(80 days)
The Radial Nail System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray;
- Failed fracture fixation with or without bone graft:
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or fragmentation . of bone;
- Comminuted articular fractures, shearing fractures of the articular surface, severely . comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
The Radial Nail System consists of the following components: Radial Nail, Cortical Bone Screws, Buttress Pins and Screws. The design features of the components included in the Radial Nail System are summarized below:
Radial Nail
- Universal in configuration no lefts or rights
- Available in sizes 1-4
- Color anodized to match instrumentation for easy size identification
2.7 mm Cortical Bone Screws - Lengths available: 12, 14, 16, 18, 20mm
- Color anodized to differentiate from 2.2mm buttress pins and 2.7mm buttress screws
2.2mm Buttress Pins - Lengths available: 20, 22, 24, 26, 28, 30mm
- Color anodized to differentiate from 2.7mm cortical screws and 2.7mm buttress screws
2.7mm Buttress Screws - Lengths available: 20, 22, 24, 26, 28, 30mm
- Color anodized to differentiate from 2.7mm cortical screws and 2.2mm buttress pins
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the "Radial Nail System," which focuses on establishing substantial equivalence to a predicate device.
Specifically, the document contains:
- A 510(k) summary of safety and effectiveness.
- Device description and its components (Radial Nail, Cortical Bone Screws, Buttress Pins, Buttress Screws).
- Intended uses and indications for the Radial Nail System, which are for the fixation of unstable distal radius fractures in various scenarios.
- A statement of substantial equivalence to the LOCON-T® Distal Radial Plating System, noting that the safety and effectiveness are supported by substantial equivalence information, materials information, and analysis data.
- A letter from the FDA indicating that the device has received 510(k) clearance based on substantial equivalence.
There is no mention of:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- A study design (e.g., clinical trial, bench test with performance outcomes) to demonstrate meeting these criteria.
- Sample sizes for test or training sets in the context of performance evaluation.
- Experts establishing ground truth, adjudication methods, or MRMC studies.
- Standalone algorithm performance or types of ground truth used in performance studies.
The clearance is based on substantial equivalence to a previously cleared device, rather than explicit performance criteria demonstrated by a specific study.
§ 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.