Search Results

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.

Ask a specific question about this device