(375 days)
Not Found
No
The device description focuses on the materials and mechanical components of a plate and screw system for maxillofacial surgery, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a fixation system used for repairing maxillofacial fractures and reconstruction, which is a structural and supportive function, not a therapeutic one that treats or cures a disease.
No
The device is described as a plate and screw system for rigid fixation in the repair of maxillofacial fractures and reconstruction. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a plate and screw system made of titanium and stainless steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Porex Fixation System is a system of plates and screws made of titanium and stainless steel. These are physical implants used to fix bones.
- Intended Use: The intended use is for "rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device is a surgical implant, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The Porex Fixation System is a plate and screw system to be used in maxillofacial surgery and is provided in various configurations. The components that comprise the systems are composed of unalloyed titanium plates, titanium alloy bone screws and surgical stainless steel instruments for the installation of the screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 standard. The screws are manufactured of 6-4 ELI titanium that meets the A.S.T.M F136 standard. The screws are provided in 1.5mm diameter and 4mm length. The rescue screws are green color annodized and provided in 1.8mm diameter and 4mm length. The Porex Fixation Systems are sterilized by ethylene oxide sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
POREX
SURGICAL PRODUCTS GROUP
JUN 2 8 2010
2
510(k) SUMMARY
Date of Summary: June 21, 2010
Manufacturer and Submitter:
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: (678) 479-1610 Fax: (678) 479-4495
Contact: Stephanie Fullard E-mail: stephanie.fullard@porex.com
Trade Name: Porex Fixation System for Maxillofacial Surgery
Common Name: Plates and Screws
Class: II, 21 CFR 872.4760 - Plate, Fixation, Bone II, 21 CFR 872.4880 - Screw, Fixation, Intraosseous
Product Code: JEY Subsequent Product Code: DZL
Substantially equivalent to:
-
- Synthes (USA) Synthes Craniofacial Plates K021642
-
- Synthes (USA) SMF Ti Alloy Bone Screws K963546
-
- Stryker Leibenger Universal CMF System K022185
ર - I
1
Image /page/1/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The logo is in black and white, with the word "POREX" in large, bold letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
Device Description:
The Porex Fixation System is a plate and screw system to be used in maxillofacial surgery and is provided in various configurations. The components that comprise the systems are composed of unalloyed titanium plates, titanium alloy bone screws and surgical stainless steel instruments for the installation of the screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 standard. The screws are manufactured of 6-4 ELI titanium that meets the A.S.T.M F136 standard. The screws are provided in 1.5mm diameter and 4mm length. The rescue screws are green color annodized and provided in 1.8mm diameter and 4mm length. The Porex Fixation Systems are sterilized by ethylene oxide sterilization.
Indications for Use:
The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System for maxillofacial surgery is intended for single use.
Technological Characteristics:
The Porex Fixation System has the same intended use and is manufactured from substantially the same materials as the predicate devices. The technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences raise no new issues of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three overlapping lines forming the body and head.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Stephanie Fullard, RAC Regulatory Affairs Manager Porex Surgical, Incorporated 15 Dart Road Newman, Georgia 30265
JUN 2 8 2010
Re: K091807
Trade/Device Name: Porex Fixation System For Maxillofacial Surgery Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 21, 2010 Received: June 23, 2010
Dear Ms. Fullard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Ms. Fullard
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nfor
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K091807
Device Name: Porex Fixation System For Maxillofacial Surgery
Indications for Use: The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Anesthesiology, General HospitalPage 1 of 1 Infection Control, Dental Devices
510(k) Number: Ko 9 1807