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The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.

The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm.

The Instratek 4.5mm, 5.5mm, and 6.5mm screws are indicated for fixation of bone fractures, osteotomies, non-unions and mal-unions in bone reconstruction. These devices are not intended for use in the spine. The Instratek 4.5mm, 5.5mm, and 6.5mm screws are intended for the following surgical indications: - Metatarsal fractures - Fixation of malunions and nonunions - Acute fractures - Avulsion fractures - Repetitive stress fractures - Malleolar fractures - Talus fractures - Greater tuberosity fractures - Small joint fusion - Jones fractures - Osteotomies and non-unions in the foot and ankle

The Instratek Jones-FX System is comprised of screws in diameters 4.5mm, 5.5mm and 6.5mm. The screws are available in cannulated and non-cannulated versions and are constructed of TI-6AL-4V anodized titanium alloy conforming to ASTM F136. The screws have Torx heads. Instruments provided in the set include: Tissue protector K-wire guides Drill guide inserts (3.1mm, 4.0mm and 4.9mm) Tap Guide inserts (4.5mm, 5.5mm and 6.5mm) K-wire (1.7mm x 230mm) Cannulated drill bits (3.1mm, 4.0mm and 4.9mm) Screw Taps, Cannulated (4.5mm, 5.5mm, 6.5mm) Depth gauge Driver blade Fixed and Rachet Quick Connect Drivers Countersink Tray with Caddy

The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine. The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications: • Scaphoid Fractures • Capitate • Metacarpal Fractures • Phalangeal Fractures • Ulnar Styloid Fractures • Small Joint Fusion • Humeral head Fractures • Intercarpal Fractures • Tarsal Fusions • Patellar Fractures • Interfragmentary Ulnar Fractures • Small Hand and Wrist Bone Fractures • Forefoot Interfragmentary Fractures • Lunate Fractures • Trapezial Fractures • Metatarsal Fractures • Radial Head Fractures • Osteo-Chondral • Ostero-Chondral Fractures • Glenoid Fractures • Interphalangeal Fractures • Malleolar Fractures • Metaphyseal Fractures • Interfragmentary Radius Fractures • Distal Metatarsal Osteotomies • Midfoot Interfragmentary Fractures

The Instratek Mini Cannulated Titanium Headed and Headless Screw Set is comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy. The screws have Torx heads. Instruments provided in the set include drivers (fixed and rotating) and blades, countersink/depth gauge, screw pickup, drill bits, threaded and unthreaded kwires and a caddy/tray.

The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability.

The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. The implanted device consists of three (3) components: Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device: Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing

The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.

The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle. Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components: Medial Plate, Lateral Plate, Suture. There are 6 accessories required to implant the device: suture lasso, kwire, cannulated drill bit, kwire guide, plate bender, suture scissor.

The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the biomechanical reduction of abnormal intermetatarsal angle. The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.

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The Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma. - Hypermobile pes valgus - Posterior tibial tendon dysfunction - Severe pronation - Subtalar instability - Hypermobile flexible congenital flat foot

The Instratek Sub-Talar Lok Implant is designed to stabilize the subtalar joint of the hyperpronated foot. The implant is conical shaped with external threads of uniform depth and pitch. The device is cannulated for use with a guide wire. The product will be provided with a procedure kit containing: Five (5) dilators sized 7 through 11 mm Ten Sub-Talar Lok implants, two each of five sizes Regular driver, 4.3mm hex head Rescue driver, threaded