OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM

K051798 · Osteomed LP · DZE · Apr 7, 2006 · Dental

Device Facts

• Record ID: K051798
• Device Name: OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
• Applicant: Osteomed LP
• Product Code: DZE · Dental
• Decision Date: Apr 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.

Device Story

OsteoMed Orthodontic Anchor Plating System consists of metal plates and Auto-Drive screws; surgically implanted in mouth to provide temporary skeletal anchorage for orthodontic procedures; removed after treatment completion. System provides various shapes/sizes to accommodate anatomical requirements; fixed to bone via screws. Used by clinicians in dental/orthodontic settings. Device serves as stable anchor point to facilitate tooth movement; benefits patient by providing reliable anchorage for complex orthodontic corrections.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System includes plates, Auto-Drive screws, and pilot drills. Single-use components. Mechanical fixation to bone. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary orthodontic anchorage. Surgically placed in the mouth to serve as an anchor for orthodontic procedures; removed upon completion of treatment.

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.

Predicate Devices

• KLS-Martin Ortho Anchorage System (K040891)
• Stryker Leibinger Skeletal Anchoring System (K041651)

Submission Summary (Full Text)

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K051798

7 2006 APR

## 510(k) Summary

Device Proprietary Name:

OsteoMed Orthodontic Anchor Plating System

Device Common Name:

Classification Name:

DZE Implant, Endosseous, Root-Form

Name of Submitter:

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Endosseous Implant

Contact Person:

Dawn D. Tindall

Date Prepared:

January 12, 2006

Summary:

This submission describes the OsteoMed Orthodontic Anchor Plating System which includes plates intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. The OsteoMed Orthodontic Anchor Plates are intended for single use only.

The OsteoMed Orthodontic Anchor Plating System plates are provided in various shapes and sizes and are fixed to bone via Auto-Drive screws.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Ortho Anchorage System (K040891) and the Stryker Leibinger Skeletal Anchoring System (K041651).

Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed Orthodontic Anchor Plating System does not raise any new safety or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 2006

Ms. Dawn T. Holderman Regulatory Affairs Osteomed, L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K051798

Trade/Device Name: OsteoMed Orthodontic Anchor Plating System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: January 12, 2006 Received: January 17, 2006

Dear Ms. Holderman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance 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 Division 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/dsma/dsmamain.html

Sincerely yours,

Supt. y. Michael Davis

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): _ Ko Sl 798

OsteoMed Orthodontic Anchor Plating System Device Name:

Indications for Use:

Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)

Sver Rums

" general Hospital Hospita J. Dental Devices

KCS 1798
4000