(70 days)
Not Found
No
The description focuses on mechanical components for bone distraction and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for bone elongation to correct congenital deficiencies, mandibular hypoplasia, or post-traumatic defects of the mandible, which are therapeutic interventions.
No
The device is described as an external distraction osteogenesis system for bone elongation and correction of mandibular defects, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly details physical components like distraction rods, pin clamps, and a hex driver, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Description: The OsteoMed External Mandibular Distraction System is a physical device used for bone elongation and correction of mandibular deficiencies. It is surgically implanted or attached externally to the patient's jaw.
- Intended Use: The intended use is for the physical manipulation and growth of bone, not for testing or analyzing biological samples.
Therefore, this device falls under the category of a surgical or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction.
The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients.
The OsteoMed External Mandibular Distraction System is intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
MQN
Device Description
This submission describes the OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction. This system is intended for use in either adults or pediatric patients. The OsteoMed External Mandibular Distraction System is intended for single patient use only.
The OsteoMed External Mandibular Distraction System is comprised of interchangeable distraction rods that connect to a posterior and anterior pin clamp, and/or the middle link. The anterior pin clamp can accommodate variations in pin placement. The pin clamps will accept 1.6 mm to 3.2 mm pins and lock to the pins via screws. The interchangeable distraction rods are available in various lengths for distraction up to 70 mm. The distraction rods are activated by a hex driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible
Indicated Patient Age Range
adults or pediatric patients
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.
K034027, K994154, K981362, K992873
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
K 063792
Image /page/0/Picture/1 description: The image shows the logo for Osteomed. The logo is black and white and features the word "OSTEOMED" in bold, sans-serif font. The word is enclosed in a black oval shape. The oval shape is slightly tilted upwards.
510(k) Summary
MAR 02 2007
| Device Proprietary Name: | OsteoMed External Mandibular
Distraction System |
|--------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Common Name: | External Distraction System |
| Classification Name: | MQN, External Mandibular
Fixation and/or Distractor |
| Sponsor: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Piedad Peña |
| Date Prepared: | February 14, 2007 |
Summary:
This submission describes the OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction. This system is intended for use in either adults or pediatric patients. The OsteoMed External Mandibular Distraction System is intended for single patient use only.
The OsteoMed External Mandibular Distraction System is comprised of interchangeable distraction rods that connect to a posterior and anterior pin clamp, and/or the middle link. The anterior pin clamp can accommodate variations in pin placement. The pin clamps will accept 1.6 mm to 3.2 mm pins and lock to the pins via screws. The interchangeable distraction rods are available in various lengths for distraction up to 70 mm. The distraction rods are activated by a hex driver.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin 3DX External Distraction System (K034027), the KLS-Martin LP, MOD Line of Molina Distractors 51-600 Series (K994154), Synthes (USA) External Multi Vector Mandible Distractor (K981362), and Lorenz External Mandibular Distractor (K992873).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed External Mandibular Distraction System, which includes adult and pediatric patients, does not raise any new safety or effectiveness issues.
Image /page/0/Picture/11 description: The image shows a logo with the word "Colson" inside a black circle. A white line runs vertically through the word. To the right of the circle, the text "A COLSON ASSOC" is written in a smaller, sans-serif font. The logo appears to be for a company or organization named Colson Associates.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its wings or feathers. The text is in all caps and reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 2 2007
Ms. Piedad Peña Regulatory Affairs Associate OsteoMed L.P. 3885 Arapaho Road Addison. Texas 75001
Re: K063792
Trade/Device Name: OsteoMed External Mandibular Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 14, 2006 Received: December 22, 2006
Dear Ms. Pena:
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.
2
Page 2 - Ms. Pena
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.
Sudite Y. Michie Dmd
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
3
Indications for Use
510(k) Number (if known): _
Device Name: OsteoMed External Mandibular Distraction System
Indications for Use:
The OsteoMed External Mandibular Distraction System, which is a family of external distraction osteogenesis devices for bone elongation for the correction of congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible that require gradual distraction.
The OsteoMed External Mandibular Distraction System is intended for use in either adults or pediatric patients.
The OsteoMed External Mandibular Distraction System is intended for single patient use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of _
(Posted November 13, 2003)
Susan Cunnon
nelel Hospial.
R063792