Search Results

When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine. This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.

Gibralt Rod-to-Rod Cross Connectors represent a line extension to the Gibralt Spinal System. The Gibralt Spinal System is a top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors. Gibralt Spinal System devices are used by surgeons to immobilize and stabilize spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine. As with other Gibralt System cross-connectors, Gibralt Rod-to-Rod Cross Connectors are designed to increase the rigidity of Gibralt Spinal System constructs. Gibralt Rod-to-Rod Cross Connectors can be used at any point along a Gibralt Spinal System rod, where previous cross connectors can only be used at connection points in a system construct. This line extension is proposed to provide surgeons with additional options for stabilizing and/or immobilizing spinal segments as an adjunct to spinal fusion. Like all Gibralt Spinal System components, the proposed Gibralt Rod-to-Rod Cross Connectors are manufactured from titanium alloy per ASTM F136. All implantable Gibralt Spinal System components are provided non-sterile, and must be steam sterilized by the hospital prior to use.

The OPTETRAK Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

The proposed Optetrak Logic PSC Tibial Insert devices represent modifications to existing Optetrak Logic Total Knee System components (K093360). Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components. The proposed Logic PSC devices combine the articulating geometry and locking features of predicate Optetrak Logic posterior stabilized inserts with a central spine that is slightly thicker in the medial/lateral dimensions, intended to provide surgeons with an option for treating patients with minor ligament laxity by introducing 2°-3° more varus/valgus constraint than the predicate. The proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities: - . the same indications for use - . similar design features - . the same shelf life - are packaged and sterilized using the same materials and processes. .