(87 days)
Not Found
No
The 510(k) summary describes a system of plates and screws for orthopedic fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The description focuses on the physical components and their intended use in surgical procedures.
No.
The device is a system of plates and screws used for surgical fixation in various facial and cranial procedures, which are considered restorative or reconstructive rather than therapeutic in the sense of treating a disease or disorder.
No
The device description indicates it is a surgical implant (plates and screws) used for fixation of bones, not for diagnosing conditions.
No
The device description explicitly states it includes physical components like plates and screws, which are hardware.
No, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device consists of plates and screws intended to be implanted into bone for surgical procedures.
- Intended Use: The intended use is for surgical fixation of bones in the face and skull.
This device is an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and craniofacial skeleton; surgery; reconstructive procedures; craniofacial and selective orthognathic surgery of the maxilla and chin.
Product codes
DZL
Device Description
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm 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, craniofacial skeleton, maxilla, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
SYNTHES
APR 16 1998
Attachment VI:
Summary of Safety and Effectiveness Information
[510(k) Summary]
K
SUBMITTER
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Plate, Bone
1980199
Class II, 21 CFR 888.3030 and 872.4760
CLASSIFICATION:
PREDICATE DEVICE:
Synthes Midfacial System (K953806)
DESCRIPTION:
DEVICE
INTENDED USE:
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws.
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and craniofacial skeleton; surgery; reconstructive procedures; craniofacial and selective orthognathic surgery of the maxilla and chin.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 17 1998
Ms. Sheri L. Musqnung Regulatory Affairs Associates Synthes® (USA) 1690 Russell Road Post Office Box 1766 19301 Paoli, Pennsylvania
Re : K980199 Synthes® (USA) 1.5mm/2.0mm Orthognathic Trade Name: Maxillary Plates and Screws Requlatory Class: II Product Code: DZL January 19, 1998 Dated: Received: January 20, 1998
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 Register. 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 findinq 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 requlation (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) 638-2041g or (301) 443-6597 or at its internet address "http://www.fda.gpv/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
TES®
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
Page of
K980199 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Synthes (USA)1.5 mm / 2.0 mm Orthognathic Maxillary Plates Device Name: and Screws
Indications For Use:
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for 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 (Per 21 CFR 801.109) OR
Over-The-Counter Use
Herold W. Shapiro
(Division Sign-Off)
ental, Infection Control. and General Hospital 510(k) Number