(353 days)
Not Found
No
The summary describes a mechanical plate and screw system for surgical fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a system of plates and screws used for oral and maxillofacial surgeries such as trauma, reconstructive surgery, and orthognathic surgery, which are all therapeutic interventions.
No
The device is a system of plates and screws used for fixation in oral and maxillofacial surgery (trauma, reconstructive surgery, orthognathic surgery). It does not perform any diagnostic function.
No
The device description explicitly states it consists of physical plates and screws made from titanium, 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.
- Device Description and Intended Use: The provided text clearly describes a system of plates and screws intended for surgical implantation to treat trauma, reconstructive needs, and orthognathic deformities in the mandibular bone. This is a surgical implant, not a device used for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the Synthes MatrixMANDIBLE plate and screw system is a surgical implant, 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
- Orthognathic surgery (surgical correction of dentofacial deformities)
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.
This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use).
MatrixMANDIBLE 1.5 mm thick reconstruction plates 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
mandibular bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oral, maxillofacial 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)
An engineering assessment, including a cross section analysis and finite element analysis, was used to compare the 1.5 mm thick MatrixMANDIBLE Reconstruction Plates to the predicate devices. The c analysis determined that the in-plane and out-of-plane mechanical properties of the 1.5 mm thick MatrixMANDIBLE Reconstruction Plates are comparable to the in-plane and out-of-plane mechanical properties for the predicate Synthes 2.0 mm Locking Plate System (K974555).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
Page 1 of 3
| Date Prepared | November 15, 2012 | |
|---|---|---|
| Submitter | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| United States of America | NOV 1 9 2012 | |
| Contact | Alan T. Haley | |
| haley.alan@synthes.com | ||
| (484) 356-9763 | ||
| Trade Name | MatrixMANDIBLE Plate and Screw System | |
| Common Name | Bone Plate | |
| Classification Name | Bone Plate, 21 CFR 872.4760, Product Code JEY | |
| Predicate Devices | MatrixMANDIBLE Plate and Screw System (K063790) | |
| Synthes 2.0 mm Locking Plate System (K974555) |
Intended Use
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
- . Trauma
- . Reconstructive surgery
- . Orthognathic surgery (surgical correction of dentofacial deformities)
Device Description
The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.
This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile (non-sterile implants must be sterilized prior to use).
MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.
1
Image /page/1/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 stylized figure inside. The logo appears to be a person with a round head and a body that resembles a vase or pot. The word "SYNTHES" is written in a sans-serif font and has a slightly italicized appearance.
510(k) Summarv
Comparison to Predicate Devices
Indications for Use
The Indications for Use statement for the proposed device is identical to the Indications for Use statement for the Synthes MatrixMANDIBLE Plate and Screw System predicate (K063790).
The Indications for Use statement for the proposed device is similar to the Indications for Use statement for the Synthes 2.0 mm Locking Plate System predicate (K974555). Both statements include oral, maxillofacial surgery, trauma, reconstructive surgery, and surgical correction of dentofacial deformities.
The differences in the Indications statement for the proposed device in comparison to the predicates do not constitute a new intended use.
Technological Similarities
- . The proposed device has the same principles of operation (metallic plate used for the internal fixation of mandibular bone) as the predicate devices.
- . The proposed device is offered in single angle (right and left) and double angle (three sizes) configurations; the predicate devices are offered in the same configurations.
- . The double angle configurations of the proposed device have the same number of holes as the double angle configurations of the predicate devices.
- . The single angle configurations of the proposed device have number of holes as the single angle configurations of the Synthes MatrixMANDIBLE Plate and Screw System predicate (K063790).
- . The proposed device is made of the same material (titanium) as the predicate devices.
- The thickness of the proposed device is within the range of thicknesses as the predicate devices. .
- . The proposed device and the predicate devices have threaded static locking screw holes.
- . The proposed device is compatible with the same MatrixMANDIBLE screws as the Synthes MatrixMANDIBLE Plate and Screw System predicate (K063790).
Technological Differences
- . The width of the proposed devices is slightly greater than the width of the predicate devices.
- In addition to the single and double angle configurations, the predicate devices are offered in a . straight (no angle) configuration. The proposed device is not offered in a straight configuration.
- . The single angle configurations of the proposed device have one more hole and are slightly longer than the single angle configurations of the Synthes 2.0 mm Locking Plate System predicate (K974555).
2
Image /page/2/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 small circle with an "R" in it is to the right of the word.
510(k) Summary
Non-Clinical Performance Data
An engineering assessment, including a cross section analysis and finite element analysis, was used to compare the 1.5 mm thick MatrixMANDIBLE Reconstruction Plates to the predicate devices. The c analysis determined that the in-plane and out-of-plane mechanical properties of the 1.5 mm thick MatrixMANDIBLE Reconstruction Plates are comparable to the in-plane and out-of-plane mechanical properties for the predicate Synthes 2.0 mm Locking Plate System (K974555).
Clinical Performance Data
No clinical testing was performed to support this submission.
Substantial Equivalence
The proposed devices have the same intended use as the predicate devices. The non-clinical performance data included in this submission demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the predicate devices. It is concluded that the information included in this submission supports substantial equivalence.
(end of summary)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem is a graphic representation of an eagle, with three curved lines forming the body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 19, 2012
Mr. Alan T. Haley Regulatory Affairs Specialist Synthes® Incorporated 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K113567 -
Trade/Device Name: MatrixMANDIBLE Plate and Screw System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 9, 2012 Received: November 13, 2012
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.
4
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 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300 092402
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
SYNTHES.
4 Indications for Use Statement
510(k) Number (if known):
KII 3567
Device Name:
MatrixMANDIBLE Plate and Screw System
Indications for Use:
The Synthes MatrixMANDIBLE plate and screw system is intended for oral, maxillofacial surgery:
- Trauma .
- Reconstructive surgery �
- . Orthognathic surgery (surgical correction of dentofacial deformities)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Mary S.
Runner
Digitally signed by Mary S. Runner
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner,
0.9.2342.19200300.100.1.1=1300087950
Date: 2012.11.19 10:09:23 -05'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K113567
Synthes MatrixMANDIBLE Plate and Screw System, Additional Plates