(87 days)
No
The 510(k) summary describes a system of self-drilling screws for craniofacial fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The description focuses on the physical characteristics and intended use of the screws.
No
The device is described as self-drilling screws for internal fixation in the craniofacial skeleton, which is a tool used during surgery rather than a therapeutic device that treats or cures a disease or medical condition.
No
Explanation: The device, the MODUS System Self-drilling Screws, is described as hardware for internal fixation in the craniofacial skeleton. Its intended use is for "positional and functional stability" following trauma, reconstruction, or surgical correction. This indicates it is a therapeutic or structural device, not one designed to identify, monitor, or detect medical conditions or diseases.
No
The device description clearly states it is a physical screw made of titanium, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- MODUS System Self-drilling Screws: This device is a surgical implant used for internal fixation within the craniofacial skeleton. It is a physical device implanted inside the body to provide structural support.
The intended use and device description clearly indicate that this is a surgical implant for internal fixation, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The MODUS System is intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations. The MODUS System Self-drilling Screws are intended for use in the internal fixation in The MODUS System bell driming becoming became which require positional and functional stability.
Product codes
HWC
Device Description
The MODUS® System Self-drilling Screws are self-tapping self drilling screws for use with the cleared MODUS plates and mesh fixation components. The screws are made from CP titanium, Grade 4 or titanium alloy. The screws are available in lengths ranging from 3 mm to 8 mm and diameters ranging from 1.2 to 2.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton
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)
The MODUS Self-drilling Screws have the same intended use as the predicate devices. Like these predicate devices, the Straumann MODUS Self-drilling Screws are intended to be used for the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dentofacial deformations.
As are the predicate devices, the MODUS Self-drilling Screws are composed of commercially pure Grade 4 titanium or titanium alloy. In addition, the design of the MODUS Self-drilling Screws is the same as the Synthes Self-Drilling screws, the KLS Martin Drill-Free Screws, the Lorenz Self-Drilling Screw, and the Leibinger Self-Drilling Screw. Like these predicate devices, the MODUS Selfdrilling Screws have a tapered thread for self drilling capability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K946165, K983485, K971297, K970912, K974107
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SEP 1 7 1999
ATTACHMENT 8 - 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 Contact Person: Linda Jalbert, Director of Regulatory Affairs
2. Name of the Device
| Trade Name: | MODUS® System Self-drilling Screws |
|---|---|
| Common Name: | Craniomaxillofacial Fixation Plates/ Screws |
| Classification Name: | Multiple component bone fixation metallic |
| appliances (21 CFR 888.3030) |
Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
MODUS System Screws (K946165) Synthes Self-Drilling Maxillofacial Screw (K983485) KLS Martin Drill-Free Screws (K971297) Lorenz Self-Drilling Screw Leibinger Self-Drilling Screw (K970912) TIMESH System Screws (K974107)
4. Description of the Device
The MODUS® System Self-drilling Screws are self-tapping self drilling screws for use with the cleared MODUS plates and mesh fixation components. The screws are made from CP titanium, Grade 4 or titanium alloy. The screws are available in lengths ranging from 3 mm to 8 mm and diameters ranging from 1.2 to 2.0 mm.
న. Intended Use of the Device
There is no change to the intended use or indications for use of the cleared MODUS system, with the modified Self-drilling screws. The MODUS System is intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations.
6. Basis for Substantial Equivalence
The MODUS Self-drilling Screws are substantially equivalent to the MODUS self tapping screws, Synthes Self-Drilling screws, the KLS Martin Drill-Free Screws, the Lorenz Self-Drilling Screw, the Leibinger Self-Drilling Screw, and the TIMESH System Screws in intended use, material and design.
1
The MODUS Self-drilling Screws have the same intended use as the predicate devices. Like these predicate devices, the Straumann MODUS Self-drilling Screws are intended to be used for the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dentofacial deformations.
As are the predicate devices, the MODUS Self-drilling Screws are composed of commercially pure Grade 4 titanium or titanium alloy. In addition, the design of the MODUS Self-drilling Screws is the same as the Synthes Self-Drilling screws, the KLS Martin Drill-Free Screws, the Lorenz Self-Drilling Screw, and the Leibinger Self-Drilling Screw. Like these predicate devices, the MODUS Selfdrilling Screws have a tapered thread for self drilling capability.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
SEP 1 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Jalbert Director. Regulatory Affairs Straumann USA for Medartis AG · Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K992106 MODUS Self-Drilling Screws Regulatory Class: II Product Code: HWC Dated: June 18, 1999 Received: June 22, 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 the Federal Register. Please note: this response to your 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.
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Page 2, -Ms. Linda Jalbert
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) 594-4659. 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 premarket notification" (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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN): K 9 9 2 10
MODUS® System Self-drilling Screws DEVICE NAME:
INDICATIONS FOR USE:
The MODUS System Self-drilling Screws are intended for use in the internal fixation in The MODUS System bell driming becoming became which require positional and functional stability.
(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) | X |
|---|---|
| OR | |
| Over-The-Counter-Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K942106 |
|---|---|
| --------------- | --------- |