MODUS IMF SCREWS 2.0

K052061 · Medartis, Inc. · DZE · Oct 21, 2005 · Dental

Device Facts

• Record ID: K052061
• Device Name: MODUS IMF SCREWS 2.0
• Applicant: Medartis, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

Device Story

MODUS IMF Screws 2.0 are self-drilling, endosseous screws used for temporary intermaxillary fixation. Device features cross heads with holes for wire insertion and grooves for elastic band attachment. Available in two plateau geometries and various lengths. Used by clinicians in orthognathic or orthodontic procedures to stabilize bone fragments or restore occlusion. Operates as a mechanical fixation aid; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-drilling endosseous screws; cross head design with wire holes and elastic grooves; two plateau geometries; various lengths; mechanical fixation; non-electronic.

Indications for Use

Indicated for temporary reduction and fixation of dislocated or fractured bone fragments, condylar fractures, and restoration of occlusion in orthognathic or orthodontic procedures.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Submission Summary (Full Text)

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K052061

# 3CT 2 1 2005

# 510(k) Summary Medartis, Inc. MODUS® IMF Screws 2.0

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis, Inc. 127 W Street Road, Suite 203 Kennett Square, PA 19348

Telephone [phone] FAX [phone]

Kate Gehret

Official Contact:

Representative/Consultant:

Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200

San Diego, CA 92130 Telephone [phone] FAX [phone]

## DEVICE NAME

| Classification Name: | Implant, Endosseous, Root Form |
|-------------------------|--------------------------------|
| Trade/Proprietary Name: | MODUS® IMF Screws 2.0 |
| Common Name: | Intermaxillary fixation screw |

## ESTABLISHMENT REGISTRATION NUMBER

Medartis, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number has not yet been assigned. The owner/operator number for Medartis AG, the parent company of Medartis, Inc., is 9033581.

## DEVICE CLASSIFICATION

FDA has classified root form endosseous implants as Class II Special Controls (21 CFR 872.3640). The product code is DZE. This device classification is reviewed by the Dental Devices Branch.

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#### INTENDED USE

MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

#### DEVICE DESCRIPTION

The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.

#### EQUIVALENCE TO MARKETED PRODUCT

For the purposes of FDA's regulation of medical devices, the MODUS IMF Screws 2.0 are substantially equivalent in indications and design principles to the predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle. The eagle is composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services.

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medartis, Incorporated C/O Mr. Floyd G. Larson President Paxmed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K052061

Trade/Device Name: MODUS IMF SCREWS 2.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: July 28, 2005 Received: August 3, 2005

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases resident is substantially equivalent (for the felerenced above and have determined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseee pror to that have been reclassified in accordance with the provisions of Annuments, or to de rises that in the Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval application (1 Mill). The general controls provisions of the Act include condivis provisions of the rist stim tion, listing 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 II your device is classince (oss as 10) and controls. Existing major regulations affecting (FMA), it may of subject to Satin adam Sales of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Sous 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 mean that FDA has made a determination that your device complies with other requirements modi that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal banks as a requirements, including, but not limited to: registration 1 ou intilet compry while was 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); appreadies the elections fletter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence m your bection 510(t) premaries ed 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 at 110 at 110 mpliance at [phone]. 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 of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Switte y. Michael Davis

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):

Device Name: MODUS® IMF Screws 2.0

Indications for Use:

MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

Over-The-Counter Use Prescription Use _X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Susan Runner

vision Sign-Off) Vision Sign-Oh)
vision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: