(48 days)
Not Found
No
The summary describes a physical medical device (reconstruction plates and screws) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a reconstruction plate used for primary mandibular reconstruction and fracture fixation. It provides mechanical support and stabilization but does not directly treat or cure a disease or condition in a therapeutic sense.
No
The device is a reconstruction plate used in surgery to stabilize the mandible, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the device is a physical plate made of titanium or titanium alloy, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in oral and maxillofacial surgery, trauma, and reconstructive surgery, specifically for primary mandibular reconstruction and fracture treatment. This involves direct surgical intervention on the patient's body.
- Device Description: The device is described as preformed reconstruction plates designed to be implanted in the mandible. This is a surgical implant, not a diagnostic tool used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support and reconstruction within the body.
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 Synthes MatrixMANDIBLE Preformed Reconstruction 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
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)
Synthes conducted the following non-clinical testing: dynamic and static testing. The conclusions drawn from testing demonstrate that the MatrixMANDIBLE Preformed Reconstruction Plates maintain a significantly longer fatigue life compared to the 2.5mm thick MatrixMANDIBLE plates when tested under similar loading conditions. Clinical data was not needed for this device.
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
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
SYNTHES
CMF
......
510(k) Summary -- MatrixMANDIBLE Preformed Reconstruction Plates 2.2
| Name of Firm: | Synthes
1301 Goshen Parkway
West Chester, PA 19380 |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Elizabeth Kierzek
Associate Regulatory Affairs Specialist
Phone: 610-719-6565
Fax: 484-356-9682
Email: Kierzek.Elizabeth@synthes.com |
| Date Prepared: | November 1, 2011 |
| Device Trade Name: | Synthes MatrixMANDIBLE Preformed Reconstruction
Plates |
| Device Generic Name: | Plate, bone |
| Product Code: | JEY |
| Regulation Number: | 872.4760 |
| Predicate Devices: | Synthes MatrixMANDIBLE Preformed
Reconstruction Plates (K091144) |
| Device Description: | The Synthes MatrixMANDIBLE Preformed
Reconstruction 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 /
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. |
| Comparison of the
technological
characteristics of the device
to the predicate device: | The design features, material, and indications for use of
the subject MatrixMANDIBLE Preformed
Reconstruction Plates are substantially equivalent to
the predicate device identified. Additionally, the safety
and effectiveness of this system is adequately
supported by documentation within this submission. |
| Performance Data
(Nonclinical and/or
Clinical): | Synthes conducted the following non-clinical testing:
dynamic and static testing. The conclusions drawn
from testing demonstrate that the MatrixMANDIBLE
Preformed Reconstruction Plates maintain a
significantly longer fatigue life compared to the 2.5mm
thick MatrixMANDIBLE plates when tested under
similar loading conditions. Clinical data was not
needed for this device. |
.
1
SYNTHES
CMF
·
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,
.
7
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alan Haley Regulatory Affairs Specialist Synthes Incorporated 1302 Goshen Parkway · West Chester, Pennsylvania 19380
DEC 2 1 2011
Re: K113251
Trade/Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 12, 2011 Received: December 14, 2011
Dear Mr. Haley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Mr. Haley
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 ( 1 c 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 /ucm 1 1 5809.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,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement 9
510(k) Number:
KITZƏZ (if known)
Device Name: Synthes MatrixMANDIBLE Preformed Reconstruction Plates
Indications for Use:
The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in The Syllines MatrixMDDDD Frea and reconstructive surgery. This includes primary oral and maxmonolar bargery, adminuted fractures and temporary bridging pending delayed mandibular reconstruction, voluming fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
X Prescription Use (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruover
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113251