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Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM 4.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated, · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™ 4.5, EXPEDIUM™ 5.5, EXPEDIUM™ 6.35, VIPER™ 2, VIPER™ SAI, VIPER PRIME™, EXPEDIUM VERSE™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. The CONDUIT™ LLIF Cages (>20 degrees) must be used with CONDUIT™ Lateral Switch Plate and supplemental fixation. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The purpose of this Traditional 510(k) is to seek marketing clearance for 22-degree and 30degree lordosis angled CONDUIT™ Lateral Lumbar Intervertebral Fusion (LLIF) Cages in the CONDUIT™ line of lumbar interbody cages with additional cage height of 14 to 18 mm. The CONDUIT™ line of lumbar interbody cages includes lordosis angles of 0, 8, and 16 degrees. The CONDUIT™ LLIF Cage is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with cancellous bone graft and/or corticocancellous bone graft materials, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The CONDUIT™ LLIF Cage is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation, either applied anteriorly or posteriorly (e.g., using posterior pedicle screws). The CONDUIT™ Lateral Switch Plate is an optional device that connects to the CONDUIT™ LLIF Cage and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The CONDUIT™ LLIF Cage is made from Ti-6A1-4V alloy (ISO 5832-3) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.