(115 days)
Not Found
Not Found
No
The device description focuses on the physical components (plates and screws) and their materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is a system of plates and screws used in oral and maxillofacial surgery, trauma, and reconstructive surgery, which are therapeutic interventions.
No
The device description indicates that the Synthes MatrixMANDIBLE Plate and Screw System is a fixation system for the mandible, used in various surgical procedures. It is composed of plates and screws and is manufactured from titanium. Its intended use is for surgical correction, and there is no mention of it being used to identify or analyze a condition.
No
The device description explicitly states it is a "Plate and Screw System" and describes physical implants made of CP titanium and titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Synthes MatrixMANDIBLE Plate and Screw System is a system of plates and screws intended for surgical implantation to fix bones in the mandible. This is a surgical device used within the body.
- Intended Use: The intended use is for surgical procedures (oral, maxillofacial, trauma, reconstructive, orthognathic surgery), not for performing diagnostic tests on samples.
Therefore, based on the provided information, the Synthes MatrixMANDIBLE Plate and Screw System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Product codes
JEY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible
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)
Synthes 2.4 mm Universal Locking Plate System, Synthes 2.0 Locking Plate System, Synthes Mandibular Modular Fixation System, Stryker Leibinger NewGen System
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. To the right of the word is the registered trademark symbol. A horizontal line is underneath the word.
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Contact: | APR 16 2007 | |
| Deborah L Jackson, RAC | ||
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West 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 System | |
| Synthes 2.0 Locking Plate System | ||
| Synthes Mandibular Modular Fixation System | ||
| Stryker Leibinger NewGen System | ||
| Device Description: | 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. | ||
| Intended Use: | The Synthes MatrixMANDIBLE Plate and Screw System is | |
| intended for oral, maxillofacial surgery; trauma; reconstructive | ||
| surgery; and orthognathic surgery (surgical correction of | ||
| dentofacial deformities). | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
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.
2
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
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 is |
| intended for oral, maxillofacial surgery; trauma; reconstructive | |
| surgery; and orthognathic surgery (surgical correction of | |
| dentofacial 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