(87 days)
No
The document describes a system of bone plates and screws for fracture fixation, with no mention of AI or ML capabilities.
No
The device is a system of plates and screws used for fracture fixation, joint fusion, and reconstruction of small bones, which are structural and mechanical functions, not therapeutic.
No
Explanation: The device is a surgical implant system (plate and screw system) used for treating fractures and reconstructing small bones, not for diagnosing conditions.
No
The device description clearly states it consists of multiple plate families, screws, and instruments, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fixing bone fractures and performing reconstructive procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates, screws, and instruments used in surgery. These are physical implants and surgical tools, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic information, or any of the typical components or functions of an IVD.
This device falls under the category of a surgical implant or orthopedic device.
N/A
Intended Use / Indications for Use
The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
Product codes
HRS
Device Description
The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes.
Indicated Patient Age Range
adult and pediatric patients.
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
No clinical testing was required. Based on testing results and the comparisons provided, the EPIC Extremity Fracture Plate System is considered substantially equivalent to the EPIC Extremity Plate System (K153340) in material, construction, and performance characteristics.
Key Metrics
Not Found
Predicate Device(s)
EPIC Extremity Plate System (K153340)
Reference Device(s)
EPIC Small Staple (K163226)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2017
EPIC Extremity, LLC Randy Schlemmer Director of Product Development 120 Marguerite Drive, Ste 301 Cranberry Twp, Pennsylvania 16066
Re: K172441
Trade/Device Name: EPIC Extremity Fracture Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 9, 2017 Received: August 11, 2017
Dear Randy Schlemmer:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172441
Device Name EPIC Extremity Fracture Plate System
Indications for Use (Describe)
The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for EPIC Extremity. The word "EPIC" is written in large, bold, black letters. Below the word "EPIC" is a blue and gray swoosh design, and below that is the word "EXTREMITY" in smaller, white letters.
EPIC Extremity Fracture Plate System
Submitter Information
| Applicant: | EPIC Extremity, LLC |
|---|---|
| 120 Marguerite Dr., Ste 301 | |
| Cranberry Twp., PA 16066 |
- Contact Person: Randy Schlemmer EPIC Extremity, LLC 120 Marquerite Dr., Ste 301 Cranberry Twp., PA 16066 (574)248-0060
- August 9th 2017 Date Prepared:
- Name of Device: EPIC Extremity Fracture Plate System
- Bone Fixation Plate Common Name:
- Classification Name Single/Multiple component metallic bone fixation appliances and accessories (per 21 CFR 888.3030)-Class II
- Product Code/Panel: HRS/Orthopedics
- EPIC Extremity Plate System (K153340). Predicate Devices: EPIC Small Staple (K163226) Reference.
Intended Use:
The EPIC Extremity Fracture Plate System is indicated for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.
4
Image /page/4/Picture/1 description: The image shows the logo for EPIC Extremity. The word "EPIC" is written in large, bold, black letters. Below the word "EPIC" is the word "EXTREMITY" in smaller, white letters on a blue and gray swoosh.
EPIC Extremity Fracture Plate System
Device Description
The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.
The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).
Technological Characteristics
The EPIC Extremity Fracture Plate System has the same intended use as the predicate devices. The EPIC Extremity Fracture Plate System has similar indications for use as the predicate devices. The EPIC Extremity Fracture Plate System is manufactured from the same materials as the predicate devices.
Non-Clinical Performance Data Summary
1. ASTM F-543
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the EPIC Extremity Fracture Plate System is considered substantially equivalent to the EPIC Extremity Plate System (K153340) in material, construction, and performance characteristics.