(64 days)
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.
The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a 510(k) premarket notification summary and a clearance letter for the "FEP and Stylo" external fixation systems. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, design, and materials, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information from the given text.
To address your request, the document would need to include sections detailing:
- Specific performance objectives for the device (e.g., strength, durability, biocompatibility).
- Test methods used to evaluate these objectives.
- Results of such tests compared against predefined acceptance criteria.
- Details about any clinical or technical studies conducted (sample sizes, ground truth establishment, expert qualifications, etc.).
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OCT - 9 2003
0 32427
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MERIDIAN MEDICA
610 Newport Center Drive, Suite 1050 Newport Beach, CA 92660
SUMMARY
Submitter's name: Meridian Medical Address: 610 Newport Center Drive, Suite 1050 Newport Beach, CA 92660 Phone: 949-718-9220 949-718-9234 Fax number: Name of contact person:
Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 greg@regulatoryspecialists.com
Date the summary was prepared: July 31, 2003
| Name of the device: | FEP and Stylo |
|---|---|
| Trade or proprietary name: | FEP and Stylo |
| Common or usual name: | External fixation systems |
| Classification name: | Invasive traction component (per 21 CFR section 888.3040) |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| FEP Predicate | ||
|---|---|---|
| K# | Device Name | Manufacturer |
| K952730 | Hoffman II External Fixation System Howmedica | |
| Stylo Predicate | ||
| K# | Device Name | Manufacturer |
| K831576 | Orthofix | Orthofix |
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Description of the device:
K0324d7
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The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.
Intended use of the device:
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.
Summary of the technological characteristics of our device compared to the predicate device:
As can be seen in the Comparison section, the Meridian Medical devices and the Howmedica devices have similar technological characteristics, the same design and materials and are equivalent.
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Image /page/2/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 that resembles an eagle or a stylized human figure with outstretched arms. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Meridian Medical c/o Mr. Greg Holland Regulatory Consultant to Meridian Medial Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, CA 92606
Re: K032427
Trade/Device Name: FEP and Stylo Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: August 4, 2003 Received: August 6, 2003
Dear Mr. Holland:
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. Isting 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 such 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); 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.
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Page 2 - Mr. Greg Holland
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ l_____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _
FEP and Stylo Device Name:____
Indications For Use:
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.