(115 days)
Synthes Craniofacial Plates
Not Found
No
The provided text describes a plating system for orthopedic surgery and does not mention any AI or ML components.
No
The device is a plating system used for internal fixation in reconstructive and orthognathic surgeries, not for alleviating or curing a disease or condition in a therapeutic sense, but rather for stabilization after trauma or surgical procedures.
No
The device is a plating system used for surgical fixation of bones in the midface and craniofacial skeleton. Its intended uses are for trauma, reconstructive procedures, and orthognathic surgery, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states that the system consists of physical plates and screws made of titanium or titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for fixing bones in the midface and craniofacial skeleton. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device consists of plates and screws, which are physical implants used in surgery. This is consistent with a surgical device, not an IVD which typically involves analyzing samples from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, the Synthes MatrixORTHOGNATHIC Plating System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific Indications for Use:
- Fractures of the midface and craniofacial skeleton
- LeFort I osteotomies, sagittal split osteotomies and genioplasties
- Orthognathic surgery including reconstructive procedures
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
midface and craniofacial skeleton, maxilla, mandible, chin
Indicated Patient Age Range
adolescents (greater than 12 to 21 years of age) and adults.
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): 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.
Synthes Craniofacial Plates
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.
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Page 1 _______________________________________________________________________________________________________________________________________________________________________ of 510(k) Summary 3.0 Synthes (USA) Sponsor: 1301 Goshen parkway West Chester, PA 19380 Contact: Andrea M. Tasker (610) 719-6290 Synthes MatrixORTHOGNATHIC Plating System Device Name: Class II; 21 CFR §872.4760, Bone plate Classification: Class II, 21 CFR §872.4880, Intraosseous fixation screw or wire Synthes Craniofacial Plates Predicate Device: Synthes Craniofacial Plate and Screw System Synthes 1.5mm/2.0mm Orthognathic Maxillary Plates Synthes SMF Titanium Alloy Bone Screws Xsorb™ Bioabsorbable Craniofacial Fixation System The Synthes MatrixORTHOGNATHIC Plating System consists of Device Description: a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only. The Synthes MatrixORTHOGNATHIC Plating System is intended Intended Use: for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: Fractures of the midface and craniofacial skeleton . LeFort I osteotomies, sagittal split ostcotomies and . genioplasties Orthognathic surgery including reconstructive procedures . Substantial Documentation is provided in this submission which demonstrates Equivalence: that the Synthes MatrixORTHOGNATHIC Plating System is substantially equivalent to other legally marketed devices.
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2009
Ms. Andrea M. Tasker Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K083388
Trade/Device Name: Synthes MatrixORTHOGNATHIC Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 14, 2009 Received: January 14, 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 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.
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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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,
Susan Pomona
Ginette Y. Michaud, M.D. 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
Ko 8 3388
510(k) Number (if known):
Device Name:
Indications:
Synthes MatrixORTHOGNATHIC Plating System
The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific Indications for Use:
- Fractures of the midface and craniofacial skeleton
- LeFort I osteotomies, sagittal split osteotomies and genioplasties
- Orthognathic surgery including reconstructive procedures
× Prescription Use (Per 21 CFR 801 Subpart D) 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)
Susan Dunner
.. VISION SIGN-Off) nvision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K063386