(35 days)
Not Found
Not Found
No
The device description focuses on mechanical components (plates, cylinders, screws, extensions) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as a "subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses," which are therapeutic interventions. Its primary purpose is to gradually distract bone for corrective purposes, addressing conditions like hemifacial microsomia and mandibular hypoplasia.
No
Explanation: The device description clearly states its purpose is for "gradual bone distraction osteogenesis and for corrective osteotomies," which are surgical treatment procedures, not diagnostic ones.
No
The device description explicitly details physical components made of titanium and steel, such as plates, cylinders, and extensions, which are implanted in the body. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, 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 Modus® Modular Distraction Osteogenesis System is a surgical implant used to gradually lengthen bone in the maxillofacial region. It is physically implanted into the patient's body and directly interacts with bone tissue.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or providing diagnostic information based on laboratory tests.
Therefore, the Modus® Modular Distraction Osteogenesis System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Modus Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, LeFort I and LeFort II/III advancements.
Product codes (comma separated list FDA assigned to the subject device)
MQN
Device Description
Modus Plates
The Modus plates are used with the Modus Distraction Cylinders for various applications of the maxillofacial bone structures. The Modus plates are offered in a variety of sizes and are designed to fit the anatomy of the mandible and/or maxilla and allow adjustment of the vector by intra-operative bending if indicated.
Modus Distraction Cylinders
The Modus Distraction Cylinders are used with the Modus plates and screws for gradual bone distraction osteogenesis and for corrective osteotomies of the mandible and maxilla. The Modus distraction cylinders are available in uni-directional or bi-directional with multiple distraction lengths.
Modus Flexible Extensions
Flexible extensions are to be used with distraction cylinders if needed. The extensions allow additional access for distraction of the surgical site.
Material Composition
The implant plates and ARS distractors are made of CP titanium Grade 4 and comply with ASTM F 67 standards for unalloyed titanium for surgical implant applications. The MDO distraction cylinders and flexible extensions are made of implant steel that complies with ASTM F 138 or ASTM F 139.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible and maxilla
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
§ 872.4760 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® Modular Distraction Osteogenesis System
510(k): Summary
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis, Inc.
127 W Street Road, Suite 203
Kennett Square, PA 19348
Telephone (610) 961-6101
FAX (610) 961-6108 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kate Gehret |
| 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 |
Classification Name: External Mandibular Fixator and/or Distractor Modus Modular Distraction Osteogenesis System Trade/Proprietary Name: Mandibular Fixator and Distractor Common Name:
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 bone fixation plates as Class II devices (21 CFR 872.4760). The product code for external mandibular fixator and/or distractor is MQN. This device classification is reviewed by the Dental Devices Branch.
INTENDED USE
The Modus Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar
1
K 05 1946
510(k): Summary
Modus® Modular Distraction Osteogenesis System
ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, LeFort I and LeFort II/III advancements.
DEVICE DESCRIPTION
Modus Plates
The Modus plates are used with the Modus Distraction Cylinders for various applications of the maxillofacial bone structures. The Modus plates are offered in a variety of sizes and are designed to fit the anatomy of the mandible and/or maxilla and allow adjustment of the vector by intra-operative bending if indicated.
Modus Distraction Cylinders
The Modus Distraction Cylinders are used with the Modus plates and screws for gradual bone distraction osteogenesis and for corrective osteotomies of the mandible and maxilla. The Modus distraction cylinders are available in uni-directional or bi-directional with multiple distraction lengths.
Modus Flexible Extensions
Flexible extensions are to be used with distraction cylinders if needed. The extensions allow additional access for distraction of the surgical site.
Material Composition
The implant plates and ARS distractors are made of CP titanium Grade 4 and comply with ASTM F 67 standards for unalloyed titanium for surgical implant applications. The MDO distraction cylinders and flexible extensions are made of implant steel that complies with ASTM F 138 or ASTM F 139.
EQUIVALENCE TO MARKETED PRODUCT
For the purposes of FDA's regulation of medical devices, the Modus Distraction System is substantially equivalent in indications and design principles to the predicate devices, that have been determined by FDA to be substantially equivalent to pre-amendment devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Medartis, Incorporated C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K051946
Trade/Device Name: Modus Modular Distraction Osteogenesis System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: July 15, 2005 Received: July 19, 2005
Dear Mr. Larson:
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 - 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 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 yours,
Susan Runner
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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Indications for Use
510(k) Number (if known): _ K 051946
Device Name: Modus Modular Distraction Osteogenesis System
Indications for Use:
The Modus® Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, and LeFort I, and LeFort II/III advancements.
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)
SkenRunger
Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devic
510(k) Number. K051946