levels of pedicle screw fixation for these patients are L.3-82. When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Smail Stature USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar sgine. The anterior components of the Synthes Small Stature USS when used in skeletally mature patients (Including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar gcoliosis, pseudoarthrosis, and fracture or dislacation of the thoracolumbar spine-{levels 78-L.5), In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix System. When used with 5.0/6.0mm parallel connectors, the Synthes Small Stature USS c¢an be linked to the Universal Spinal System

Source page: https://510kreport.com/device/K994121
Methodology: https://510kreport.com/methodology