(97 days)
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
The provided document describes the Akros FibuLink™ Syndesmosis Repair Kit, a medical device for orthopedic fixation. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria based on clinical performance metrics is not detailed in this document.
The document focuses on non-clinical testing for substantial equivalence.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical testing was not performed or necessary for this 510(k) submission, there are no acceptance criteria related to clinical performance (e.g., sensitivity, specificity, accuracy). The document primarily outlines non-clinical testing results.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Simulated use | Adequate for intended use |
| Lateral pull-to-failure | Adequate for intended use |
| Offset load-to-failure | Adequate for intended use |
| Insertion torque-to-failure | Adequate for intended use |
| Fatigue with pull-to-failure | Adequate for intended use |
| Fretting | Adequate for intended use |
| Pitting corrosion | Adequate for intended use |
| Magnetic resonance (MR compatibility) | Adequate for intended use |
| Cytotoxicity | Adequate for intended use |
| Pyrogenicity | Adequate for intended use |
| Endotoxin testing | Met recommended limit of |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.