(62 days)
The SBi rHead Plating System is indicated for fractures of the proximal radius.
The SBi rHead Plating System consists of various plates and screws to treat fractures of the proximal radius. SBi plans to offer two plate designs: the rHead Neck Plate and the rHead Rim Plate. Both have a curved, T-shaped design to match the geometry of the proximal radius. Both will be available in a variety of neck widths, plate lengths, and hole geometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHead Plating System.
The provided document is a 510(k) summary for a medical device (SBi rHead Plating System). It is a regulatory submission for market clearance and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on:
- Device Description: The SBi rHead Plating System consists of plates and screws for proximal radius fractures.
- Intended Use: Fractures of the proximal radius.
- Material: Stainless steel.
- Substantial Equivalence: The manufacturer claims the device is substantially equivalent to other legally marketed devices, which is the basis for 510(k) clearance.
Therefore, I cannot provide the requested information from the given text as it is not present in the document. This type of submission relies on demonstrating similarity to existing devices, rather than presenting clinical or performance data against specific acceptance criteria.
§ 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.