(90 days)
None
No
The description focuses on the mechanical components (plates and screws) of a fixation system and does not mention any software, algorithms, or data processing related to AI/ML.
Yes.
The device is a fixation system consisting of implant plates and screws used for mandibular and mid-face trauma and reconstruction, which directly addresses medical conditions.
No
The device is a fixation system used for treating osteotomies and fractures in the mandible and mid-face region, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of "implant plates and implant screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The MODUS® TriLock® 2.0/2.3/2.5 is a system of implant plates and screws used for surgical fixation of bones in the mandible and mid-face. It is a physical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use clearly describes surgical procedures for fixing fractures and performing reconstructions, which are clinical interventions, not diagnostic tests.
Therefore, based on the provided information, the MODUS® TriLock® 2.0/2.3/2.5 is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MODUS® TriLock® 2.0/2.5 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.
Product codes
JEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible and mid-face region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992682, K050934, K032442, K974555, K961421, K000594, K030448
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
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
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.
1
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.
2
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.
3
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
4
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: