(79 days)
Not Found
Not Found
No
The summary describes a system of plates, screws, and meshes for surgical fixation, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is an implantable system used for skeletal fixation in reconstructive and trauma surgeries, not for treating or rehabilitating a disease or medical condition.
No
The device description indicates it is a system of plates, burr hole covers, and meshes for skeletal reconstruction and fixation, not for diagnosing conditions. It is used during surgical procedures to treat anatomical issues.
No
The device description explicitly states it consists of physical components (plates, burr hole covers, meshes, screws, screwdriver blades) made of titanium or titanium alloy.
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 description details plates, screws, burr hole covers, and meshes made of titanium. These are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support and fixation.
N/A
Intended Use / Indications for Use
Synthes Neuro 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
JEY
Device Description
Synthes Neuro Plate and Screw System consists of plates, burr hole covers, 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)
Not Found (The K number is not provided in text. Only the trade name)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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 registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.
NOV 1 8 2004
3.0 510(k) Summary
| | Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Name: | Synthes (USA) Neuro Plate and Screw System |
| | Classification: | Class II, 21 CFR §872.4760
Bone plate |
| | | Class II, 21 CFR §882.5250
Burr hole cover |
| | | Class II, 21 CFR §872.4880
Intraosseous fixation screw or wire |
| | Predicate Device: | Synthes Midfacial System
Synthes Maxillofacial Titanium Micro Set
Synthes 1.5 mm Self-tapping cortex screws |
| | Device Description: | Synthes Neuro Plate and Screw System consists of plates, burr hole
covers, 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 Neuro 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
Neuro Plate and Screw System is substantially equivalent to other
legally marketed devices. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301
Re: K042365
Trade/Device Name: Synthes (USA) Neuro Plate and Screw System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 30, 2004 Received: August 31, 2004
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 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. 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/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
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a human figure inside of a circle. There is a horizontal line underneath the word and logo. To the right of the word is a registered trademark symbol.
Indications for Use
| 510(k) Number (if known): | K042365 |
|---|---|
| Device Name: | Synthes (USA) Neuro Plate and Screw System |
| Indications: | Synthes Neuro 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)
Kari Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
000004