The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

Device Description

The MODUS® Titanium Osteosynthesis System consists of implant plates, implant screws and instruments and is used for the internal fixation of fractures, correction osteotomies, the bridging of load bearing bone segments and distraction in the craniofacial skeleton. This submission includes modifications to the MODUS system plates that enhance clinical effectiveness due to improved strength or anatomical adaptation. All modifications discussed in this submission use previously cleared Medartis titanium screws.

AI/ML Overview

The provided text is a 510(k) summary for a medical device modification. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study proving the device meets them, including:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
MRMC comparative effectiveness study details
Standalone performance study
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The available text focuses on:

Device Name: MODUS® Titanium Osteosynthesis System
Manufacturer: Medartis, Inc.
Predicate Device: MODUS® Titanium Osteosynthesis System from Medartis AG (originally Elekta Instruments, Inc. CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation System, K946165; and MODUS® 2.5 Mandibular Trauma Set, K992683).
Device Classification: Class II (21 CFR 872.4760), Product Code JEY.
Intended Use: For osteotomies and fractures involving any part of the craniofacial skeleton requiring positional and functional stability. Specific indications listed include fixation in various craniofacial areas, fixation of comminuted fractures, tumor surgery defect bridging, reconstruction of bony structures with mesh, burr hole coverings, nasal bone trauma, dentofacial deformation correction, and post-tumor surgery reconstruction.
Device Description: The system includes implant plates, implant screws, and instruments for internal fixation. The current submission is for modifications to system plates to enhance strength or anatomical adaptation, using previously cleared Medartis titanium screws. The materials (CP titanium) meet ASTM F 67 and ISO 5832-2 standards.
Equivalence to Marketed Product: The modified implants are considered substantially equivalent to the predicate devices due to having the same intended use, operating principle, basic design, and materials.

No performance study details or acceptance criteria are presented in this 510(k) summary.

Summary

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K050934

510(k) Summary - Modifications to the MODUS® Titanium Osteosynthesis System - Page 1

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Medartis, Inc.127 W Street Road, Suite 203Kennett Square, PA 19348Telephone (610) 961-6101FAX (610) 961-6108
Official Contact:	Kate Gehret
Representative/Consultant:	Floyd G. LarsonPaxMed International4329 Graydon RoadSan Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236
DEVICE NAME

Plate, Bone Classification Name: MODUS® Titanium Osteosynthesis System Trade/Proprietary Name: Bone Plates Common Name:

ESTABLISHMENT REGISTRATION NUMBER

Medartis, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number has not yet been assigned.

DEVICE CLASSIFICATION

FDA has classified bone plates as Class II devices (21 CFR 872.4760). The product code for bone plates is JEY. This device classification is reviewed by the Dental Products Panel.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards applicable to bone plates have been established by FDA. However, the CP titanium used to manufacture the MODUS® Titanium Osteosynthesis System meets the chemical and mechanical requirements of ASTM F 67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications and ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium.

PREDICATE DEVICE INFORMATION

The predicate devices for this modification are from the MODUS® Titanium Osteosynthesis System. Medartis AG, the parent organization of Medartis, Inc. has acquired the rights to the Elekta Instruments, Inc. CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation System, cleared by FDA on May 23, 1995 under K946165, and has marketed it as the MODUS® Titanium Osteosynthesis System. The MODUS System was expanded with the addition of the MODUS® 2.5 Mandibular Trauma Set, cleared by FDA

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K050934

510(k) Summary - Modifications to the MODUS® Titanium Osteosynthesis System - Page 2

on November 24, 1999 under K992683. The MODUS System has now been modified by the addition of new shapes, which are the subject of this Special 510(k).

PACKAGING/LABELING/PRODUCT INFORMATION

The MODUS® Titanium Osteosynthesis System will be packaged and sold non-sterile. The device is not represented to be "pyrogen free." All catalogues will be amended to include the modified devices, consistent with the information shown for existing devices.

INTENDED USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

The modified implants included in this submission have the following similarities to the predicate:

· have the same intended use,
· use the same operating principle,
· incorporate the same basic design, and
· incorporate the same materials.

In summary, the modified implants described in this submission are, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human figures connected at the shoulders, with their heads tilted slightly forward. The figures are arranged in a row, with the leftmost figure slightly larger than the others. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the graphic.

MAY - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medartis, Incorporated C/O Mr. Floyd G. Larson President PaxMed, International 11234 El Camino Real San Diego, California 92130

Re: K050934

Trade/Device Name: MODUS® Titanium Ostcosynthesis System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 11, 2005 Received: March 14, 2005

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowed your and have determined the device is substantially equivalent (for the it it it cu above and have accession marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce proc to that have been reclassified in accordance with the provisions of Amendinents, or to do root and Cosmetic Act (Act) that do not require approval of a premarket the reachar Food, Drug, and Ocommay, therefore, market the device, subject to the general approval application (1 million . The general controls provisions of the Act include controls provisions of the Heart of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classinod (see associety). Existing major regulations affecting (FMA), it may oc subject to base of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc tound in the Seas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Larson

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of ally I east a the Act's requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF reful 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quartify sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Prints letter will anon you to FDA finding of substantial equivalence of your device to a premaired predicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific active to: Joiance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn other gater gaternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chun Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 050934

Device Name: MODUS® Titanium Osteosynthesis System

Indications for Use:

The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures The MODOD - Thanham Obtober and requiring positional and functional and functional morenig any part of the erailers in the naso thmoidal, intraorbital, and frontal sinus Subtinty. Incheations interes of maxillo-facial and craniofacial areas; tumor areas, fixation of conminuted fractures on of bony structures by means of mesh materials; Surgely for detect brigging, roomstiations of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) ion Sien-Off, Page 1 of 1 General Hospital, siston or Anuschesiology, Intection Control, Dental De

ge 1 of 1

Number: K050934

Regulation Number and Section

§ 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.