OPUS MAGNUM ANCHOR WITH INSERTER

K041440 · Opus Medical, Inc. · MBI · Jun 25, 2004 · Orthopedic

Device Facts

• Record ID: K041440
• Device Name: OPUS MAGNUM ANCHOR WITH INSERTER
• Applicant: Opus Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

Device Story

The Opus Magnum® Anchor with Inserter is a bone fixation fastener used for soft tissue-to-bone attachment during rotator cuff repair. The system consists of an anchor and an inserter tool. The device modification introduces MagnumWire™, a braided polyester suture, as an optional component. The device is intended for use by surgeons in an operating room setting. The anchor is implanted into the bone to secure the soft tissue, facilitating repair. The addition of the new suture provides user convenience without altering the fundamental technology or intended use of the existing Opus Magnum® Implant System.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparison to the predicate device.

Technological Characteristics

Bone fixation fastener system. Materials include non-degradable components and braided polyester suture. The device functions as a mechanical anchor for soft tissue. No software or electronic components are involved.

Indications for Use

Indicated for rotator cuff repair in the shoulder.

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 Magnum® Implant Set (K041440)
• FiberWire® USP braided polyester suture (K031083)

Submission Summary (Full Text)

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Opus Medical, Inc.

K04/440

## SECTION 4: 510(k) SUMMARY

# JUN 2 5 2004

(Premarket Notification [510(k) Number]

| Manufacturer | Opus Medical, Inc.<br>27127 Calle Arroyo, Suite 1924<br>San Juan Capistrano, CA 92675 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Laura Kasperowicz, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | May 28, 2004 |

## Device Information

| Trade Name: | Opus Magnum® Anchor with Inserter |
|----------------------|-------------------------------------------------|
| Common Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Classification: | Class II per 21 CFR 888.3040; Product Code: HTY |

#### Substantial Equivalence

The Opus Magnum® Anchor with Inserter is substantially equivalent to the existing Opus Magnum® Implant Set cleared by the Food and Drug Administration. The intended use of the Opus Magnum® Anchor with Inserter is substantially equivalent to the intended use of the existing Opus Magnum® Implant Set, for fixation of soft tissue to bone.

#### Indications For Use

The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

## Device Description and Reason for 510(k) Notification

The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.

JUN 2 5 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675

Re: K041440

Trade/Device Name: Opus Magnum® Anchor with Inserter Regulation Number: 21 CFR 888.3040, 21 CFR 878.5000 Regulation Name: Metallic bone fixation fastener, Nonabsorbable polyethylene surgical suture Regulatory Class: II Product Code: MBI, GAT Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Kasperowicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premised is substantially equivalent (for the indications ferenced above and nave decemined the arredicate devices marketed in interstate for tise stated in the encrosule) to tegally manatise province Americal Device Amendments, or to commerce province way 26, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). allu Cosmetic Act (Act) that do not requence appent of the general controls provisions of the Act. The You may, merclove, market me device, excirements for annual registration, listing of general controls provisions of the fies 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 If your device is classified (500 abor of the Existing major regulations affecting your device can may be subject to such additional econsolors, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean FICASE oc advised that i DFF 3 localites over device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I cuttar statutes and regarations and admited to: registration and listing (21 comply with an the Act 3 requirements, merchang, and manufacturing practice requirements as set Crit Fatt 807), labeling (21 CFR Part 800); goods ionin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Laura Kasperowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket nothleadon: "The PDA mailing of basion 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 If you desire specific acvice for your as 1) 594-4659. Also, please note the regulation entitled, comact the Office of Comphanes at (so t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Obless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

iriam l. Provost

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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Opus Medical, Inc.

510(k) Notification

Opus Magnum® Bone Anchor with Inserter Page 8 of 31

SECTION 3: STATEMENT OF INDICATIONS FOR USE

K041440

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Opus Magnum® Bone Anchor with Inserter

Indications for Use:

The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.

Prescription Use X (Per CFR 801.109)

OR

Over-The-Counter Use -------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________