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The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint. The Hintermann Series H2 is indicated as a total ankle replacement in primary of ankle joints damaged bv: - Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis) - Primary arthritis (e.g., degenerative disease) - Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant) The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union of the ankle arthrodesis, provided sufficient bone stock is present. Note: In the United States, this device is intended for cemented use only.

The Hintermann Series H2 Total Ankle System is a total ankle prosthesis designed to replace the ankle joint. The Hintermann Series H2 Total Ankle System includes the following implantable components. - H2 Tibial Component - H2 Tibial Polyethylene (PE) Inlay - Hintermann Series Talar Component The tibial and talar components are coated with plasma spray titanium on the cement contacting surfaces. These components are used together to address the indications as outlined.

The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).

The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients. The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase. All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.

The NITINEX Memory Compression Staple is intended for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The NITINEX Memory Compression Staple is a single-use bone fixation appliance intended to be permanently implanted. The implantation of the NITINEX Memory Compression Staple facilitates hand and foot bone fragment osteotomy fixation and joint arthrodesis. NITINEX Staples are compression staples made of shape memory nickel titanium alloy, nitinol. Vilex LLC will offer NITINEX Staples ranging in width from 8-mm to 30-mm with leg lengths ranging from 8-mm to 30-mm.

The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

OPTIX H2 Patient Specific Instrument System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Hintermann reusable instruments, facilitate the positioning of the Hintermann Series H2 Total Ankle implants. Vilex's OPTIX H2 PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports.

The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot). The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.

The REDEMPTION™ Beaming System, consisting of the REDEMPTION™ Beams and the REDEMPTION™ Nails, is a reconstruction solution providing various diameters of cannulated screws. The REDEMPTION™ Beams are provided in diameters of Ø5.0 mm, Ø6.5 mm, and Ø8.0 mm, and are cannulated and either partially or fully threaded. The Ø5.0 mm beams are available in 35 mm to 130 mm lengths (5 mm increments) and the Ø6.5 mm and Ø8.0 mm beams are available in 40 mm to 160 mm lengths (5 mm increments). The REDEMPTION™ Nails are provided in diameters of Ø7.5 mm and Ø8.2 mm and are partially threaded. The nails range in length from 50 mm (5 mm increments). The REDEMPTION™ Headless 3.5 mm screw can be used as a cross screw with the nail and are offered in lengths from 12 mm to 60 mm. All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, drill guides, implant inserters, implant drivers, and a targeting guide are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel and radel (plastic).

The Vilex External Fixation System is intended for external fixation with the following indications: - · Stabilization of Fractures & Osteotomy - Rear and Mid-foot Arthrodesis - · Adult and Pediatric Leg Lengthening - · Correction of Bone Deformity in Upper & Lower Extremities

The Dynex Micro® falls within the Vilex External Fixation System product line. The system consists of the following components: - Half pins and pins; - Guidewires; ● - External fixation rails; and ● - Instruments. The half pins are constructed from stainless steel (ASTM F138 LVM) and are provided in multiple diameters (2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 mm) and lengths (60 - 175 mm). The transfixation pins, also constructed from stainless steel, and are provided in three diameters (2.5, 3.0, and 5.0 mm) and two lengths (250 mm and 350 mm). Guidewires are available in 1.1 mm and 1.6 mm diameter configurations and range in length from 60 - 150 mm. The mini- and mono- rails are manufactured from stainless steel and aluminum and are provided in various sizes (100 - 300 mm) to accommodate variations in patient size. The Dynex Micro® components are used with general and dedicated surgical instruments such as drill guides, drills, drill sleeves, wrenches, pin inserters, guide wire holders, and removal tools.

The Vilex External Fixation System is intended for external fixation with the following indications: - Stabilization of Fractures & Osteotomy - Rear and Mid-foot Arthrodesis - Adult and Pediatric Leg Lengthening - Correction of Bone Deformity in Upper & Lower Extremities

The Dynex® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components: - Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches); - Half pins and wires (regular and HA coated); - Ball Markers for X-Ray; - External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and - Instruments (e.g. drills. drivers. tensioners. cutters, and benders). The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning. The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins. Both systems utilize the same external fixation assembly hardware and instruments. The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points. The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference. The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile. The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size. These components can be combined to create various frame assemblies. The instruments and ball markers for X-Ray are manufactured from stainless steel.