OPUS MAGNUM ANCHOR & INSTRUMENT SET

K020172 · Opus Medical, Inc. · MBI · Jul 22, 2002 · Orthopedic

Device Facts

• Record ID: K020172
• Device Name: OPUS MAGNUM ANCHOR & INSTRUMENT SET
• Applicant: Opus Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opus Magnum® Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications: - (1) SHOULDER 1.) Rotator Cuff Repair

Device Story

The Opus Magnum Instrument Set is a manual surgical tool used for soft tissue-to-bone fixation. It consists of an inserter squeeze handle with a stainless steel nosepiece. The device is used by surgeons in a clinical or operating room setting to facilitate rotator cuff repair. It functions as a mechanical instrument for anchor placement; it does not involve electronic inputs, software, or automated processing. The device is supplied non-sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument set; stainless steel nosepiece; squeeze handle inserter tool; non-sterile supply.

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.

Predicate Devices

• Opus Medical prior submission (K012125)

Submission Summary (Full Text)

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# JUL 2 2 2002

Summary of Safety and Effectiveness

K030172
page 1 of 1

## DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The claim of substantial equivalence is based upon Opus Medical's prior submission for the same device K012125.

#### COMPANY AND CONTACT PERSON

Opus Medical, Inc. 27127 Calle Arrovo. Suite 1924 San Juan Capistrano, CA 92675 Tel. [phone] FAX [phone]

Contact Person: Mr. Jim Hart Tel. [phone]

# DEVICE NAME

Opus Magnum® Instrument Set

# DESCRIPTION OF DEVICE

The Opus Magnum Instrument Set consists of an Inserter squeeze handle tool with a stainless steel nosepiece.

The Instrument Set is supplied non-sterile.

#### STATEMENT OF INTENDED USE

The Opus Magnum Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications:

- (II) SHOULDER 1.) Rotator Cuff Repair
# STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICE

The predicate device is used for fixation of soft tissue to bone for shoulder rotator cuff repair.

# STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

The Opus Magnum Instrument Set has the same technological characteristics as the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2002

Mr. Jim Hart Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675

Re: K020172 Trade/Device Name: Opus Magnum® Anchor & Instrument Set Regulatory Class: Unclassified Product Code: MBI Dated: April 18, 2002 Received: April 24, 2002

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. Jim 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. 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.

Mark A. Millmann

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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510(k) Number (if known): K Od Ol 7Q

Device Name: Opus Magnum® Anchor & Instrument Set

Indications For Use: The Opus Magnum® Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications:

- (1) SHOULDER 1.) Rotator Cuff Repair
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter Use

Mark N Milkman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number -

510 (k) Notification
Opus Medical

January 14, 2002