ARTHROTEK LACTONAIL

K040500 · Arthrotek, Inc. · HTY · May 25, 2004 · Orthopedic

Device Facts

• Record ID: K040500
• Device Name: ARTHROTEK LACTONAIL
• Applicant: Arthrotek, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. Indications include the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

Device Story

Arthrotek® LactoNail™ is a bioabsorbable bone fixation nail used to maintain alignment of small bone fragments. Constructed from a resorbable PLLA/PGA copolymer; available in 1.6, 2.0, and 2.6mm diameters and four lengths. Used by surgeons during arthroscopy or open surgery to stabilize non-load bearing bone fragments, osteotomies, and arthrodesis sites. Device provides mechanical fixation during the healing process and is designed to resorb over time, eliminating the need for secondary removal surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Resorbable copolymer composed of PLLA/PGA. Diameters: 1.6, 2.0, 2.6mm. Lengths: 14, 18, 21, 26mm. Mechanical fixation device.

Indications for Use

Indicated for fixation of non-load bearing bone fractures, osteotomies, and arthrodesis, including apical, osteochondral, and cancellous fragments.

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

• SmartPin™ (K925098)

Submission Summary (Full Text)

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MAY 2 5 2004

K040500
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Image /page/0/Picture/2 description: The image shows the logo for ARTHROTEK, a Biomet Company. The logo is in black and white, with the word "ARTHROTEK" in large, bold letters. The "O" in ARTHROTEK is replaced by a solid black circle. Below the company name, in smaller letters, it says "A BIOMET COMPANY".

### CORPORATE HEADQUARTERS

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Tracy J. Bickel, RAC Contact Person: Regulatory Associate

Proprietary Name: Arthrotek® LactoNail™

Common Name: resorbable bone fixation nail

Classification Code: HTY

Classification Name: Pin, Fixation, Smooth (888.3040)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: SmartPin™ (Bionx Implants) - K925098

Device Description: The Arthrotek® LactoNail™ bioabsorbable bone fixation nail is Device Deseription. The Archives
constructed of a resorbable copolymer composed of PLLA/ PGA. The device is available in 1.6, 2.0, and 2.6mm diameters. The LactoNail™ comes in four (4) lengths (14, 18, 110/ 210/ 210/ and 26mm). Arthrotek® LactoNail™ maintains alignment of small bone fractures and apical fragments, osteochondral fragments and cancellous/non-load bearing fragments following arthroscopy or open surgery.

Indications for Use: The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. fragments of nuctured non load beaning of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

Summary of Technologies: The Arthrotek® LactoNail™ is similar to or identical in terms of material, function, labeling, and sizing to the predicate SmartPin™ (K925098).

Non-Clinical Testing: Mechanical testing was performed on the Arthrotek® LactoNail™ ron Cirment Testing Preshiban (600mg 100.). The testing demonstrates that the Arthrotek® LactoNail™ is substantially equivalent to the predicate.

Clinical Testing: Clinical testing was not required for this product.

All trademarks are property of Arthrotek, Inc. unless otherwise noted SmartPin is a trademark of Bionx Implants Inc. 56 E. Bell Drive

()FFICE 219 267 6639

F-MAIL arthrotek&geurthrotek.com

દપ્પ

Warsaw, IN 46582

PAX 219.372.1718

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Ms. Tracy J. Bickel, RAC Regulatory Associate Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581

Re: K040500

Trade/Devicc Name: Arthrotek® LactoNail™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: February 25, 2004 Received: February 27, 2004

Dear Ms. Bickel:

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 (sec 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 I'DA'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. Tracy J. Bickel, RAC

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 vours,

Sincerely yours,

Mark N Mllhurn

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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# Indications for Use

#### Ko40500 510(k) Number (if known):

Device Name: Artrhotek® LactoNail™

## Indications For Use:

The Arthrotek® LactoNail™ is intended for use in the fixation of fragments of fractured The Arthrotek® Lactoriali - Is intended for ass in assommes include the fixation of non-load bearing bones, osteocomics, and arthrousser assistential.
apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerron

Division of General, Restorative, and Neurological Devices

510(k) Number K040500

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