(69 days)
Not Found
Not Found
No
The device description and intended use focus on physical implants (plates and screws) and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as plates and screws intended for trauma, reconstructive procedures, and surgery, which are generally considered structural support or fixation devices rather than devices that provide therapy to treat a disease or condition.
No
The device description indicates that the system consists of plates and screws used for treatment and reconstruction, not for diagnosing conditions.
No
The device description clearly states it consists of physical plates and screws made of titanium or titanium alloy, 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Synthes Craniofacial Plate and Screw System clearly indicate it is a surgical implant used to stabilize bones in the craniofacial region. It is used in the body, not to test samples from the body.
Therefore, based on the provided information, the Synthes Craniofacial Plate and Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Synthes Craniofacial Plate and Screw 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 and chin.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. 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
midface and craniofacial skeleton, maxilla and chin
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): 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 Midfacial System, Synthes Orbital Mesh Plates F/Synthes Midfacial System, Synthes Maxillofacial Titanium Micro Set, Synthes Cranial Plates, Synthes 1.5 mm Self-tapping cortex screws
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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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A horizontal line is present beneath the word, and a registered trademark symbol is located to the right of the word.
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510(k) Summary 3.0
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Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5000 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Craniofacial Plate and Screw System |
| Classification: | Class II, 21 CFR §872.4760
Bone plate |
| | Class II, 21 CFR §872.4880
Intraosseous fixation screw or wire |
| Predicate Device: | Synthes Midfacial System
Synthes Orbital Mesh Plates F/Synthes Midfacial System
Synthes Maxillofacial Titanium Micro Set
Synthes Cranial Plates
Synthes 1.5 mm Self-tapping cortex screws |
| Device Description: | Synthes Craniofacial Plate and Screw System consist of plates and
meshes that come in a variety of shapes and sizes to meet the
anatomical needs of the patient. This system is designed for use
with 1.8 mm screws and 2.1 mm emergency screws. The screws
will be used with Synthes 1.8 mm hexagonal screwdriver blades.
System components are manufactured in either titanium or titanium
alloy and are intended for single use only. |
| Intended Use: | Synthes Craniofacial Plate and Screw 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 and chin. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that the Synthes
Craniofacial Plate and Screw 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K050608
Trade/Device Name: Synthes (USA) Craniofacial Plate and Screw Systems Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: March 9, 2005 Received: March 10, 2005
Dear Ms. Musgnung:
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 (111), and 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 Eederal Register.
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Page 2 - Ms. Musgnung
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 (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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 registered trademark symbol is located to the right of the word. The word is underlined with a thin black line.
Indications for Use
510(k) Number (if known):
Device Name:
Indications:
Kosopor
Synthes (USA) Craniofacial Plate and Screw System
Synthes Craniofacial Plate and Screw 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 and chin.
Prescription Use X (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 Russe
15000
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number.__
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