(44 days)
The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Small Cortex Screws:
The Osteo Small Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread with three cutting grooves. The thread diameter measures 2.5mm, and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 5mm in diameter. The Osteo Small Cortex Screws are available in lengths from 6mm to 40mm.
Mini Cortex Screws:
The Osteo Mini Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and are available either with or without a self tapping thread on the self tapping screws features one cutting groove. The thread diameter measures 1.5mm, and the root diameter measures 1.0mm. These bone screws have a conical head underside with a cross slot. The head measures 2.5mm in diameter. The Osteo Mini Cortex Screws with a self tapping thread are available in lengths from 8mm to 22mm. The Osteo Mini Cortex Screws without a self tapping thread are available in lengths from 6mm to 20mm.
Small Cancellous Screws:
The Osteo Small Cancellous Screws are fabricated from ASTM F-138-92 stainless steel. The thread diameter measures 4.0mm. and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 6mm in diameter. The Osteo Small Cancellous Screws are available in lengths from 10mm to 60mm.
Mini Cancellous Screws:
The Osteo Mini Cancellous Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread. The self tapping thread features one cutting groove. The thread diameter measures 2.2mm, and the root diameter measures 1.1mm. These bone screws have a flat head with a cross slot. The head measures 3.0mm in diameter. The Osteo Mini Cancellous Screws are available in lengths from 8mm to 22mm.
The provided document is a 510(k) Premarket Notification Summary for medical devices (bone screws) and does not contain information about acceptance criteria or a study proving that an AI or device meets acceptance criteria in the way typically seen for AI/software devices.
Instead, this document pertains to the regulatory clearance of physical medical devices (bone screws) based on their substantial equivalence to predicate devices, rather than performance metrics from a clinical study for AI.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance from this document, as it is not present in the context of AI/software performance. The document focuses on material, design, and intended use equivalence.
§ 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.