OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500

K081893 · Arthrocare Corp. · HWC · Oct 1, 2008 · Orthopedic

Device Facts

• Record ID: K081893
• Device Name: OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
• Applicant: Arthrocare Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opus Magnum SpeedScrew bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Story

Opus Magnum SpeedScrew is a knotless bone anchor system with an inserter handle; used in arthroscopic and orthopedic procedures to secure soft tissue to bone. Device functions as a mechanical fixation fastener. Operated by surgeons in clinical/OR settings. Provides secure tissue attachment without requiring manual knot tying, potentially reducing procedure time and improving fixation reliability. Benefits include stable soft tissue-to-bone reattachment for various joint repairs.

Clinical Evidence

No clinical data provided; substantial equivalence 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 principle. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for fixation of soft tissue to bone in orthopedic procedures including shoulder (Bankart, SLAP, rotator cuff, biceps tenodesis, deltoid repair), ankle (instability, Achilles, midfoot), foot (hallux valgus), elbow (tennis elbow, biceps attachment), and knee (extra-capsular repairs, ligament/tendon reattachment).

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 PI (K070227)
• Arthrex PEEK SwiveLock (K061863)

Submission Summary (Full Text)

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K08189}

## 510(K) SUMMARY

ARTHROCARE CORPORATION OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE

## General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration No .: 2951580

Contact Person:

Laura N. Kasperowicz Sr. Manager, Regulatory Affairs

Date Prepared:

July 2, 2008

#### Device Description

Trade Name:

Opus Magnum SpecdScrcw™ Knotless Fixation Device

Generic/Common Name:

Classification Name:

Fixation Point

Bonc Anchor

Screw, Fixation, Bone (Class II per 21 CFR 888.3040, Product code: HWC)

#### Predicate Devices K070227 (Cleared 04/16/07) Opus Magnum PI Arthrex PEEK SwiveLock K061863 (Clcared 10/19/06)

## Product Description

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

### Indications For Use

The Opus® SpeedScrew™ device is a bonc anchor system with inserter that is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Kitee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

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# 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 offective as the predicate devices. The Opus Magnum SpeedScrew design and technology is substantially equivalent to the existing Arthrex PEEK SwiveLock and Opus Magnum PI Knotless Fixation Device cleared by the Food & Drug Administration [K061863 and K.070227 respectively]. The differences between the Opus Magnum SpeedScrew and the predicate devices do not raisc any questions regarding the safety and effectiveness of the implant. Furthermore, the materials arc well characterized and have been used in predicate devices with similar indications. The 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 new product, the Opus Magnum SpeedScrew Knotless Fixation Device. This new product is substantially equivalent to the Arthrex PEEK SwiveLock originally cleared under K061863, and the Opus Magnum PI Knotless Fixation Device originally cleared under K070227.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085

OCT 0 1 2008

Re: K081893 Trade/Device Name: Opus® Magnum SpeedScrew™ Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HWC Dated: July 2, 2008 Received: July 3, 2008

Dear Ms. Kasperowicz:

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 - Ms. Laura Kasperowicz.

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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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## INDICATIONS FOR USE STATEMENT

510(k) Number:

K 081893

Device Name:

Opus® Magnum SpeedScrew™ Knotless Fixation Device

Indications for Use:

The Opus Magnum SpeedScrew bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biccps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patcllar ligament and tendon avulsions

X

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

NO

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

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

510(k) Number

<081893