(73 days)
The Opus Magnum Anchor and Inserter is intended for the fixation of soft tissue to bone for the following indications: SHOULDER (l) 1.) Rotator Cuff Repair
Not Found
The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Opus Magnum Anchor and Inserter." This type of document declares that a device is substantially equivalent to a predicate device and can be marketed, but it does not contain information about acceptance criteria or specific study results showing the device meets those criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document. The document describes the regulatory approval process but does not include the detailed technical and clinical study data that would inform such criteria and performance reports.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2001
Mr. Mark Ritchart President and CEO Opus Medical, Inc. 27127 Calle Arroyo Suite 1924 San Juan Capistrano, California 92675
Re: K012125
Device Name: Opus Magnum Anchor and Inserter Regulation Number: 21 CFR 888.3040 Regulatory Class: Class II Product Codes: HTY and MBI Dated: July 3, 2001 Received: July 6, 2001
Dear Mr. Ritchart:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your boouen b x (=) = (= ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrate commerce prior to +1x) 20, 20, 20, 20, 2011 11:25 pm accordance with the provisions of the Antenditions of to devices that its t (Act). You may, therefore, market the device, subject to r cuclar 1 ood, Drug, and Ooshleav Lev (t. The general controls provisions of the Act include the general oonliness provinsible is in, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripproval), it they over the Code of Federal Regulations, Title 21, Parts 800 to 895. all substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through Fraction of Mourvalions, FDA will verify such assumptions. Failure to comply with the GMP periodic Grill in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements 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.
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Page 2 - Mr. Mark Ritchart
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4639 . Additionally, for questions on 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Walker, MD
Image /page/1/Picture/4 description: The image shows a black and white drawing of a symbol. The symbol is abstract and appears to be a stylized letter or character. It has a curved shape with a small tail-like extension on the right side. The symbol is simple and minimalist in design.
Celia Witten, M.D, Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name: Opus Magnum® Anchor & Inserter
Indications For Use: The Opus Magnum Anchor and Inserter is intended for the fixation of soft tissue to bone for the following indications:
SHOULDER (l) 1.) Rotator Cuff Repair
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Per 21 CFR 801.109
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
SL
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number #K012125
§ 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.