(133 days)
Omnitech System: The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.
EasyLock Osteosystem & Xtremities: The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.
Not Found
The provided text is a 510(k) summary for medical devices (Omnitech and Easy Lock Osteosystem). It describes the intended use and establishes substantial equivalence to predicate devices. It does not contain information on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory submission and equivalence, not on performance study details.
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510(K) Summary of Safety and Effectiveness OMNITECH and EASY LOCK OSTEOSYSTEM
| Submitted By: | TriMed, Inc.25768 Parada DriveValencia, CA 91355(800)633-7221 |
|---|---|
| Registration #: | 2031009 |
| Manufactured By: | Biotech International305, Allées de Craponne13300 Salon de Provence, FrancePhone: (33)4 90 44 60 60Fax: (33)4 90 44 60 61 |
| Manufacturer's Registration #: | K050681 |
| Prepared By/Contact Person: | Kelli AndersonPhone: (661) 312-7150Fax: (661) 254-8485 |
| Proprietary Name: | OmnitechEasy Lock Osteosystem withXtremities Plates |
| Classification: | Class II: Plate Fixation BoneSection 888.3030Screw Fixation BoneSection 888.3040 |
| Classification Code: | HRSHWC |
| Summary Preparation Date: | June 3, 2005 |
Intended Use:
Omnitech System:
The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.
EasyLock Osteosystem & Xtremities:
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The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.
Substantial Equivalence:
Omnitech
K991964 - Lepine EIS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - Howmedica Profyle Hand & Small Fragment System
Easy Lock
K021626 - Newdeal Hallu Plates K961941 - Howmedica Profyle Hand & Small Fragment System (Now Stryker Leibinger) K991873 – KMI Wrist Fusion System K021321 - Acumed Wrist Fusion Plate
Luci Anderson
Kelli Anderson Regulatory Affairs Specialist
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health.
JUL 8 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kelli Anderson Regulatory Affairs Specialist TriMed, Inc. 25768 Parada Drive Valencia, California 91355
Re: K050681
Trade/Device Name: Omnitech® System EasyLock Osteosystem & Xtremities Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: June 7, 2005 Received: June 9, 2005
Dear Ms. Anderson:
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 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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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 (240) 276-0120. 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,
Hypt Rhodes
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050681
Omnitech® System Device Name: EasyLock Osteosystem & Xtremities
Indications For Use
Omnitech System:
The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.
EasyLock Osteosystem & Xtremities:
The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.
Prescription Use 7 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyt Durdis
Division of General, Restorative, and Neurological Devices
510(k) Number K050681
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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.