LogoFDA 510(k) Search
K Number
K050606
Device Name
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
Manufacturer
SYNTHES (USA)
Date Cleared
2005-04-06

(27 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes 1.0mm Ti. Cortex, Self-drilling Screws are intended for use as follows:

Specific Indications:

  • Nasoethmoidal fractures .
  • Infraorbital area fractures .
  • Frontal sinus wall fractures .
  • Infant craniofacial surgery .

General Indications:

  • Maxillofacial surgery .
Device Description

The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 - 4 mm.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary and FDA clearance letter for a medical device (Synthes 1.0mm Ti. Cortex, Self-drilling Screws), focusing on its substantial equivalence to predicate devices and its intended use. It does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about sample sizes for test sets, data provenance, or training sets.
  • Information on expert ground truth establishment, adjudication methods, or MRMC studies.
  • Mention of standalone algorithm performance or the type of ground truth used for performance evaluation.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.