(30 days)
Not Found
Not Found
No
The summary describes a mechanical implant (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a craniofacial plate used for fixation in trauma and reconstructive surgery; it serves as a structural support rather than providing therapy.
No
The device is described as plates and screws used for trauma and reconstructive procedures, not for identifying a disease or condition.
No
The device description clearly states it is a physical plate with threaded holes for screws, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for surgical procedures on the craniofacial skeleton. This is a direct intervention on the patient's body.
- Device Description: The device is described as plates and screws used for fixation. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted or used directly in surgical procedures on the body itself.
N/A
Intended Use / Indications for Use
Synthes 2.0 mm Craniofacial Locking Plates are indicated for 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)
MON, JEY
Device Description
Synthes 2.0 mm Craniofacial Locking Plates provide a locking screw/plate interface. The plates contain threaded holes which allow the use of 2.0 mm Locking screws, 2.0 mm Cortex screws and 2.4 mm Emergency screws.
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 2.0 mm Craniofacial Plates and Synthes 2.0 mm Mandible Locking 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
OCT 2 9 2003
3. 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Bonnie J. Smith |
| Device name: | 2.0 mm Craniofacial Locking Plates |
| Classification: | Class II, §872,4760 - Plate, fixation, bone. |
| Intended use: | Synthes 2.0 mm Craniofacial Locking Plates are indicated for
selective trauma of the midface and craniofacial skeleton;
craniofacial surgery, reconstructive procedures; and selective
orthognathic surgery of the maxilla and chin. |
| Predicate device(s): | Synthes 2.0 mm Craniofacial Plates and Synthes 2.0 mm
Mandible Locking Plates |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes
2.0 mm Craniofacial Locking Plates are substantially equivalent
to the predicate devices. |
| Device description: | Synthes 2.0 mm Craniofacial Locking Plates provide a locking
screw/plate interface. The plates contain threaded holes which
allow the use of 2.0 mm Locking screws, 2.0 mm Cortex screws
and 2.4 mm Emergency screws. |
| Material: | CP Titanium |
1
Image /page/1/Picture/1 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 a stylized image of three human profiles facing to the right, with three wavy lines above them. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K033065
Trade/Device Name: 2.0 mm Craniofacial Locking Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON, JEY Dated: September 26, 2003 Received: September 29, 2003
Dear Ms. Smith:
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 vour 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. Smith
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 (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.
Ques
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
3
Indications for Use Statement 2.
Page ____________ of _________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:
2.0 mm Craniofacial Locking Plates
Indications for Use:
Synthes 2.0 mm Craniofacial Locking Plates are indicated for selective trauma of the midface and craniofacial skeleton; craniofacial surgery, reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |
| (Division Sign-Off) | Rei Muly for MSR |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| Premarket Notification 510(k) Synthes 2.0 mm Craniofacial Locking Plates 510(k) Number: | K033065 |
000004