(127 days)
Not Found
No
The summary describes a physical implant (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a reconstruction plate used in surgery, not a device that provides therapy.
No
Explanation: The device is a preformed reconstruction plate used in oral and maxillofacial surgery for primary mandibular reconstruction and fracture treatment. It is a surgical implant, not a device designed to identify or analyze diseases or conditions.
No
The device description explicitly states that the device is "Synthes MatrixMANDIBLE Preformed Reconstruction Plates" which are physical plates made of titanium or titanium alloy, designed for surgical implantation. This is a hardware device, not software.
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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (reconstruction plates and screws) used to physically repair and stabilize the mandible (jawbone). It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "oral and maxillofacial surgery, trauma and reconstructive surgery," which involves surgical procedures, not diagnostic testing.
Therefore, based on the provided information, the Synthes MatrixMANDIBLE Preformed Reconstruction Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
Product codes
JEY
Device Description
The subject of this 510(k) is the Synthes MatrixMANDIBLE Preformed Reconstruction Plates. These plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
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
oral and maxillofacial surgery, trauma and reconstructive surgery
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 MatrixMANDIBLE Plate and Screw 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.
0
AUG 2 5 2009
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a circle with a design inside. To the right of the word is a circled R symbol. There is a horizontal line below the word.
:
Kog 1144
| 3.0 | 510(k) Summary |
|---|---|
| Page 1 of 1 | |
| Sponsor: | Synthes |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6604 | |
| Contact: | Amnon Talmor |
| Synthes | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6604 | |
| Device Name: | Synthes MatrixMANDIBLE Preformed Reconstruction Plates |
| Classification: | Class II per 21 CFR §872.4760: Plate, Bone |
| Predicate Devices: | Synthes MatrixMANDIBLE Plate and Screw System |
| Device Description: | The subject of this 510(k) is the Synthes MatrixMANDIBLE |
| Preformed Reconstruction Plates. These plates are | |
| anatomically contoured to match the body and angle regions of | |
| the mandible in most patients. These plates are designed for | |
| use with Synthes MatrixMANDIBLE screws that come in | |
| multiple diameters and lengths to meet the anatomical needs of | |
| the patient. System components are manufactured in either | |
| titanium or titanium alloy and are intended for single use only. | |
| Intended Use: | The Synthes MatrixMANDIBLE Preformed Reconstruction |
| Plates are intended for use in oral and maxillofacial surgery, | |
| trauma and reconstructive surgery. This includes primary | |
| mandibular reconstruction, comminuted fractures and temporary | |
| bridging pending delayed secondary reconstruction, including | |
| fractures of edentulous and/or atrophic mandibles, as well as | |
| unstable fractures. | |
| Substantial Equivalence: | Information presented supports substantial equivalence. |
and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
.
. . .
.
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all caps and is arranged in a circular fashion to match the shape of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes USA 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K091144
Trade/Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 12, 2009 Received: August 13, 2009
Dear Ms. Tasker:
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 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. Tasker
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting 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: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Indications for Use: The Synthes MatrixMANDIBLE Preformed Reconstruction Plates
are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
Prescription Use × (Per 21 CFR 801.109)
2.0
AND/OR
Over-The-Counter Use (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)
Reen Muly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: