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K Number
K220723
Device Name
Hand Trauma Screw System
Manufacturer
Skeletal Dynamics, Inc.
Date Cleared
2022-05-12

(59 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K201662,K133842
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hand Trauma Screw System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.

Device Description

The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation.

  • 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments. ●
  • 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
  • 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
  • 4.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
    The system is provided non-sterile and is sterilized in the user facility.
AI/ML Overview

This FDA 510(k) clearance document for the "Hand Trauma Screw System" does not describe an AI/ML device. It pertains to a physical medical device (bone screws) and therefore the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document.

The document discusses substantial equivalence based on:

  • Engineering analysis
  • Mechanical testing (ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws)

It concludes that the device is substantially equivalent to predicate devices based on similarities in intended use, indications for use, materials, design, performance, sterility, and packaging. There is no mention of an algorithm, AI, or specific performance metrics related to diagnostic or predictive capabilities.

§ 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.