(69 days)
The Opus Magnum Implant is intended for fixation of tendon to bone using a "silky" II Polydek® non-absorbable braided polyester or FiberWire® braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement.
Indications:
(1) Shoulder 1) Rotator Cuff Repair
The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation.
This document is a 510(k) clearance letter from the FDA for the Opus Magnum™ Implant System. It does not contain any information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, or study methodologies (like MRMC or standalone performance studies).
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. There is no performance data, clinical study information, or details of a study proving the device meets acceptance criteria provided in this document.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2003
Mr. James W. Hart President/CEO Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675
K031083 Re:
Trade Name: Opus Magnum™ Implant System - Model Number OM-1500 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY and MBI Dated: April 3, 2003 Received: April 30, 2003
Dear Mr. Hart:
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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Page 2- Mr. James W. Hart
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,
R. Mark N. Milliken
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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Magnum TM Implant System
KO31083 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Magnum™ Implant System Device Name:
Indications for Use:
Magnum Implant System:
The Opus Magnum Implant is intended for fixation of tendon to bone using a "silky" II Polydek® non-absorbable braided polyester or FiberWire® braided polyblend USP size #2 suture for the indications listed below. The Magnum system consists of a fixation device pre-loaded with suture snares in an inserter handle. The Magnum Implant is a knotless fixation device whereby surgical knots are not necessary for fixation. Bone stock must be adequate to allow proper placement.
Indications:
(1) Shoulder 1) Rotator Cuff Repair
Mark N. Millican
Division of General, Restorative and Neurological Devices
KO3 1083 510(k) Number_
(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 ____________
§ 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.