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The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Rear & Mid-foot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

The Vilex eZ-Staple Superelastic Bone Fixation Staple is a single-use bone fixation appliance intended to be permanently implanted. Super Elastic staples are compression staples made of shape memory nickel titanium alloy, Nitinol. Vilex will offer Monocortical Staples ranging in width from 10mm to 20mm with leg lengths ranging from 10mm to 20mm and Biocortical Staples ranging in width from 10mm to 18mm with leg lengths from 15x13 to 19x17.

Ankle Arthrodesis, Tibio-talo-calcaneal Arthrodesis

The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking cross screws for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in five diameters and various lengths in either 316L VM (ASTM 138) stainless steel or Ti6Al4V titanium alloy (ASTM 136). The FUZETM System is a modular system consisting of the implant, locking screws, and instrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufactured from identical materials (either stainless steel or titanium alloy, matching the implant). The targeting device is radio translucent, designed to lock into the FUZETM for the correct insertion of the locking screws. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins.

The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement. The Vilex cannulated metallic hemi implant is intended for single use only.

Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.

Hallux Limitus or Rigidus Resurfacing of Arthritic /Metatarsal joint To fixate, use cement or press fit without cement

The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."

The Vilex X-Fix is intended for external fixation with the following indications: 1. Stabilization of Fractures & Osteotomy 2. Rear & Mid-foot Foot Arthrodesis 3. Adult and Pediatric Leg Lengthening 4. Correction of Bone Deformity in Upper & Lower Extremities.

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Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

Flat foot, pronated subtalar joint.

The material used to manufacture this device is implant-quality titaniumTl6A4V alloy. The device is intended to remain implanted for a finite period of time. The implant is best device is ifitended to remain implanted for a minto for a minto for single use only.

The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use: Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.

The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.

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