(22 days)
The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.
These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.
This 510(k) summary describes a bone screw, which is a physical medical device, not an AI/ML enabled device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device based on material, indications for use, and similar thread form, which are criteria relevant to physical orthopedic implants.
§ 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.