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.

Device Description

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.

AI/ML Overview

This document is regarding a 510(k) premarket notification for a medical device called MODUS® Trilock® 2.0/2.3/2.5. It is a bone plate system intended for use in the mandible and mid-face region for various types of fractures and reconstruction.

Based on the provided text, none of the requested information about acceptance criteria, study data, ground truth, or expert involvement is present.

This 510(k) summary focuses on establishing substantial equivalence to previously cleared predicate devices, detailing:

Administrative information (manufacturer, contact, etc.)
Device name, classification, and intended use
Device description
Comparison to predicate devices to demonstrate substantial equivalence in terms of intended use, operating principle, basic design, materials, and sterilization.
The FDA's decision letter acknowledging the substantial equivalence and permitting marketing.

The document does not contain information typically found in a clinical or performance study report, such as:

Acceptance criteria and reported device performance: No specific performance metrics (e.g., strength, durability, biocompatibility test results) or the criteria these results needed to meet are mentioned.
Sample size and data provenance: No test samples (e.g., patient cases, specific materials tested) are detailed for any study.
Number of experts and qualifications: No experts are mentioned as having established ground truth or reviewed data.
Adjudication method: Not applicable as no expert review process is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is a physical implant device, not an AI or imaging diagnostic tool that would typically involve human readers.
Standalone performance: Not applicable for a physical implant device in the same way it would be for an algorithm.
Type of ground truth: No ground truth is mentioned.
Training set sample size: Not applicable as this is not a machine learning device.
Ground truth for training set: Not applicable.

The FDA's 510(k) process for this type of device (bone plates) primarily relies on demonstrating substantial equivalence to already legally marketed devices, often through non-clinical performance testing (e.g., mechanical testing, biocompatibility) rather than extensive clinical studies with human subjects or AI performance evaluations, which are not outlined in this summary.

Summary

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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 +41 61 228 18 18 Fax +41 61 228 18 00

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 1 (858) 792-1235 Fax 1 (858) 792-1236 email: Ischulz@paxmed.com or flarson@paxmed.com

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

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DEVICE DESCRIPTION

2072
K071612

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.