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K Number
K113567
Device Name
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
Manufacturer
SYNTHES INC
Date Cleared
2012-11-19

(353 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K063790,K974555
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:

  • . Trauma
  • . Reconstructive surgery
  • . Orthognathic surgery (surgical correction of dentofacial deformities)
Device Description

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.

This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use).

MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (MatrixMANDIBLE Plate and Screw System) and does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.

Instead, this document describes a conventional medical device (bone plates and screws) and seeks to demonstrate substantial equivalence to previously cleared predicate devices based on:

  • Identical/similar Indications for Use.
  • Technological Similarities (principles of operation, configurations, material, screw compatibility).
  • Technological Differences (slight width difference, absence of a straight configuration, one more hole in single angle configurations compared to one predicate).
  • Non-Clinical Performance Data: An engineering assessment including cross-section analysis and finite element analysis was used to compare mechanical properties to predicate devices. This assessment determined the mechanical properties were comparable.
  • No Clinical Performance Data: The document explicitly states, "No clinical testing was performed to support this submission."

Therefore, it is not possible to fill out the requested table and information as it pertains to an AI/ML device, as the provided input describes a different type of medical device submission.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.