(206 days)
CAPTIVATE™ Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.
CAPTIVATE™ VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.
CAPTIVATE™ Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE™ implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138.
This document is a 510(k) premarket notification summary for CAPTIVATE™ Compression Screws. It describes the device and its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in human clinical performance metrics.
The "Performance Data" section discusses mechanical testing of the device (bending strength, torsional strength, driving torque, pullout testing, cyclic bending, and bacterial endotoxin testing). This type of testing is typically done to ensure the physical integrity and safety of the device itself, rather than to evaluate its performance in a clinical setting against specific clinical acceptance criteria for human outcomes.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially concerning clinical performance, AI performance, MRMC studies, or standalone algorithm performance) cannot be extracted from the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through similar technological characteristics and laboratory-based mechanical performance data.
§ 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.