(89 days)
Not Found
No
The description focuses on the mechanical components of a plate and screw system for surgical fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a system of plates and screws used for oral and maxillofacial surgery, primarily for trauma, reconstructive surgery, and orthognathic surgery. It is a fixation device, not a therapeutic device designed to cure or prevent diseases.
No
The device description indicates it is a locking plate system with screws, intended for oral and maxillofacial surgery (trauma, reconstructive, orthognathic surgery). This describes a surgical implant system, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components (plates and screws) and their mechanical interaction, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for oral and maxillofacial surgery, involving trauma, reconstructive surgery, and orthognathic surgery. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a system of plates and screws designed for internal fixation of bone. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Synthes 2.0 LPS is a surgical implant used for bone fixation during oral and maxillofacial procedures.
N/A
Intended Use / Indications for Use
The Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Product codes
JEY
Device Description
The 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and L-), and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, maxillofacial
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.
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Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, black letters. There is a trademark symbol to the right of the word "SYNTHES".
974555
Summary of Safety and Effectiveness Information [510(k) Summary]
MAR - 3 1998 Synthes (USA) SPONSOR 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri Bone Plate and Bone Screw COMMON OR USUAL NAME Class II, 21 CFR 872.4760 and 872.4880 DEVICE CLASSIFICATION Synthes Mandibular Modular Fixation System (K954385), Synthes PREDICATE DEVICE 2.4 mm Universal Locking Plate System (K961421), and SMF Ti Alloy Bone Screws (K963546) The 2.0 Locking Plate System consists of five different types of DESCRIPTION plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 的 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and L-), and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system. The Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; INTENDED USE reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). MATERIAL The plates are manufactured from CP Titanium and Ti-15Mo, and the screws are manufactured from titanium alloy (Ti-6Al-7Nb).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1998
Ms. Angela J. Silvesti Manager, Regulatory Affairs Synthes (USA) 1101 Synthes Avenue Monument, Colorado 80132
K974555 Re : Synthes 2.0mm Locking Plate System (2.0 LPS) Trade Name: Regulatory Class: II Product Code: JEY December 3, 1997 Dated: December 4, 1997 Received:
Dear Ms. Silvesti:
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, 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. A substantially equivalent determination assumes compliance with ..... the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
2
Page 2 - Ms. Silvesti
through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your mavice 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) 594-4618. 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,
Patricia Cusinatt/hor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital 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 circular logo with a stylized figure inside. The logo and the word "SYNTHES" appear to be the brand name of a company. The overall image has a clean and professional look.
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
Page 1 of 1
510(k) Number (if known):
Synthes (USA) 2.0 Locking Plate System Device Name:
Indications for use:
The Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off)
Division of Dental, Infectioratrol,
and General Hospital Devices
510(k) Number. K974335
escription Use OR Over-The-Counter Use
Prescription Use V (Per 21 CFR 801.109)
OH
Over-The-Counter Use __