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The Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.

The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.

The ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal Stenosis, 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor. 7. Pseudoarthrosis, and 8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 as well as CoCr alloy conforming to ISO 5832-12. The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities. 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal Stenosis. 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor. 7. Pseudoarthrosis, and 8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3. The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities. 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal Stenosis. 5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor. 7. Pseudoarthrosis, and 8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3. The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 during the navigation of polyaxial screws (T1-T3).

The AIS S4 Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.

The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in athroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endoprosthesis replacement surgery (such as total knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The software modules for the OrthoPilot® Next Generation consist of modules for both a knee suite and a hip suite.

The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and 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 Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

When used as an Intervertebral Body Fusion System: The T-Space Spinal Implant System are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The AIS T-Space Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The AIS T-Space Spinal Implant System implants can be used individually or in pairs. The AIS T-Space Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aesculap device.

The T-Space Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The implants are offered in a coated and uncoated version and a variety of shapes and sizes to meet the requirements of the individual patient anatomy. The uncoated PEEK version is manufactured from PEEK - Optima (per ASTM F2026). The coated version will be the same in design as the uncoated PEEK implant with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have tantalum radiographic markers per ASTM F-560.

Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. The Columbus Total Knee System, Columbus Revision Knee System are designed for use with bone cement.

The VEGA patella is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) that incorporates a wrought stainless steel radiographic marker. The VEGA patella is intended to articulate with the femoral and tibial components of the Columbus Total Knee System, Columbus Revision Knee Svstem or EnduRo Knee System. The VEGA patella is sterile and intended for single use only.

The OrthoPilot® Next Generation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for endacement surgery (such as total knee, revision knee, unicondylar knee, and total hip systems) and provides intraoperative measurement. It indicates angles and positions for implant placement.

Aesculap's OrthoPilot® Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), passive markers, power supply, various tagged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer can also accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.