MODUS TRILOCK 2.0/2.3/2.5

K071612 · Medartis AG · JEY · Sep 11, 2007 · Dental

Device Facts

• Record ID: K071612
• Device Name: MODUS TRILOCK 2.0/2.3/2.5
• Applicant: Medartis AG
• Product Code: JEY · Dental
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures, symphysis fractures, fractures of the atrophic mandible and fractures of the orbit and zygoma complex. Marodibular reconstruction may be performed with free or vascular bone graft.

Device Story

Fixation system for mandibular and mid-face trauma/reconstruction; consists of implant plates and TriLock HexaDrive® 6 locking screws. Used by surgeons in clinical settings to stabilize bone segments. Plates feature modified screw holes to accommodate locking screws, providing rigid fixation. System sold non-sterile; requires sterilization before use. Output is mechanical stabilization of bone fractures or reconstruction sites, facilitating healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Bone fixation system comprising titanium alloy plates and screws. Features TriLock HexaDrive® 6 locking mechanism. Non-sterile; requires steam sterilization. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring fixation in the mandible and mid-face region for osteotomies, severe/comminuted fractures (condylar neck, mandibular angle, symphysis, atrophic mandible, orbit, zygoma complex), and mandibular reconstruction with bone grafts.

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 2.5 Mandibular Resonstruction Set (K992682)
• Modus Titanium Osteosynthesis System (K050934)
• KLS Martin Mandibular/Reconstruction System II (K032442)
• Synthes 2.0 mm Locking Plate System (K974555)
• Synthes 2.4 Universal Locking Plate System (K961421)
• Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594)
• OsteoMed 2.0 Locking Plate System (K030448)

Submission Summary (Full Text)

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510(k) Summary

K071612

MODUS® Trilock® 2.0/2.3/2.5 100 2

# 510(k) Summary

## Medartis AG MODUS® Trilock® 2.0/2.3/2.5

### SEP 1 1 2007

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis AG Austrasse 24 Basel, CH 4051 Switzerland Telephone [phone] Fax [phone]

Official Contact:

Kerttu Spiess

Representative/Consultant:

Linda Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone] email: [e-mail] or [e-mail]

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | MODUS® Trilock® 2.0/2.3/2.5 |
|-----------------------------|-----------------------------|
| Common Name: | Bone plate |
| Classification Regulations: | 21 CFR 872.4760, Class II |
| Product Codes | JEY |

### DEVICE CLASSIFICATION PANEL

The Classification Panel for these devices is the Dental Products Panel, and they are reviewed by the Dental Devices Branch

#### INTENDED USE

The MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures of the atrophic mandible and fractures of the orbita and zygoma complex. Mandibular reconstruction may be performed with free or vascular bone graft.

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### DEVICE DESCRIPTION

2072
K071612

MODUS® TriLock® 2.0/2.3/2.5 is a fixation system for use in mandibular and midface trauma and reconstruction. It consists of implant plates and implant screws. Manual surgical instruments, Class I exempt and not a subject of this submission, are included in the system.

The plates of the subject system are the same as plates included in the previously cleared predicate Modus Titanium Osteosynthesis System (K050934), except that the screw holes of the subject system plates are designed to accommodate TriLock Hexadrive® 6 locking screws.

The MODUS® TriLock® 2.0/2.3/2.5 will be packaged and sold non-sterile and must be sterilized prior to use. The device is not represented to be "pyrogen free." Medartis recommends sterilization in the specially designed sterilization containers, instrument trays and implant containers.

### EQUIVALENCE TO MARKETED PRODUCT

The basis for Medartis AG's belief that the MODUS® TriLock® 2.0/2.3/2.5 System is substantially equivalent to the following predicate devices. Modus 2.5 Mandibular Resonstruction Set cleared under K992682, Modus Titanium Osteosynthesis System cleared under K050934, KLS Martin Mandibular/Reconstruction System II cleared under K032442, Synthes 2.0 mm Locking Plate System cleared under K974555, Synthes 2.4 Universal Locking Plate System cleared under K961421, Stryker Leibinger Locking Screw Mandibular Reconstruction Plate cleared under K000594 and OsteoMed 2.0 Locking Plate System cleared under K030448.

The plates of the subject system are the same as plates included in the predicate Modus Titanium Osteosynthesis System, except that the screw holes of the subject system plates are designed to accommodate TriLock HexaDrive® 6 locking screws.

MODUS® TriLock® 2.0/2.3/2.5 has the following similarities to the predicate devices:

- · has the same intended use.
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · has similar packaging and is sterilized using the same materials and processes.

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the MODUS® Trilock® 2.0/2.3/2.5 is substantially equivalent in indications and design principles to 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medartis AG C/O Ms. Linda Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

SEP 1 1 2007

Re: K071612

Trade/Device Name: MODUS® Trilock® 2.0/2.3/2.5 Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 4, 2007 Received: September 5, 2007

Dear Ms. Schulz:

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. Schulz

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 vours.

Cluts

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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510(k) Premarket Notification

MODUS® Trilock® 2.0/2.3/2.5

K07/6/2
Indications for Use

/06/

### Indications for Use

510(k) Number (if known):

Device Name:

MODUS® Trilock® 2.0/2.3/2.5

Indications for Use:

The MODUS® TriLock® 2.0/2.3/2.5 is intended for use in the mandible and mid-face region for osteotomies, severe fractures and comminuted fractures. These fractures may include condylar neck fractures, mandibular angle fractures, symphysis fractures, fractures of the atrophic mandible and fractures of the orbit and zygoma complex. Marodibular reconstruction may be performed with free or vascular bone graft.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stever Fraser
(Division Sign-Off)

Page 1 of

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO7162 510(k) Number: