OPUS MINIMAGNUM ANCHOR WITH INSERTER

K042584 · Opus Medical, Inc. · HWC · Dec 14, 2004 · Orthopedic

Device Facts

• Record ID: K042584
• Device Name: OPUS MINIMAGNUM ANCHOR WITH INSERTER
• Applicant: Opus Medical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opus MiniMagnum™ 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 reattachment 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

Bone anchor system for soft tissue-to-bone fixation; used in orthopedic surgical procedures (shoulder, ankle, foot, elbow, knee). Device consists of anchor and inserter instrument. Surgeon deploys anchor into bone to secure soft tissue. Provides mechanical fixation to facilitate healing. Used in clinical/OR settings by orthopedic surgeons. Benefits patient by enabling stable tissue reattachment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; non-degradable; includes anchor and inserter instrument; mechanical fixation principle.

Indications for Use

Indicated for fixation of soft tissue to bone in orthopedic procedures including shoulder (e.g., rotator cuff, Bankart, SLAP), ankle (e.g., Achilles, instability), foot (e.g., hallux valgus), elbow (e.g., tennis elbow), and knee (e.g., 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™ Anchor (K012125)
• Mitek BioKnotless Anchor

Submission Summary (Full Text)

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Opus Medical, Inc.

510(k) Notification

MiniMagnum™ Bone Anchor and Instrument Set Page 9 of Sin

DEC 1 4 2004

Section 4: 510(k) Summary

510(k) Number:

K043584

page 1 of 2

#### Substantial Equivalence

Substantial Equitements of 21 CFR 807.93, this summary is formatted with the In accordance with the requirements and 510(k) Statements... " and can be used to provide equivalence summary to anyone requesting it from the Agency.

| Manufacturer: | Opus Medical, 27127 Calle Arroyo, Suite 1924<br>San Juan Capistrano, CA. 92675 |
|-----------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Laura Kasperowicz, Ph: [phone], Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | September 20, 2004 |

### Device Information

| Trade Name: | Opus MiniMagnum™ 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 MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone.

## Indications For Use

The Opus MiniMagnum™ 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 reattachment

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

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Opus Medical, Inc.

510(k) Notification

Section 4: 510(k) Summary

**510(k) Number:** K045584

page 2 of 2

# Executive Summary and Reason for 510(k) Notification

Executive Sullimary and Reason ior erra of a new Opus product, the Opus I he purpose of this STU(K) is to nothy the PDF of the " substantially equivalent to Opus MiniMagnum™ originally cleared under 510(k) 012125, but is smallers in size. The intended use and Magnum !™ originally cleared under 310(x) 012125, oat be Mick BioKnotless Bone Anchor.
indications for use are the same as the predicate device, the Michaetially indications for use are the same as the predicate do november System is substantially I he rundaniental technology of the Opus Magnum™ Bone Anchor.

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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 features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

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

Re: K042584

Trade/Device Name: Opus MiniMagnum™ Bone Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 21, 2004 Received: September 22, 2004

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 N. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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. Mcllussen

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

SECTION 3: STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K042584

Device Name: Opus MiniMagnum™ Bone Anchor with Inserter

Indications for Use:

The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.

Examples of such procedures include:

Ελαπίριο στ such proved. SLAP Iesion repair, acromio-clavicular separation, rotator cuff Onounter - Banklift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair 1 count, expons sinfe bappen one in instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique I's ligament or joint capsule co anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Prescription Use X (Per CFR 801.109)

OR

Over-The-Counter Use No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K042584

510(k) Number