(85 days)
The Howmedica® 3.7mm Fully Threaded Screws are intended to be used for crosslocking of Howmedica's intramedullary nails and IM rods.
Howmedica's Locking Nail Systems consist of different types of intramedullary nails/rods, cross-locking screws and end caps. This line extension is to add a smaller cross-locking screw for use with current Howmedica® IM rod and nail systems cleared under various 510(k) notifications plus any future styles of stainless steel IM rods or nails. The new screw is 3.7mm in diameter and is available in various lengths. It has a cortical buttress thread design for cross-locking of IM nails. The screws are manufactured from medical grade stainless steel.
This 510(k) summary describes a medical device, not an AI/ML diagnostic. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, and expert ground truth is not applicable in the context of an AI/ML device.
The document discusses the substantial equivalence of Howmedica's Fully Threaded Screws to legally marketed predicate devices based on intended use, materials, design, and operational principles. It is a traditional medical device submission for a physical implant, not a software-based diagnostic tool.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.