MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

K043297 · Medicon EG · JEY · Feb 23, 2005 · Dental

Device Facts

• Record ID: K043297
• Device Name: MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
• Applicant: Medicon EG
• Product Code: JEY · Dental
• Decision Date: Feb 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.

Device Story

Mandibular reconstruction plating system; includes titanium plates (2.5mm thick), titanium alloy Star*Grip screws, and surgical instruments. Plates feature locking holes and various configurations (straight, angled, preformed). Screws are self-tapping, 2.4mm (locking/non-locking) or 2.7mm (non-locking/emergency). Used by surgeons in clinical settings for bone fixation and defect bridging. Device supplied non-sterile; requires moist heat sterilization before use. System provides mechanical stabilization of mandibular bone segments to facilitate healing and structural restoration.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Titanium plates, titanium alloy screws. Dimensions: 2.5mm plate thickness. Features: Locking and non-locking screw holes, self-tapping screws. Sterilization: Moist heat. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring mandibular bone replacement, bridging of mandibular defects (primary or secondary), fixation of mandibular bone stumps, or fixation of bone grafts in emergency or non-emergency settings.

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

• Medicon Titanium Mandibular Reconstruction System (K951689)

Submission Summary (Full Text)

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Kou3297

# FEB 2 3 2005

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

### 1. General Information

| Proprietary Name: | Medicon 2.4 Mandibular Reconstruction<br>Plating System |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Mandibular Fixation System |
| Classification Name: | Bone Plate |
| Classification Code(s): | JEY, 872.4760 |
| Submitter: | Medicon, E.G.<br>Gaensaecker 15<br>Tuttlingen, D-78532<br>Germany<br>Tel.: [phone]<br>Fax: [phone]-9931 |
| Est. Reg. No. | 8010099 |
| Contact Person: | Angelika Scherp<br>Requlatory Affairs<br>Tel.: [phone] |
| Summary Preparation Date: | November 22, 2004 |

#### 2. Device Description

The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws.

The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended.

Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, depth gauge, cheek retractor with drill guide

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and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.

#### 3. Intended Use

The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.

#### 4. Substantial Equivalence

The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the previously cleared Medicon Titanium Mandibular Reconstruction System (K951689), with the following modifications:

- a) Plates
- · Change in material from titanium alloy to titanium
- · Thickness increased from 2 mm to 2.5 mm
- · Thread added to holes
- · Product line expanded to include anatomically preformed plates
- b) Screws
- · Product line expanded to include 2.4-mm-diameter screws with and without locking function
- c) Instruments
- · Product line expanded to include cutting lever, plate cutting forceps and tap.

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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 features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

FEB 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicon, E.G. C/O Ms. Angelika Scherp Director, Regulatory Affairs Business Support International Amstel 320-I Amsterdam, 1017AP NETHERLANDS

Re: K043297

Trade/Device Name: Medicon 2.4 Mandibular Reconstruction Plating System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 4, 2005 Received: January 31, 2005

Dear Ms. Scherp:

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. Scherp

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,

Chin Lin, 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): _K043297

## Device Name: Medicon 2.4 Mandibular Reconstruction Plating System

Indications for Use:

The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.

× Over-The-Counter Use Prescription Use Prescription 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)

Page 1 of 1

Susan Rundor

Sign-Off

s.on of Anesthesiology, General Hospital, action Control. Dental Devices

Number K093297