MODUS 2.5 MANDIBULAR TRAUMA SET

K992683 · Medartis AG · JEY · Nov 24, 1999 · Dental

Device Facts

• Record ID: K992683
• Device Name: MODUS 2.5 MANDIBULAR TRAUMA SET
• Applicant: Medartis AG
• Product Code: JEY · Dental
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.

Device Story

The MODUS® 2.5 Mandibular Trauma Set is a craniofacial fixation system used for the stabilization of mandibular fractures. The system consists of titanium plates, titanium screws, templates, and associated surgical instruments. It is intended for use by surgeons in a clinical or hospital setting to fixate bone segments in cases of trauma, comminuted fractures, or bone loss. The surgeon selects appropriate plates and screws to provide mechanical stability to the fractured mandible, facilitating bone healing. The device is purely mechanical and does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium plates and screws; mechanical bone fixation system; non-powered; manual surgical instrumentation.

Indications for Use

Indicated for patients with mandibular trauma fractures, including unstable or comminuted fractures and bone loss.

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

• MODUS Titanium Osteosynthesis System (K946165)
• KLS Martin 2.5 Mandibular Fracture Set (K950045)
• W. Lorenz 2.4 Fracture System
• Synthes 2.4 Mandibular Fracture Set (K961421)
• Leibinger CMF Modular Plating System

Submission Summary (Full Text)

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NOV 2 4 1999

# ATTACHMENT 7 - 510(k) Summary

### 1. Applicant's Name and Address

Straumann USA (on behalf of Medartis, GmbH) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 Fax Number: 781-890-6464 Linda Jalbert, Director of Regulatory Affairs Contact Person:

## 2. Name of the Device

| Trade Name: | MODUS® 2.5 Mandibular Trauma Set |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Craniofacial fixation system |
| Classification Name: | Multiple component bone fixation metallic<br>appliances<br>(21 CFR 888.3030) |

#### 3. Claimed Legally Marketed Devices to which Equivalence is (Predicate Devices)

- KLS Martin 2.5 Mandibular Fracture Set (K950045) .
- W. Lorenz 2.4 Fracture System .
- Synthes 2.4 Mandibular Fracture Set (K961421) .
- Leibinger CMF Modular Plating System .

## 4. Description of the Device

The MODUS® 2.5 Mandibular Trauma Set is a complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories.

## ട. Intended Use of the Device

The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.

## 6. Basis for Substantial Equivalence

The MODUS® 2.5 Trauma Set is substantially equivalent in intended use, design, and materials to the MODUS® Titanium Osteosynthesis System previously cleared in K946165, the KLS Martin 2.5 Mandibular Fracture Set, the W. Lorenz 2.4 Fracture System, the Synthes 2.4 Mandibular Fracture Set, and the Leibinger CMF Modular Plating System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

Medartis c/o Ms. Linda Jalbert Medartis Director, Regulatory Affairs Straumann USA 1601 Trapelo Road Reservoir Place Waltham, MA 02451

Re: K992683 Trade Name: MODUS 2.5 Mandibular Trauma Set Regulatory Class: II Product Code: JFY November 9, 1999 Dated: Received: November 10, 1999

Dear Ms. Jalbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Jalbert

Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ens regaration costion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdaj.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

hy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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19921085 510(k) NUMBER (IF KNOWN) :

MODUS® 2.5 Mandibular Trauma Set DEVICE NAME:

INDICATIONS FOR USE:

The MODUS® 2.5 Trauma Set is intended for use in mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Rumpf

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number -