(182 days)
Not Found
No
The description focuses on mechanical distraction and does not mention any AI/ML components or functions.
Yes
The device is used to increase bone height and mass in patients with edentulous mandibles or maxillae, or craniofacial bone deficiencies, to correct traumatic defects, periodontal disease, or birth abnormalities. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device description states its purpose is to increase bone height and mass through distraction osteogenesis. It is an active medical device used for treatment (gradual expansion across an osteotomy), not for diagnosing conditions.
No
The device description explicitly states it consists of physical components: two bone plates, a threaded rod, and an activation instrument.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a surgical implant used to gradually increase bone height and mass through distraction osteogenesis. It is a mechanical device that is physically placed within the body.
- Intended Use: The intended use describes a surgical procedure and the device's role in that procedure, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the OsteoMed Alveolar Distraction System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This submission describes the OsteoMed Alveolar Distraction System intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The alveolar distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adiacent alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.
Product codes
MQN
Device Description
The OsteoMed Alveolar Distraction System is a distraction osteogenesis system consisting of two bone plates, a threaded rod and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument. The distractor is capable of distraction lengths of up to 20mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or 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)
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
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Alveolar Distraction System
Intraoral Distractor
MQN. External Mandibular Fixator and/or Distractor
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-6401
Contact Person:
Date Prepared:
Dawn T. Holdeman
March 10, 2003
Summary:
This submission describes the OsteoMed Alveolar Distraction System intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The alveolar distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adiacent alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.
The OsteoMed Alveolar Distraction System is a distraction osteogenesis system consisting of two bone plates, a threaded rod and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument. The distractor is capable of distraction lengths of up to 20mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin TRACK 1.0mm and 1.5mm System (K002152), the Leibinger Chin Distractor (K973484), and the Lorenz Distraction System (K992952).
Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/21 description: The image shows a logo with the word "Colson" in a bold, sans-serif font. The word is partially enclosed within a dark circle with a vertical line extending upwards from the top of the word. To the right of the logo, the words "A COL" are visible, also in a sans-serif font, but smaller and less bold than "Colson."
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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 the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
Public Health Service
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K030790
Trade/Device Name: Osteomed Alveolar Distraction System Intraoral Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: June 16, 2003 Received: June 17, 2003
Dear Ms. Holdeman:
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 vour 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.
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Page 2 -Mr. Holdeman
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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Suzafunz
Susan Runner, DDS, MA Interim 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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OsteoMed "Indications for Use" Submission
510(k) Number:
03079
| Device Name: | Osteomed Alveolar Distraction System |
|---|---|
| Indication for Use: | Intended for use in patients who have totally or |
| partially edentulous mandible or maxilla or small | |
| craniofacial bone deficiencies and need an | |
| increase in bone height and mass by means of | |
| distraction osteogenesis. These patients include | |
| those who have traumatic defects, periodontal | |
| disease or birth abnormality. The distractor is | |
| designed to provide temporary stabilization and | |
| gradual expansion across an osteotomy in the | |
| mandibular bone or maxillary bone and thereby | |
| increasing the height of the adjacent Alveolar ridge. | |
| This device is intended to be removed after | |
| consolidation of the callus and prior to final | |
| prosthetic reconstruction. | |
| The OsteoMed Alveolar Distraction System is | |
| intended for single patient use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)
Kein Muly for MSR
(Divis Division of Anesthesiolo Infection Control, Denta
510(k) Number: K030746