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The TIGER TRACK® screw system is intended for small bone extremity and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile. The TIGER TRACK® screw system, diameters 3.5mm or smaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalangeal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication. The TIGER TRACK® screw system is not for spinal use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated

The TIGER TRACK® screw system is intended for single use only, and is available in a range of different diameters, lengths and materials depending on the indication. The TIGER TRACK® screw system has two categories of screws: self-compressive screws and non-compressive screws. The self-compressive screws have a distal and proximal thread, separated by a cylindrical shaft where the fracture or osteotomy line should be placed. The difference of pitch between the distal and proximal thread provides compression between both segments. The TIGER TRACK® snap-off Weil screw doesn't have a proximal thread, the compression is done by its head and the distal thread. The non-compressive screws have a full thread allowing surgeons to only link both segments without any compression. All devices of the TIGER TRACK® screws system are monobloc components. The TIGER TRACK® screw system PEEK range is manufactured dry with grades of PEEK (Zeniva ZA-500) per ASTM F-2026 from Solvay Advanced Polymers released with predicate K133036, Titanium range is made of alloyed Titanium ISO 5832-3 / ASTM F-136 and released with predicate K131722, Snap-off threaded pin HV18XX range is made of Cobalt Chrome according to the ISO 5832-7 / ASTM F-1058 and released with predicate K120739. The feature design of the TIGER TRACK® screw system is substantially equivalent to the design features of other devices previously cleared for market.

The TOEGRIP® is intended for toes for general use in skeletally mature individuals undergoing surgery limited to interdigital fusion. The TOEGRIP® device is intended to be permanently implanted without any other additional device as an intramedullary bone fastener device for toes or fingers. The TOEGRIP® device is indicated for small bone reconstruction limited to interdigital fusion of toes in the following cases, listed in random order: - . Rigid PIP joints deformities - . Rigid hammertoes deformities - . Claw toes deformities (PIP and DIP joints) - Revision hammertoes surgeries . - . Shortening osteotomies of the proximal phalanx

The TOEGRIP® device consists of a monobloc implant with three flexible prongs inserted intramedullary into each part of phalanx The prongs are linked by a T-shaped beam. The fixation concept is based on a press-fit contact due to its tapered shape and the sharp macrostructures once impacted. The TOEGRIP® device is intended for single use only, and is available in a range of 5 sizes with 3 possible degrees: 0°, 10° or 20°. The TOEGRIP® device is manufactured with material according to the ISO-10993, ZENIVA® PEEK. The feature design of the TOEGRIP® is substantially equivalent to the design features of other devices previously cleared for market.