(106 days)
No
The summary describes a mechanical fracture fixation system with plates, screws, and instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "complete fracture fixation system" used for "mandibular trauma fractures, e.g. in unstable, comminuted mandibular fractures and bone loss," which directly implies a therapeutic function by stabilizing and mending bone fractures.
No
The provided text describes a complete fracture fixation system consisting of plates, screws, and instruments, which are used for treatment (fixation of fractures) rather than for diagnosing a condition.
No
The device description explicitly states it includes titanium plates, screws, templates, instruments, and accessories, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the MODUS® 2.5 Trauma Set is a "complete fracture fixation system that includes titanium plates, titanium screws, templates, and accompanying instruments and accessories" intended for "use in mandibular trauma fractures." This describes a surgical implant and associated tools used directly on the patient's body to fix a physical injury.
- Lack of IVD Characteristics: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
This device falls under the category of a surgical implant/device used for fracture fixation.
N/A
Intended Use / 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.
Product codes
JFY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Image /page/0/Picture/0 description: The image shows a handwritten word that appears to be "KapaloksB". The writing is in cursive and somewhat stylized, making it a bit difficult to read. The letters are connected, and the overall impression is that of a signature or a quick note.
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 |
| appliances | |
| (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.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, with three flowing lines representing hair or a head covering. The face is positioned to the right of the logo. Encircling the face is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
2
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
Page
of
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 -