(115 days)
The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
The Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.
The provided text describes a medical device submission (K063790) for "The Synthes MatrixMANDIBLE Plate and Screw System". This document is a 510(k) summary and the FDA's clearance letter.
Based on the provided text, there is no information available about acceptance criteria, detailed device performance studies, sample sizes for testing or training, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.
The document does state that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This equivalence is typically established through a comparison of technological characteristics, intended use, and performance data if applicable, but the specifics of how performance was evaluated are not detailed in this summary.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided input.
The information you are requesting would typically be found in a more comprehensive clinical or non-clinical performance study report, which is not part of this 510(k) summary.
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-5000 | |
| Contact: | APR 16 2007Deborah L Jackson, RACSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6948 | |
| Device Name: | The Synthes MatrixMANDIBLE Plate and Screw System | |
| Classification: | 21 CFR 872.4760: Bone plate | |
| Predicate Devices: | Synthes 2.4 mm Universal Locking Plate SystemSynthes 2.0 Locking Plate SystemSynthes Mandibular Modular Fixation SystemStryker Leibinger NewGen System | |
| Device Description: | The Synthes MatrixMANDIBLE Plate and Screw System is thenext generation of Synthes (USA) fixation systems for themandible. The system incorporates small, medium, and largeplates designed so that all plates accept all system screws. Theplates are available in various shapes and thicknesses, and acceptself-tapping cortex and locking screws.The implants aremanufactured from CP titanium and titanium alloy. | |
| Intended Use: | The Synthes MatrixMANDIBLE Plate and Screw System isintended for oral, maxillofacial surgery; trauma; reconstructivesurgery; and orthognathic surgery (surgical correction ofdentofacial deformities). | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah L. Jackson Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
APR 16 2007
Re: K063790
Trade/Device Name: The Synthes MatrixMANDIBLE Plate and Screw System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 30, 2007 Received: April 2, 2007
Dear Ms. Jackson:
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.
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Page 2 - Ms. Jackson
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snyte Y. Michael Omd.
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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Page 1 of
2.0 Indications for Use
| 510(k) Number (if known): | K063790 |
|---|---|
| Device Name: | The Synthes MatrixMANDIBLE Plate and Screw System |
| Indications for Use: | The Synthes MatrixMANDIBLE Plate and Screw System isintended for oral, maxillofacial surgery; trauma; reconstructivesurgery; and orthognathic surgery (surgical correction ofdentofacial deformities). |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR Over-The-Counter Use (Per 21 CFR 801.109) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
Son of Anactherintogy, General Hospital, Jon Control, Deman Devices
) Number: KD63790
§ 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.