LogoFDA 510(k) Search
K Number
K211439
Device Name
Small Bone Nailing System
Manufacturer
Skeletal Dynamics, Inc.
Date Cleared
2021-09-30

(143 days)

Product Code
HTY,HSB
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K033406
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Skeletal Dynamics Small Bone Nailing System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal phalanges.

Device Description

The Skeletal Dynamics Small Bone Nailing System consists of intramedullary nails and screws with diameters of 2.1mm, 3.0mm, and 4.0mm, and lengths from 25mm to 70mm to address proximal phalanx and metacarpal fractures. The intramedullary nails and screws are made of medical grade titanium allov. Cobalt Chrome 1.7mm transfixion screws are also provided in various lengths. Included in the system is specialized instrumentation. The System is provided non-sterile for sterilization in the user facility.

The Small Bone Nailing System is comprised of:

  • Titanium alloy intramedullary nails and screws
  • CoCr locking screws and transfixion screws
  • Stainless steel K-wires (for provisional fixation: not for implantation)
  • System specific instrumentation
AI/ML Overview

This is not an AI/ML device. The document describes a Small Bone Nailing System used for fracture fixation, which is a physical medical device and not a software-based AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from this document.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.