(81 days)
Not Found
No
The 510(k) summary describes a mechanical fixation system and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No.
The device is described as a fixation system (plates and screws) used in oral and maxillofacial surgery for various purposes, including trauma and reconstructive surgery, which are structural and mechanical interventions rather than therapeutic.
No
Explanation: The provided text describes a fixation system used for surgical procedures and lists its intended uses in various types of oral and maxillofacial surgery. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a system of physical plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in oral and maxillofacial surgery for procedures like trauma, surgical correction, and reconstructive surgery. This involves direct surgical intervention on the patient's body.
- Device Description: The description details a physical implant (plates and screws) used to fix bone. This is a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings for testing biological samples.
Therefore, the Synthes Mandibular Modular Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes 2.0 mm Sagittal Split Plates are intended for use in oral, maxillofacial surgery, such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic; and craniofacial surgery.
Product codes
JEY
Device Description
Synthes 2.0 mm Sagittal Split Plates have a curved design with six or eight static holes, are 1.25 mm thick, 24 mm - 29 mm in length, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm self-tapping screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
| Attachment VI: | Summary of Safety and Effectiveness Information
[510(k) Summary] |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
| | Contact: Sheri L. Musgnung |
| COMMON OR USUAL
NAME | Screw, Fixation, Intraosseous;
Bone Plate |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 872.4880 and 872.4760 |
| PREDICATE DEVICE: | Synthes Mandibular Modular Fixation System (K954385) |
| DESCRIPTION: | Synthes 2.0 mm Sagittal Split Plates have a curved design with
six or eight static holes, are 1.25 mm thick, 24 mm - 29 mm in
length, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm self-
tapping screws. |
| INTENDED USE: | Synthes 2.0 mm Sagittal Split Plates are intended for use in oral,
maxillofacial surgery, such as: trauma; surgical correction of
dentofacial deformities; reconstructive surgery; orthognathic;
and craniofacial surgery. |
| MATERIAL: | Titanium |
CONFIDENTIAL
ﺮ
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
K981890 Re : Synthes® (USA) Synthes MMFS - 2.0 mm Trade Name: Sagittal Split Plates Regulatory Class: II Product Code: JEY Dated: May 28, 1998 May 29, 1998 Received:
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions " The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Ms. Musgnung
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/3 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.
Attachment A: Revised Indications For Use Statement:
2.0 Indications for Use Statement
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K981890 |
| Device Name: | Synthes (USA) Mandibular Modular Fixation System Modification II |
| Indications For Use: |
The Synthes Mandibular Modular Fixation System is intended for use in oral, maxillofacial surgery, such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic surgery; and craniofacial surgery.
(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) OR
Over-The-Counter Use _
Siva Kumar
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number