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K Number
K234128
Device Name
Phantom Fibula Nail System
Manufacturer
Paragon 28, Inc.
Date Cleared
2024-08-22

(238 days)

Product Code
HSB
Regulation Number
888.3020
Type
Traditional
Panel
OR
Reference & Predicate Devices
K143276,K163014,K173656
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.

Device Description

The Phantom Fibula Nail System consists of nails, screws, and accessories for the intended use of fibula repair. The implants are provided in multiple sizes and lengths.

AI/ML Overview

This FDA 510(k) summary does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device, as the Phantom Fibula Nail System is a physical medical device (intramedullary fixation rod) and not an AI/ML product.

Therefore, the requested information components (1 through 9) related to AI/ML device performance, ground truth, and study design are not applicable to this document. The document describes the substantial equivalence of the physical device to a predicate device through performance testing of the device components (e.g., ASTM F1264 for nails, ASTM F543 for screws, ASTM F1875 for corrosion).

§ 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.