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RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred. The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults. The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.

The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred. The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.

The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly. Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat. The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm. The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization. The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.