# K020517: Synthes Dual-Opening Uss

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Apr 15, 2002 after 55 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 4, 2015 · Class II · Z-0134-2016: This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Bla
- Jun 5, 2013 · Class II · Z-1935-2013: DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specific
- May 31, 2012 · Class II · Z-2054-2012: USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498

## Indications for use
When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS and the Dual-Opening USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small 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 fusion. The levels of pedicle screw fixation for these patients are L3-S2. When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Dual-Opening USS are intended for 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 spine. The anterior components of the Synthes Small Stature USS and the Dual-Opening 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 scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System and the Dual-Opening USS.

Source page: https://510kreport.com/device/K020517
Methodology: https://510kreport.com/methodology