(90 days)
Not Found
Not Found
No
The summary describes a mechanical implant system (plates and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
This device is for internal fixation of bones, which is a structural and mechanical function, not a therapeutic one in the sense of treating a disease or disorder. Its purpose is to stabilize bone fractures to facilitate healing, rather than actively administering treatment.
No
The device is described as an internal fixation system for bones, indicating a therapeutic or supportive function rather than diagnosing a condition.
No
The device description explicitly states it consists of "disposable locking plates and screws," which are physical hardware components, not software.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The DeRoyal non-sterile locking compression plate system is a surgical implant used for internal fixation of bones. It is physically placed inside the body to stabilize fractures or other bone issues.
- Intended Use: The intended use is for internal fixation of bones, which is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, this device clearly falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DeRoyal Non-Sterile Locking Compression Plate System is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.
Product codes
HRS, HWC
Device Description
The DeRoyal Non-Sterile Locking Compression Plate System consists of disposable locking plates and screws in either stainless steel or titanium. The plates have alternating holes to accept either cortical, malleolar, shaft, cancellous or locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
A092317
Page 1 of 1
510(k) Summary
NOV - 2 2009
SPONSOR:
DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849
System
HRS
DEVICE NAME:
CLASSIFICATION NAME:
Class II, 21CFR888.3030 - Single/multiple component metallic bone fixation appliances and accessories.
DeRoyal Non-Sterile Locking Compression Plate
PRODUCT CODE:
PREDICATE DEVICE:
Synthes Locking Compression Plates (LCP) Synthes Locking Screws
DEVICE DESCRIPTION:
The DeRoyal Non-Sterile Locking Compression Plate System consists of disposable locking plates and screws in either stainless steel or titanium. The plates have alternating holes to accept either cortical, malleolar, shaft, cancellous or locking screws.
INTENDED USE: The DeRoyal Non-Sterile Locking Compression Plate System is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.
SUBSTANTIAL
EQUIVALENCE: Information presented supports substantial equivalence.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV 0 2 2009
DeRoyal Industries, Inc. % Ms. Gracie Greenway Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K092317
Trade Name: DeRoyal Locking Compression Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: HRS, HWC Dated: July 27, 2009
Received: August 4, 2009
Dear Ms. Greenway:
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.
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.
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
2
Page 2 - Ms. Gracie Greenway
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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number:
9231
Device Name: DeRoyal Industries, Inc. Locking Compression Plate System
The DeRoyal non-sterile locking compression plate system is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.
Prescription Use __ X (Per 21CFR 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millerson
(Division Sign-Off) (Division of Surgical, Orihopedic, and Restorative Devices
510(k) Number
KO92317