OPUS MAGNUM ANCHOR & INSERTER

K012125 · Opus Medical, Inc. · HTY · Sep 17, 2001 · Orthopedic

Device Facts

• Record ID: K012125
• Device Name: OPUS MAGNUM ANCHOR & INSERTER
• Applicant: Opus Medical, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Sep 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

The Opus Magnum Anchor and Inserter is a surgical instrument system used by orthopedic surgeons for soft tissue-to-bone fixation during shoulder rotator cuff repair. The device consists of an anchor and an associated inserter tool. The surgeon uses the inserter to place the anchor into the bone, providing a secure attachment point for soft tissue. The system facilitates the mechanical reattachment of torn rotator cuff tendons to the humeral head. It is intended for use in a clinical or operating room setting.

Clinical Evidence

no clinical data

Technological Characteristics

Surgical anchor and inserter system for soft tissue-to-bone fixation. Mechanical device; no energy source or software components.

Indications for Use

Indicated for fixation of soft tissue to bone in shoulder rotator cuff repair procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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):

K012125

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