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K Number
K031989
Device Name
ORTRAUTEK ORTHOGNATHIC SYSTEM
Manufacturer
TEKKA
Date Cleared
2003-10-28

(123 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K854886,K974555,K021618,K944561,K944565,K953385,K012910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

Device Description

The ORTRAUTEK ORTHOGNATHIC SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloyed titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm, 0.6 mm, or 0.8 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5MM.

AI/ML Overview

I am sorry, but based on the limited information provided in the given text, I cannot describe the acceptance criteria and the study that proves the device meets them. The text primarily focuses on the 510(k) summary for the "ORTRAUTEK ORTHOGNATHIC SYSTEM," detailing its description, predicate devices, and intended use as part of its substantial equivalence claim to previously marketed devices.

There is no mention of:

  • Acceptance criteria: Specific performance metrics or thresholds the device needs to meet.
  • A study proving acceptance criteria: Details about any clinical or performance studies, their design, results, or statistical analyses.
  • Sample sizes: For test sets or training sets.
  • Data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a premarket notification (510(k)) that argues for substantial equivalence primarily based on material, design, composition, function, and intended use being identical or similar to predicate devices. It does not contain the kind of detailed performance study information typically found when a device is evaluated against specific acceptance criteria.

§ 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.