(58 days)
The Perry Nail device is indicated for stabilizing humeral fractures.
The Perry nail geometry consists of a tubular proximal region and a distal blade region. The tubular proximal region displays a 10° lateral bend and an upper portion of the tube with internal threads created to house one or two bone screw locking cannulated set screws. The device is designed to accept transfixing screws. The two proximally located transfixing screw holes allow ± 15° anterior/posterior inclination of either 6.5mm cancellous or 4.5mm cortical screws into the humeral head and trochanter fragments.
This looks like a 510(k) premarket notification for a medical device called the "Perry Nail," which is an intramedullary fixation rod for stabilizing humeral fractures.
However, the provided text does not contain any information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested.
The document is a summary of the device, its intended use, a comparison to a predicate device (Orthologic Orthonail), and the FDA's clearance letter for market. It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, which is a different regulatory pathway than providing specific performance study results against predefined acceptance criteria for a new, novel device.
Therefore, I cannot populate the table or answer your specific questions with the information provided. The document states "Performance Data" but then immediately follows with "The Perry nail device was predicated on the use of the Orthologic Orthonail," implying that the performance data relied on the predicate device's established performance rather than a new, detailed study for the Perry Nail's specific acceptance criteria.
If you have a different document that contains this information, please provide it.
§ 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.