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K Number
K032520
Device Name
ORTRAUTEK TRAUMA SYSTEM
Manufacturer
TEKKA
Date Cleared
2003-11-12

(89 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
K854886,K022185,K002619,K974555,K944561,K953385
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.

Device Description

The ORTRAUTEK TRAUMA 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 unalloved 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 or 0.6 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5 mm.

AI/ML Overview

The provided document is a 510(k) summary for the ORTRAUTEK TRAUMA SYSTEM. This type of regulatory submission establishes substantial equivalence to predicate devices and does not typically include detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the way that an AI/ML medical device submission would.

Therefore, the document does not contain the information required to populate the acceptance criteria and study details for an AI-based device.

The document discusses:

  • Device Trade Name: ORTRAUTEK TRAUMA SYSTEM
  • Common/Usual Name: Bone Plate System
  • Classification Name: Bone Plate
  • Predicate Devices: Several bone plate systems (K854886, K022185, K002619, K974555, K944561, K953385).
  • Device Description: Composed of bone plates and bone screws made of unalloyed titanium (meeting ASTM F67 and F136 standards, respectively), and associated accessories.
  • Intended Use: Cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization, and rigid fixation of cranio-maxillofacial fracture and reconstruction.
  • Basis of Substantial Equivalence: Identical in material, design, composition, function, and intended use to predicate devices.

There is no mention of acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth, expert adjudication, or AI/ML-related studies within this document. This is a hardware device (bone plates and screws), not a software or AI-driven diagnostic/therapeutic device that would rely on such performance metrics.

§ 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.