(87 days)
Not Found
No
The summary describes a system of physical plates, screws, and instruments for surgical procedures, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a system of plates and screws used for fixation in oral and maxillofacial surgery, which are structural devices, not inherently therapeutic in function.
No
The device is described as a "Locking Plate System" comprised of plates and screws intended for surgical procedures like oral, maxillofacial surgery, trauma, and reconstructive surgery. Its function is to provide skeletal fixation rather than to diagnose a condition.
No
The device description explicitly lists physical components such as plates, screws, screwdrivers, drills, plate cutters, bending pliers, taps, and drill guides, indicating it is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures (oral, maxillofacial surgery, trauma, reconstructive surgery, orthognathic surgery). This involves direct intervention on the patient's body.
- Device Description: The device is described as plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
Indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0 Locking plates and screws are intended for single patient use only.
Product codes
JEY
Device Description
The OsteoMed 2.0 Locking Plate System is comprised of plates, 1.0mm through 2.25mm thick, provided in various shapes and sizes, and screws provided in 2.0mm diameter in lengths ranging from 6.0mm. System instruments include screwdrivers, drills, plate cutters, bending pliers, taps and drill guides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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
MAY - 9 2003
Image /page/0/Picture/1 description: The image shows the word "OSTEOMED" in bold, black letters. The word is slightly slanted upwards from left to right. There is a thick, black oval shape that surrounds the word, adding emphasis to the brand name. The logo appears to be a company or product name, possibly related to medical or orthopedic fields.
K0 30448
510(k) Summary
| Device Proprietary Name: | OsteoMed 2.0 Locking Plate
System |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Bone Plate System |
| Classification Name: | Plate, Bone |
| Name of Submitter: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 6, 2003 |
Summary:
This submission describes the OsteoMed 2.0 Locking Plate System indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0mm Locking Plates and screws are intended for single patient use only.
The OsteoMed 2.0 Locking Plate System is comprised of plates, 1.0mm through 2.25mm thick, provided in various shapes and sizes, and screws provided in 2.0mm diameter in lengths ranging from 6.0mm. System instruments include screwdrivers, drills, plate cutters, bending pliers, taps and drill guides.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes 2.0 Locking Plate System (K974555), the Stryker Locking Screw Mandibular Reconstruction Plate(K000594), and the Stryker Leibinger Newgen/Universal Mandibular System(K014263).
Due to the similarity of materials and design to predicate devices. OsteoMed believes that the OsteoMed 2.0 Locking Plate System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/11 description: The image shows a logo with the text "Colson" in a stylized font inside a black circle. To the right of the circle, the text "A COLSON ASSOCIATE" is written in a simple, sans-serif font. The text is arranged in a way that emphasizes the "Colson" name, while the "A COLSON ASSOCIATE" text provides additional context.
1
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 a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs & Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K030448
Trade/Device Name: OsteoMed 2.0 Locking Plate system Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 6, 2003 Received: February 11, 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.
2
Page 2 - Ms. 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 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 (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 yours.
Susan Runner
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
3
OsteoMed "Indications for Use" Submission
510(k) Number:
| Device Name: | OsteoMed 2.0 Locking Plate System |
|---|---|
| Indication for Use: | Indicated for oral, maxillofacial surgery; trauma; |
| reconstructive surgery; and orthognathic surgery | |
| (surgical correction of dentofacial deformities). 2.0 | |
| Locking plates and screws are 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 Muhy for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K030448