(88 days)
Synthes MatrixMANDIBLE Plate and Screw System, Synthes SMF Self-Drilling Screws
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 AI/ML.
No
The device is a system of plates and screws used for surgical fixation, which is a structural support rather than a direct therapeutic intervention.
No
Explanation: The device is a plate and screw system for surgical use, not for diagnosing conditions. It is described as a system of implants used in oral and maxillofacial surgery for trauma, reconstructive surgery, and orthognathic surgery.
No
The device description clearly states it is a "Plate and Screw System" and describes physical implants made from titanium, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states surgical procedures on the mandible (oral, maxillofacial surgery, trauma, reconstructive surgery, orthognathic surgery). This involves direct intervention on the patient's body.
- Device Description: The device is described as plates and screws made of titanium, designed for surgical implantation. This is a surgical implant, not a diagnostic tool used on in vitro samples (like blood, urine, or tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to fix bone structures.
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 incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial
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 MatrixMANDIBLE Plate and Screw System, Synthes SMF Self-Drilling Screws
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
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. A horizontal line runs beneath the word "SYNTHES". There is a registered trademark symbol to the right of the word.
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:
Ko 82 3 35
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6604 | ||
| Contact: | Amnon Talmor | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6604 | ||
| NOV 10 2008 | ||
| Device Name: | Synthes MatrixMANDIBLE Plate and Screw System | |
| Classification: | Class II per 21 CFR §872.4880: Screw, Fixation, Intraosseous | |
| Predicate Devices: | Synthes MatrixMANDIBLE Plate and Screw System | |
| Synthes SMF Self-Drilling Screws | ||
| Device Description: | The Synthes MatrixMANDIBLE Plate and Screw System | |
| incorporates small, medium and large plates designed so all | ||
| plates accept all system screws. The plates are available in | ||
| various shapes and thicknesses and accept self-tapping and | ||
| self-drilling cortex and locking screws. The implants are | ||
| manufactured from titanium. | ||
| 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. |
:
and the comments of the comments of
1
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Amnon Talmor Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
NOV 1 0 2008
Re: K082335
Trade/Device Name: Synthes MatrixMANDIBLE Plate and Screw System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 13, 2008 Received: August 14, 2008
Dear Mr. Talmor:
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 -- Mr. Talmor
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 (OS) regulation (21 CFR Part 820): and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Super Linnes
Chiu S. Lin, Ph. D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 horizontal line is present underneath the word "SYNTHES".
2.0
KO22335 510(k) Number (if known): Device Name: 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).
Indications for Use
Prescription Use (Per 21 CFR 801.109)
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)
Suriano
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K082338