(113 days)
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments. fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
The Arthrex Bio-Pins are manufactured using poly(L-lactide) and stainless steel in accordance with ASTM F138.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA clearance letter for the Arthrex Bio-Pin, which states that the device is substantially equivalent to predicate devices. It describes the device, its indications for use, and confirms FDA clearance but does not include details on specific acceptance criteria, study methodologies, or performance metrics.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.