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The NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus. The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.

The BioSorbFX O/M 2.0/2.4 System is intended for use in trauma and reconstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface, maxilla and mandible, and in orthognathic and reconstructive procedures of the midface, maxilla or mandible. The BioSorbFX O/M 2.0/2.4 System stabilizes bone during healing, in conjunction with appropriate postoperative immobilization. Especially in mandible BioSorbFX O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF). The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in and are contraindicated for: 1. Mandibular tumor resection. 2. Situations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism). 3. Significant comminuted fractures, including significant bone loss; of the mandible. 4. Intermaxillary fixation without an appropriate external fixation by other means.

The BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation Systems consists of various place configurations, which are attached to the bone by 2.0, 2.4 and 2.8mm/threaded fasteners (i.c., screws) of various lengths. The specifications for the BioSprbFXTM O/M 2.0/2.4 System plates and fastencrs will require a self-reinforced copolymer derived from Llactide and D/L-lactide ("PLA copo."), which consists of 70 molar percent poly-L-lactide and 30 molar percent poly-D, L-lactide, with strength retention time 18-36 weeks. Properly used, in the presence of adcquate immobilization, absortuble BioSprtFX'"> O/M 2.0/2.4 System implants stabilize bone during healing. The BioSorbFX™ O/M 2.0/2.4 System implants gradually lose their strength during 18-36, weeks. Biodegradation takes place within two to three years. The BioSorbFX™ Ont 2.0/2.4 System includes an instrument set containing bone drills, bone taps, screwdrivers, plate benders and cheek retractors.

1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. 1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000) Lengths of implants are 14, 16, 18, 20 and 25 mm. - Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000) Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). - Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed. The modifications are: Amendment of new length, 14mm implant, into product line. - Modified design accordingly. -

Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing. This indication is completely identical with the previously cleared BioCuffM (K001378). The BioCuff C™ is not intended for use in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.

BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378). The device description of BioCuff C™ screw and washer combination is as follows: - Composed of poly-L/D-lactide copolymer - -Lengths 18, 28 and 36mm. - Diameter 6.0 mm - -Cannulation for 1.5mm K-wire The only modifications that were made are: - Cannulated design for easier installation of the product - Increased outer diameter - Minor design changes in head of the screw and washer accordingly - Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947). - Introduction of new reference numbers - Introduction of new trade name, BioCuff CTM

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Contour Meniscus Arrow™ is as follows. - Composed of poly-L/D-polylactide copolymer - Length 10, 13 and 16mm - Diameter 1.1mm

The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.