(70 days)
The Howmedica® Fully Threaded Screws are intended to be used for cross-locking of Howmedica's femoral, tibial and humeral locking nails and IM rods.
Howmedica's Locking Nail Systems consist of different styles of femoral, tibial and humeral nails. This line extension is to add a new type of cross-locking screw to be used with the currently marketed Grosse & Kempt® nails, Gamma® nails and Seidel™ nails cleared under various 510(k) notifications plus any future styles of stainless steel IM rods or nails. The new screw is 4.6 mm in diameter and is available in various lengths. It has a cortical buttress thread design for transverse cross-locking of IM nails. The screws are manufactured from medical grade stainless steel.
This document is a 510(k) premarket notification for a medical device: Howmedica® Fully Threaded Screw. It is a submission to the FDA seeking clearance to market the device.
The provided text does not include details about acceptance criteria, device performance, a study, or any of the specific information requested in your prompt regarding AI/algorithm performance. This type of FDA submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance metrics from a formal study with acceptance criteria as one might find for a novel AI device.
Therefore, I cannot extract the requested information from the provided input.
However, I can tell you that the device presented is a Howmedica® Fully Threaded Screw, intended for cross-locking of femoral, tibial, and humeral locking nails and IM rods. Its substantial equivalence is based on intended use, materials, design, and operational principles to existing predicate devices (Zimmer's Buttress Thread Screws and Zimmer's ZMS Recon Nail Cross-Locking Screw). The FDA cleared this device based on this equivalence, not on specific performance data presented in the format you described.
§ 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.