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K Number
K050819
Device Name
CHARLOTTE SNAP-OFF SCREW
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2005-04-11

(11 days)

Product Code
HWC
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
K043583
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

  • · Fixation of Small Bone Fragments
  • · Weil osteotomy
  • · Mono-cortical fixation
  • · Osteotomies and fractures fixation in the foot and hand
Device Description

The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
Screw

  • Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
  • Available in one diameter and three lengths .
  • Self drilling and self tapping features on distal threads .
AI/ML Overview

The provided text describes the CHARLOTTE™ Snap-Off Screw and states that its substantial equivalence was confirmed by testing conforming to ASTM F543-02. However, the document does not explicitly state acceptance criteria or provide a detailed study report with device performance metrics against specific criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance from the provided text. Additionally, the document does not contain information on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

Based on the provided text, none of the specific details required for your request are available.

The document primarily focuses on:

  • The intended use and device description of the CHARLOTTE™ Snap-Off Screw.
  • Stating its substantial equivalence to a previously cleared device (K043583).
  • Mentioning conformance to ASTM F543-02 as the basis for confirming substantial equivalence, which is a standard for metallic medical bone screws.
  • The FDA's 510(k) clearance letter.

To fully answer your request, a detailed study report or the specific performance data against ASTM F543-02 would be needed.

§ 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.