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For fracture fixation of small bones and small bone fragments including odontoid fractures.

The AIS Odontoid Fracture Fracture Fixation System is comprised of screws and instruments. The 4.0mm cortical screws are either a fully-threaded or partially threaded. They are offered in various lengths and will be non-sterile. The screws are manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3.

The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The AIS Modulift VBR System may be used with bone graft.

The AIS Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint. The devices are intended for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur - Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral ephiphysis - Patients suffering from disability due to previous fusion . - Patients with acute femoral neck fractures ♥ Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

Aesculap Plasmafit Pro Acetabular Cup System and Vitelene Insert is a modular hip prostheses system intended to be used in conjunction with a prosthetic femoral head and hip stem in total hip arthroplasty. Aesculap Plasmafit Pro consists of a cementless titanium acetabular cup, a highly crosslinked (B-75 kGv) ultra-high molecular weight polyethylene (UHMW-PE) vitamin E insert, 40mm Biolox® delta, 40mm ISODUR® heads and optional titanium screws. The hemispherical titanium cup with a slightly flattened dome is coated with a titanium plasma spray on the outer surface which aims to provide a high level of primary stability with its rough finish. Plasmafit Pro cups are available in three (3) similar designs only varying in the number of holes (0, 3, 5/7) around the apex. The number of holes are adapted for optional anchoring 6.5mm diameter titanium alloy screws that may be used to ensure primary stability. Plasmafit Pro anchoring screws are an option available separately in sizes 16mm to 68mm lengths. Vitelene is designed with a taper-fit to the interior surface of Plasmfit Pro cups. The vitamin E insert has been shown to be more resistant to oxidation than conventional UHMWPE. Characterization of the oxidation indices of aged (ASTM F2003) and un-aged Vitelene measured according to ISO 5834-4 did not decrease . Further, Vitelene remains resistant to oxidation after 5 million cycles of wear as demonstrated in testing performed in accordance to ISO 14242. Plasmafit Pro cups are available in sizes ranging from 40mm - 70mm. Plasmafit Pro Acetabular Cup System and Vitelene insert may be used with Aesculap Biolox® delta and ISODUR® (CoCrMo) 40mm ball heads along with the following cleared compatible components: Aesculap Hip Implant Systems Excia, Metha, Prevision, and Unisyn and cleared Aesculap femoral heads: Biolox® Option, Biolox® Forte, Biolox® Delta, and CoCrMo to offer several interoperative implant options taking into consideration different patient bone conditions.

The AIS S4 Cervical 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 pedicle screws (T1-T3).

The AIS S4 Cervical 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.

When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft. When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally 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. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.

The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.

The S4 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 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 S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

The Columbus REVISION Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity, or dysfunction persist, and for patients suffering from corrective valgus or varus deformity and moderate flexion contracture. The Columbus REVISION Knee System is designed for use with bone cement.

The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offers femoral and tibial augments as well as stems to provide options for use during reconstructive surgery, particularly revision cases. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE and the tibial mask which is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only. All components manufactured from CoCrMo are also available with a ZrN (Zirconium nitride) coating which has been cleared in Aesculap Columbus AS Knee submission (K071220) and described in cleared Columbus Revision submission (K083772).

The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical fixation in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is intended to be used as an adjunct to fusion in the 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 S4 Spinal System consists of polyaxial screws and monoaxial screws of varying in The SF Opinar Oystom "Oneice" or styles, rods of varying lengths, and fixed and various styles of rod connectors. All implant components are top loading and top tightening. The Styles of Four connectors: Annoufactured from Titanium alloy in accordance with 150 5832/3 and ISO 5832/2.