(228 days)
Synthes MatrixMANDIBLE Plate and Screw System, MODUS® Titanium Osteosynthesis System
Not Found
No
The summary describes a passive implant (plates and screws) used for fracture fixation. There is no mention of any software, image processing, or data analysis that would typically involve AI/ML.
No
The device is a surgical implant (plates and screws) used for fracture fixation, which is a structural support rather than a device that directly restores or corrects impaired bodily function.
No
The device is a surgical implant (plates and screws) used for treating fractures, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a physical plate made of titanium or titanium alloy, intended 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Synthes MatrixMANDIBLE Subcondylar Plates are physical implants designed to fix fractures in the jawbone. They are used in vivo (within the living body) during surgery.
- Intended Use: The intended use clearly states surgical procedures for fixing bone fractures, not analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical implant or medical device used for orthopedic/maxillofacial procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
Product codes
JEY
Device Description
The Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. 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
subcondylar region of the mandible and condylar basis region of the mandible.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oral, 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, MODUS® Titanium Osteosynthesis System
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a medical device or implant. A small circle with an R inside is located at the top right of the word "SYNTHES".
3.0
DEC 1 1 2009
1091233
ら
510(k) Summary Page _________________________________________________________________________________________________________________________________________________________________________ Sponsor: Synthes 1301 Goshen Parkway West Chester, PA 19380 Contact: Contact: Andrea M. Tasker tasker.andrea@synthes.com (610) 719-6290 Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Classification: Class 11, 21 CFR §872.4760, Bone plate Predicate Synthes MatrixMANDIBLE Plate and Screw System Devices: MODUS® Titanium Osteosynthesis System The Synthes MatrixMANDIBLE Subcondylar Plates are designed Device Description: specifically to match the anatomy of the subcondylar region of the mandible. 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 Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. Substantial Information presented supports substantial equivalence. Equivalence:
PAGE 18
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 image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 1 2009
Ms. Andrea M. Tasker CMF Regulatory Affairs Manager Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K091233
Trade/Device Name: Synthes MatrixMANDIBLE Subcondylar Plates Regulation Number: 21CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 23, 2009 Received: November 25, 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 vours.
Susan Rinner
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
3
SYNTHES®
2.0 Indications for Use
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K091233 |
| Device Name: | Synthes MatrixMANDIBLE Subcondylar Plates |
INDICATIONS FOR USE:
The Synthes MatrixMANDIBLE Subcondylar Plates are intended for
oral, maxillofacial surgery; trauma and reconstructive surgery,
specifically for fractures of the subcondylar region of the mandible and
fractures of the condylar basis region of the mandible.
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091232