Search Results

The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. These devices are to be used with autograft and/or allograft.

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System, and PASS OCT Spinal System package inserts for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with stainless steel in the same construct. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the Infinity™ OCT System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, Infinity™ OCT System components should never be reused under any circumstances.

Medtronic Navigated Referencing Devices

Medtronic navigated referencing devices provide rigid fixation to patient anatomy and enables the assembly of a patient reference frame. Various types of instruments are available including spine referencing clamps and associated connections to maintain compatibility with current spine reference frames.

Medtronic navigated referencing devices are compatible with various Medtronic spinal implant systems including Medtronic computer assisted surgery systems, including, but not not limited to, StealthStation™ and/or Mazor™ systems, and Medtronic navigation reusable instruments. These instruments are also compatible with Medtronic's IPC™ Powerease™ System when connected to the Powerease™ Driver.

Medtronic navigated referencing devices are supplied as non-sterile reusable instruments. All devices should be cleaned and sterilized before use.

Medtronic navigated referencing devices are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in accessories. Accessories include cases, trays, lids, caddies, and modules fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic and neurological reusable instruments.

Medtronic Reusable Instruments and Accessories

Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/ Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.

Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

N/A

Ask a specific question about this device