(90 days)
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Not Found
No
The device description focuses solely on the mechanical components (plates and screws) for bone fixation and makes no mention of AI or ML technology.
Yes.
The device is intended for the internal fixation of long bone fractures and long bone reconstruction, which are therapeutic interventions.
No
Explanation: The device is an internal fixation system for long bone fractures, consisting of plates and screws, which is a therapeutic device rather than a diagnostic one.
No
The device description explicitly details physical components such as plates and screws, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation of long bone fractures and long bone reconstruction." This describes a surgical procedure performed directly on the patient's body to stabilize bones.
- Device Description: The description details plates and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not perform any such analysis of specimens.
The EPI-Union Plating System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HRS and HWC
Device Description
The Epi-Union Plating System consists of a series of plates and screws for the internal fixation of long bone fractures and long bone reconstruction. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation. The different styles of plates are precontoured to fit the anatomical profile of each specific site. The system includes tibial plates, fibular plates, calcaneal plates, humeral plates, and radial plates.
The system includes cancellous and cortical screws with head diameters of 6mm and 8mm. The screws are available in thread diameters ranging from 3.5mm to 6.5mm in varying lengths. Different styles include self-tapping, non-self-tapping, fully threaded, and partially threaded screw designs. The plates can also be used with standard cortical or cancellous bone screws that are commercially distributed.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
long bone fractures and long bone reconstruction. Specific sites mentioned include tibial, fibular, calcaneal, humeral, and radial.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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
510(k) Summary
FEB | 2 |998
Device:
Epi-Union Plating System
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 (201) 507-7830 Fax: (201) 507-6870
The Epi-Union Plating System consists of a series of plates and screws for the internal fixation of long bone fractures and long bone reconstruction. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation. The different styles of plates are precontoured to fit the anatomical profile of each specific site. The system includes tibial plates, fibular plates, calcaneal plates, humeral plates, and radial plates.
The system includes cancellous and cortical screws with head diameters of 6mm and 8mm. The screws are available in thread diameters ranging from 3.5mm to 6.5mm in varying lengths. Different styles include self-tapping, non-self-tapping, fully threaded, and partially threaded screw designs. The plates can also be used with standard cortical or cancellous bone screws that are commercially distributed.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices used for internal fixation of long bones. These devices include Synthes' ASIF® Implants, the Dupont Distal Humeral Plate System and BG Compression System distributed by Howmedica Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, and it is used on a variety of government documents and websites.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1998
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica, Inc. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K974289 EPI-UNION Plating System Regulatory Class: II Product Code: HRS and HWC November 14, 1997 Dated: Received: November 14, 1997
Dear Ms. Kelly:
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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of -------This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to Accordinqly: marketinq.
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
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Page 2 - Ms. Vivian Kelly
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under Part 812. All users of the device for pedicular 21 CFR, screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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 Regulations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Ms. Vivian Kelly
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4659. 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 --------Other general premarket notification" (21 CFR 807.97). 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,
[signature]
Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K974289
Device Name: EPI-UNION™ PLATING SYSTEM
Indications for Use:
The EPI-Union Plating System is intended for use in the internal fixation of long bone fractures and long bone reconstruction.
Prescription Use
(Per 21 CFR 801.109)
fucello
(Divisio Divisio 510(k) Nur