(77 days)
Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking.
Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for interlocking Synthes Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a premounted peek sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 26 mm - 125 mm.
This document is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It details the device's classification, description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study results. This type of regulatory submission typically focuses on demonstrating equivalence to previously cleared devices rather than providing detailed clinical study results or performance metrics against defined acceptance criteria.
§ 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.