(28 days)
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.
The provided text does NOT contain information regarding the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria for an AI/ML medical device.
The document is a 510(k) premarket notification for a physical medical device called the "GEO Bone Screw System." It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K161904).
Therefore, I cannot provide the requested information. The document explicitly states:
"No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system."
This indicates that no new studies were conducted to prove this specific submission of the device met acceptance criteria, but rather it relies on prior testing of its predicate device and general design controls.
§ 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.