(44 days)
Small bone fracture fixation. Fixation and stabilization of bones of the feet in case of a osteotomy or fusion, such as Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing wedge osteotomy, MPG-Arthrodesis as well as for the fixation of almost all common osteotomies of the first metatarsal.
The DuoThread™ Bone screw is a fully or partially threaded cannulated bone fixation screw with a threaded head. The screw is made of titanium alloy (Ti-6Al-4V) ASTM F-136 in 3 mm diameter and in lengths 10 mm to 34 mm (in 2 mm increments).
The provided text is a 510(k) premarket notification for a medical device called the Merete DuoThread™ Bone Screw. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.
However, the document does not contain information about acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. This type of submission, for a Class II medical device, often focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than extensive new clinical efficacy studies.
Specifically, the document states:
- Technological Characteristics: "The DuoThread™ bone screws are similar to legally marketed predicate devices listed above in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics."
This indicates that the submission relies on the established safety and effectiveness of predicate devices (Landos Scarf Thread-Head™ Head Screw and Zimmer Herbert Bone Screw) due to similar design, materials (titanium alloy ASTM F-136), and intended use.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The document is primarily a regulatory filing demonstrating substantial equivalence, not a detailed clinical study report with 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.