(84 days)
Not Found
Not Found
No
The summary describes a mechanical device (screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a supplementary method for reduction and fixation of bone fragments, not for treating or rehabilitating a disease or injury, which is characteristic of therapeutic devices.
No
The device is described as "temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion", which indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a physical screw with different geometries and lengths, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the reduction and fixation of bone fragments and fractures, and for restoration of occlusion in surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details physical screws designed for surgical implantation and manipulation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fragments
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Page 1 of 2
3CT 2 1 2005
510(k) Summary Medartis, Inc. MODUS® IMF Screws 2.0
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Medartis, Inc. 127 W Street Road, Suite 203 Kennett Square, PA 19348
Telephone (610) 961-6101 FAX (610) 961-6108
Kate Gehret
Official Contact:
Representative/Consultant:
Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200
San Diego, CA 92130 Telephone (858) 792-1235 FAX (858) 792-1236
DEVICE NAME
| Classification Name: | Implant, Endosseous, Root Form |
|---|---|
| Trade/Proprietary Name: | MODUS® IMF Screws 2.0 |
| Common Name: | Intermaxillary fixation screw |
ESTABLISHMENT REGISTRATION NUMBER
Medartis, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number has not yet been assigned. The owner/operator number for Medartis AG, the parent company of Medartis, Inc., is 9033581.
DEVICE CLASSIFICATION
FDA has classified root form endosseous implants as Class II Special Controls (21 CFR 872.3640). The product code is DZE. This device classification is reviewed by the Dental Devices Branch.
1
INTENDED USE
MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.
DEVICE DESCRIPTION
The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.
EQUIVALENCE TO MARKETED PRODUCT
For the purposes of FDA's regulation of medical devices, the MODUS IMF Screws 2.0 are substantially equivalent in indications and design principles to the 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 seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle. The eagle is composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services.
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medartis, Incorporated C/O Mr. Floyd G. Larson President Paxmed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K052061
Trade/Device Name: MODUS IMF SCREWS 2.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: July 28, 2005 Received: August 3, 2005
Dear Mr. Larson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases resident is substantially equivalent (for the felerenced above and have determined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseee pror to that have been reclassified in accordance with the provisions of Annuments, or to de rises that in the Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval application (1 Mill). The general controls provisions of the Act include condivis provisions of the rist stim tion, 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 II your device is classince (oss as 10) and controls. Existing major regulations affecting (FMA), it may of subject to Satin adam Sales of Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the Sous nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Larson
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 modi that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal banks as a requirements, including, but not limited to: registration 1 ou intilet compry while was 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 er read 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); appreadies the elections fletter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence m your bection 510(t) premaries ed 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), If you desire specific at 110 at 110 mpliance 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 may overn 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,
Switte y. Michael Davis
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
Indications for Use
510(k) Number (if known):
Device Name: MODUS® IMF Screws 2.0
Indications for Use:
MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.
Over-The-Counter Use Prescription Use _X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Runner
vision Sign-Off) Vision Sign-Oh)
vision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: