OSTEOMED MODULAR LOCKING FIXATION SYSTEM

K080694 · Osteomed LP · JEY · May 15, 2008 · Dental

Device Facts

• Record ID: K080694
• Device Name: OSTEOMED MODULAR LOCKING FIXATION SYSTEM
• Applicant: Osteomed LP
• Product Code: JEY · Dental
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

Device Story

System consists of titanium alloy plates, screws, and surgical instrumentation for cranio-maxillofacial, mandibular, and orthognathic fracture fixation. Locking screw and plate interface allows up to 20 degrees of angulation. Surgeon selects from locking standard, locking Auto-Drive, standard nonlocking, safety, or Auto-Drive screws based on clinical need. Instrumentation includes drill bits, plate bending pliers, forceps, cutters, guides, cannulae, taps, countersinks, and screwdrivers. Used by surgeons in clinical settings to stabilize bone segments; facilitates reconstruction and healing of trauma or orthognathic defects.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and operational similarities to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium Alloy (ASTM F-136) and commercially pure Titanium (ASTM F-67). System includes plates, screws, and manual instrumentation (drills, pliers, forceps, cutters, guides, cannulae, taps, countersinks, screwdrivers). Locking interface allows 20-degree angulation. Single-use implants and drills.

Indications for Use

Indicated for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction. Intended for single use only.

Regulatory Classification

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.

Predicate Devices

• Synthes (K063790)
• Stryker (K022185)
• KLS (K032442)
• OsteoMed (K911936)
• OsteoMed (K924138)
• OsteoMed (K030448)
• Lorenz (K063052)

Submission Summary (Full Text)

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K080694

## 510(k) Summary

Device Proprietary Name:

OsteoMed Modular Locking FixationAY 1 5 2008
Suntam System

Device Common Name:

Classification Name:

Name of Submitter:

System

Modular Locking Fixation System

JEY, Bone Plate

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

Contact Person:

Piedad Peña

Date Prepared:

March 10, 2008

Summary:

This submission describes the OsteoMed Modular Locking Fixation System indicated for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The implants and drills are intended for single use only.

The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790. Stryker K022185. KLS K032442. OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052).

OsteoMed also notes, that some sections of this system could have been letter to file based on the OsteoMed previously cleared submissions. The intent of this submission is to present the system as complete modules and include the

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changes to the designs, which would allow up to 20 degrees of angulation within the locking screw and plate interface.

The locking screw and plate interface designs and operational principles addressed in this submission are based on similarities to the predicate devices Synthes (K063790), Stryker (K022185), and KLS (K032442) based on their promotional materials and labeling.

Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2008

Ms. Piedad Peña Regulatory Affairs Specialist OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K080694

Trade/Device Name: OsteoMed Modular Locking Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 10, 2008 Received: March 11, 2008

Dear Ms. Peña:

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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## Page 2 - Ms. Peña

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 (QS) 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/industry/support/index.html.

Sincerely yours.

Clars

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: OsteoMed Modular Locking Fixation System Indications for Use:

The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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(Posted November 13, 2003) 510(k) Number:

10850694