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The Osteomedics® Resorbable Small Fixation System is intended for use in selective trauma or for reconstructive procedures in the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures, and selective orthognathic surgery of the maxilla and chin. The Osteomedics® Resorbable Small Fixation System is intended to provide temporary stabilization and fixation of bone during the healing in conjunction with appropriate postoperative immobilization. The use is in both adult and pediatric patients' cases involving trauma or reconstruction.

The Osteomedics® Resorbable Small Fixation System, OsteoSorb® consists of a series of plates, screws, bone fasteners and meshes, which are made from poly (L-lactide-co-D, Llactide) 70: 30. The plates are designed in varying configurations and lengths, which are attached to the bone using screw or bone fastener fixation.

Normed Titanium Calcaneus Plating with Locking Screw System intended for use in Intra and extra -artcular fractures, joint depression, non-displaced and tonque type, multifragmentary fractures, stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of calcaneus bones. The system can be used in both adult and pediatric patients.

Normed Titanium Calcaneus Plating with Locking Screw System consists of a series of plates in varying length; small, medium, long which are attached to the calcaneus bone using screw fixation. The plates are available in 1.3 mm plate thickness and have fourteen threaded holes and can be contoured as needed to fit the specific anatomy. The plates can be used on both the right and left of the calcaneus. The selftapping 3.5 mm screw diameters will be available in two designs, standard screw without threaded head and screw with threaded head.

Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Normed Distal Radius Reconstruction System consists of a series of titanium plates in various shape and length in left and right curved configurations, which are attached to the bone using 2,7 mm diameter titanium bone screws. The plates are available in 8, 11, and 13 holes with 2.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.7 mm screw diameters will be available in hex-lock screw head designs, in sixteen length 8 through 38 mm long in 2mm intervals. A hand fixation table system is also available for the surgeon to rest the injured hand during the surgery.

Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint.

Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length. The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.

Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

Normed Titanium Rondo Fix Fusion Plate and Screw System consists of a series of convex/concave plates in various shape and length which are attached to the bone using screw fixation. The plates are available in 1.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.3 mm screw diameters will be available in two screw head designs, standard cross-lock and square lock.

The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton.

The Normed Titanium Osteotomy Plating System consists of titanium plates in two configurations, wedge and step, which are attached to the bone using screw fixation. The wedge plates are available in six lengths, namely, 3,4,5,6,7and 8 mm with 2.3 mm diameter screws extends from 10 to 28 mm long. The step plates are available in four lengths, namely, 3,4,5 and 6 mm with 3.5 mm diameter screws extends from 10 to 28 mm long. The plates screw holes are threaded and can accept locking screws with threaded and non-threaded screw head.

The intended use of the Normed Transport Distraction Device is described and is identical to the 510 (k) number K990140 in which, the Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: - Tumor Resections - Severe trauma which make continuous bone segments no longer possible . - Bone grafting defects . - Sever open mandibular fractures . - Facial deformity corrections

External Mandibular Fixator and/or Distractor

The intended use of the Normed Bi-Directional / Multi-Directional Jaw Distractor is identical to the description in the 510 (k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

The device intended to be introduced by Osteomedics® Inc., is the same identical product described in the 510 (k) number K952847. The manufacturer, product design, product material, manufacturing process, device description, product intend use, labeling 2 quality assurance procedures, sterilization, substantial equivalency information and operational principal is identical to the information available in the 510 (k) number K952847