(87 days)
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.
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.
I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) summary for the OsteoMed 2.0 Locking Plate System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of materials, design, and intended use.
The document does not contain any information about acceptance criteria for device performance, nor does it describe any study related to proving such criteria for the OsteoMed 2.0 Locking Plate System. This is typical for 510(k) submissions where clinical studies or performance testing against specific acceptance criteria for aspects like diagnostic accuracy (which would involve AI, human readers, ground truth, etc.) are generally not required unless new safety or effectiveness issues are raised.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details (effect size, human readers with/without AI).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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MAY - 9 2003
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K0 30448
510(k) Summary
| Device Proprietary Name: | OsteoMed 2.0 Locking PlateSystem |
|---|---|
| Device Common Name: | Bone Plate System |
| Classification Name: | Plate, Bone |
| Name of Submitter: | OsteoMed L. P.3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (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.
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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 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.
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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
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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). 2.0Locking plates and screws are intended for singlepatient 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
§ 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.