(84 days)
Not Found
Not Found
No
The summary describes a system of physical plates and screws for surgical use and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a plate and screw system intended for use in surgical procedures to repair or reconstruct bones, not to treat a disease or condition therapeutically. It provides structural support rather than imparting a therapeutic effect.
No
This device is a surgical implant (plate and screw system) used for reconstructive procedures and trauma stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (plates and screws) made of titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical system for fixing bones in the craniofacial region. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as plates and screws made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.
IVDs are typically used for diagnostic testing performed on samples taken from the body, not for direct surgical repair of the body itself.
N/A
Intended Use / Indications for Use
The 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
Device Description
Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium 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 Orbital 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's wings are stylized and appear to be in motion.
MAY 15 2008
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
Re: K080331
Trade/Device Name: Synthes Craniofacial Plate and Screw System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: April 30, 2008 Received: April 30, 2008
Dear Mr. Talmor:
This letter corrects our substantially equivalent letter of April 30, 2008.
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 (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.
1
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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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) 276-011. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
2
Image /page/2/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. There is a horizontal line under the word "SYNTHES".
Indications for Use
510(k) Number (if known): K080331
Device Name:
Synthes Orbital Plates
Indications:
The 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 × (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)
Senatunner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K0600331
3
Image /page/3/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. The circular symbol contains a stylized image of a screw or bolt. There is a registered trademark symbol next to the "S" at the end of the word SYNTHES.
3.0 510(k) Summary
Page 1
Sponsor:
Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-5000
Amnon Talmor, Regulatory Affairs Specialist Phone: (610) 719-6604 FAX: (484) 356-9682 talmor.amnon@synthes.com
Device Name: Classification: Synthes (USA) Craniofacial Plate and Screw System Class II per 21 CFR §872.4760;
Plate, Fixation, Bone; Product Code JEY
Synthes Craniofacial Plate and Screw System
Predicate Device:
Device Description: Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.
Intended Use:
Substantial Equivalence: The 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.
Documentation is provided that demonstrates the Synthes Orbital Plates are substantially equivalent to other legally marketed devices.