(41 days)
The provided text does not contain any K/DEN numbers for predicate devices. It states: "Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices." but does not list specific K/DEN numbers.
Empty.
No
The summary describes titanium plates for surgical procedures and does not mention any AI or ML components or functionalities.
No
The device is a medical implant used for reconstructive and surgical purposes, not directly for therapeutic treatment (e.g., drug delivery, radiation therapy, active disease treatment).
No.
The Synthes Cranial Plates are described as titanium plates used for surgical reconstruction and repair of the craniofacial skeleton, not for identifying the presence, nature, or absence of a disease or condition.
No
The device description clearly states the device is "titanium plates," which are physical hardware components, not software.
Based on the provided information, the Synthes Cranial Plates are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the plates are for surgical procedures involving the midface and craniofacial skeleton. This is a direct surgical intervention on the body.
- Device Description: The description confirms they are titanium plates used in surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Synthes Cranial Plates are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Cranial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; and orthognathic surgery of the maxilla and chin.
Product codes
JEY, GXR
Device Description
The Synthes Cranial Plates are titanium plates in a variety of shapes for various cranio-facial procedures.
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)
Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices.
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
FEB 2 0 2002
Summary of Safety and Effectiveness Information 3.
Ko20087
Sponsor
Company Contact
Name of the Device
Device Classification(s)
Substantial Equivalence
Device Description
Indications
Material
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Matthew M. Hull (610) 647-9700 ext. 7191
Synthes Cranial Plates
Class II, §872.4760 - Plate, Fixation, Bone Class II, §882.5250 - Burr Hole Cover
Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices.
The Synthes Cranial Plates are titanium plates in a variety of shapes The Synanes Crand for various cranio-facial procedures.
The Synthes Cranial Plates are intended for use in selective trauma of The ByInthos Craniofacial skeleton; craniofacial surgery; the initiface and craineral in is selective orthognathic surgery of the maxilla and chin
Titanium
Synthes(USA) Synthes Cranial Plates 510(k) CONFIDENTIAL
000005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K020087
Trade/Device Name: Synthes Cranial Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and GXR Dated: January 07, 2002 Received: January 10, 2002
Dear Mr. Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Secuon 710(x) personalially equivalent (for the referenced above and have attermined to legally marketed predicate devices marketed in
indications for use stated in the enclosure , to legally marketed in
the enclose for us indications for use stated in the cholosator , to he enactment date of the Medical Device interstate commerce prior to reay 20, 1770, and enified in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approvel of a Amendments, or to devices that nave been rocal require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires, subject to the general the Federal Food, Drug, and Cosment / col (recore, market the device, subject to the general
approval application (PMA). You may, therefore, market the Act include approval application (1 MA). "Tou may) and controls provisions of the Act include controls provisions or the Act. The genting of devices, good manufacturing practice, requirements for annical rogginst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) incolors. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Time 21, Rests 800 to 898 (PMA), it may be subject to Such additional concern Regulations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Register i your device can be found in the Code of Pecelar regionerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualles of a substance of the requirements
mean that FDA has made a determination that your device complies with organizes mean that FDA has made a decemination untily of the Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Mr. Matthew M. Hull
You must comply with all the Act's requirements, including, but not limited to: registration
ing and the many of the line (0) - GED Port Roll); good manufacturing practice You must comply with all the Act s'requirence.se increating oud manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labellity (21 CF PC PC PC Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QB) regulation (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 This letter will allow you to begin marketing your covistantial equivalence of your device to
510(k) premarket notification. The FDA finding of sourcevice and thus, 510(k) premarket notification. The PDA finantig or casestion for your device and thus, a legally mur device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801
) and the If you desire specific advice for your device in vitro diagnostic devices), please contact the and additionally 21 CFR Part 809.10 for in valid the donestions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Compliance at (301) 594-4015. "Italifone of Compliance at (301) 594-4639.
advertising of your device, please contact the Office has been programs to premarket advertising of your device, picase consisted, "Misbranding by reference to premarket. Also, please note the regulation entitled, "Internation on your responsibilities under
notification" (21CFR Part 807.97). Other general information on your responsibilities notification" (21CFR Part 807.97). Unier general Manufacturers, International and the Act may be obtained from the Division of Only 638-2041 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (80) was an html Consumer Assistance at its ton nov fodrh/dsma/dsmamain.html
Sincerely yours,
Patrea Cinciniffe
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
Indications for Use Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes Cranial Plates
The Synthes Cranial Plates are intended for use in I he Synthes Crainal I lawdface and craniofacial is selective trauma of the mirala"; reconstructive skeleton; cramoracial surgery, orthognathic surgery of the maxilla and chin.
020087
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONFIDENTIAL
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
000004
| Division Sign-Off | Phamida D. Sood for Swann H |
|---|---|
| Dental Infection Control, | |
| ral Devices | |
| KC20087 |