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K Number
K161489
Device Name
Syntorr K-wire and Pin System
Manufacturer
SYNTORR INC
Date Cleared
2016-09-16

(107 days)

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

The Syntorr K-wire and Pin System is indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the "Syntorr K-wire And Pin System." It is a regulatory clearance letter, not a study report or technical specification outlining acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert adjudication, MRMC study, standalone performance, ground truth, training set size), and how ground truth was established is not available in the provided text.

The document primarily focuses on:

  • Device Name: Syntorr K-wire and Pin System
  • Regulation Number & Name: 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
  • Regulatory Class: Class II
  • Product Code: HTY, JDW
  • Indications for Use: Open and percutaneous fixation of bone fractures, bone reconstructions, guide pins for insertion of other implantation through the skin, and traction pins.
  • Regulatory Clearance: Substantial equivalence determination to predicate devices.

§ 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.