OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)

K081497 · Arthrocare Corp. · MBI · Jul 28, 2008 · Orthopedic

Device Facts

• Record ID: K081497
• Device Name: OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
• Applicant: Arthrocare Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opus Magnum X device is a bone anchor system with inserter that is indicated for use in fixation of soft tissue to bone for rotator cuff repair.

Device Story

Opus Magnum X is a bone anchor system with an inserter handle used in arthroscopic and orthopedic procedures. It facilitates the fixation of soft tissue to bone, specifically for rotator cuff repair. The device is operated by a surgeon in a clinical or surgical setting. It functions as a mechanical fastener to secure tissue, providing stability during the healing process. The system is a modification of the predicate Opus Magnum2 device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Bone anchor system with inserter handle. Materials are well-characterized and consistent with predicate devices. Mechanical fixation device.

Indications for Use

Indicated for fixation of soft tissue to bone for rotator cuff repair in patients requiring such orthopedic intervention.

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 Magnum2 (K042914)

Submission Summary (Full Text)

{0}------------------------------------------------

K081497 # 1/2

## 510(K) SUMMARY

ARTHROCARE CORPORATION OPUS MAGNUM X KNOTLESS FIXATION DEVICE

## General Information

JUL 2 8 2008

| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-3523 |
|---------------------------------|------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 2951580 |
| Contact Person: | Laura N. Kasperowicz<br>Sr. Manager, Regulatory Affairs |
| Date Prepared: | May 28, 2008 |
| Device Description | |
| Trade Name: | Opus Magnum® Knotless Fixation Device |
| Device Model Name: | Opus Magnum® X Knotless Fixation Device |
| Generic/Common Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Nondegradeable, Soft Tissue<br>(Class II per 21 CFR 888.3040, Product code: MBL) |
| Predicate Devices | Opus Magnum2<br>K042914 (Cleared 11/12/2004) |

### Product Description

The Opus Magnum X device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.

### Indications For Use

The Opus Magnum X device is a bone anchor system with inserter that is indicated for use in fixation of soft tissue to bone for rotator cuff repair

{1}------------------------------------------------

K08149) # 2/2

## 510(K) SUMMARY

#### Substantial Equivalence

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus Magnum X design and technology is substantially equivalent to the existing Opus Magnum2 Knotless Fixation Device cleared by the Food & Drug Administration [K042914]. The differences between the Opus Magnum X and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.

### Summary and Reason for 510k Notification

The purpose of this 510k is to notify the Food and Drug Administration of a proposed modification to an existing product. The proposed device, the Opus Magnum X Knotless Fixation Device is substantially equivalent to the Opus Magnum2 Knotless Fixation Device originally cleared under K042914.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 8 2008

Arthrocare Corp. % Ms. Laura N. Kasperowicz 15285 Alton Parkway, #200 Irvine, CA 92618

Re: K081497

> Trade/Device Name: Opus Magnum X Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: MBI Dated: June 26, 2006 Received: June 30, 2008

Dear Ms. Kasperwicz:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Laura N. Kasperwicz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

ко 81497 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number: Device Name: Opus Magnum X Knotless Fixation Device Indications for Use: The Opus Magnum X bone anchor with inserter is indicated for use in fixation of soft tissue to bone for rotator cuff repair. NO Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nl

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

510(k) Number L041994