(89 days)
Not Found
Not Found
No
The summary describes passive implants (plates) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is described as plates used for trauma, surgery, and reconstructive procedures of the craniofacial skeleton, which suggests it is used to repair or support rather than directly treat a disease or condition in a therapeutic manner.
No
Explanation: The device description states its purpose is for reconstructive procedures and surgeries, not for diagnosing conditions.
No
The device description explicitly states "The Synthes Orbital Plates come in a variety of shapes and sizes" and are "sterile / non-sterile and for single use only," indicating a physical hardware component (plates).
Based on the provided information, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Synthes Craniofacial Plates are implants used for surgical procedures on the craniofacial skeleton. They are physical plates implanted into the body to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, laboratory testing, or providing diagnostic information based on samples.
Therefore, the Synthes Craniofacial Plates are a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Craniofacial Plates are 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
The Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile / non-sterile and 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 Maxillofacial Titanium Micro Set, Synthes Orbital Mesh 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
SEP = 3 2003
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | Synthes (USA) |
|---|---|
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| (610) 647-9700 | |
| Contact: Lisa M. Boyle | |
| DEVICE NAME: | Orbital Plates |
| CLASSIFICATION: | Class II , 21 CFR 888.3030: Single/multiple component metallic bone |
| fixation appliances and accessories | |
| PREDICATE DEVICE: | Synthes Maxillofacial Titanium Micro Set |
| Synthes Orbital Mesh Plates | |
| DEVICE DESCRIPTION: | The Synthes Orbital Plates come in a variety of shapes and sizes to meet the |
| anatomical need of the patient. The plates are sterile / non-sterile and for | |
| single use only. | |
| INTENDED USE: | The Synthes Craniofacial Plates are 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. | |
| MATERIAL: | CP Titanium |
| SUBSTANTIAL | |
| EQUIVALENCE: | Documentation is provided which demonstrates that the Synthes Orbital |
| Plates are substantially equivalent to other legally marketed Synthes | |
| devices. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2003
Ms. Lisa Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K031761
Trade/Device Name: Synthes (USA) New / Sterile Orbital Plates Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 5, 2003 Received: June 6, 2003
Dear Ms. Boyle:
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 -Ms. Boyle
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 Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA Interim 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 Statement 2.0
Page __ 1_________ of ________________________________________________________________________________________________________________________________________________________
:
| 510(k) Number (if known): | K031761 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications:
The Synthes Craniofacial Plates are 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use_ |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K 031761 |
Confidential