RESORBABLE NO PROFILE SCREW AND WASHER

K012469 · Biomet Manufacturing, Inc. · HWC · Dec 3, 2001 · Orthopedic

Device Facts

• Record ID: K012469
• Device Name: RESORBABLE NO PROFILE SCREW AND WASHER
• Applicant: Biomet Manufacturing, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resorbable No Profile Screw and Washer is indicated for the following procedures: 1. ACL and PCL reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. Iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Story

Resorbable No Profile Screw and Washer provides mechanical fixation for ligament and tendon repairs. Device consists of 6.5 mm diameter PLLA/PGA copolymer screw (25-55 mm lengths) and 18 mm diameter washer. Used by surgeons in orthopedic procedures; functions as primary or back-up fixation in ACL reconstruction to augment fixation strength in poor bone quality. Device is implanted during surgery; provides stability to soft tissue grafts during healing process. Resorbable material eliminates need for secondary removal surgery.

Clinical Evidence

No clinical data. Substantial equivalence established via bench mechanical testing.

Technological Characteristics

Material: PLLA/PGA copolymer. Dimensions: 6.5 mm diameter screw (25-55 mm length), 18 mm diameter washer. Principle: Mechanical bone fixation fastener. Resorbable material composition.

Indications for Use

Indicated for patients undergoing ACL/PCL reconstruction, medial/lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis reconstruction, or patellar ligament/tendon repair. Also indicated for back-up fixation in ACL reconstruction where bone quality is questionable.

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

• Arthrotek Interference Screw (K982497)
• Harpoon Suture Anchor (K943806/K973775)
• Sutureless Anchor (K984490)
• EndoPearl™ with Threader (K993339)

Submission Summary (Full Text)

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K01246951
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DEC 0 3 2001

Image /page/0/Picture/2 description: The image shows the logo for Biomet INC. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. The letters are connected to each other, and the "INC" is stacked vertically to the right of the "T". Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, serif font.

## SUMMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Arthrotek, Inc.<br>(A wholly owned subsidiary of Biomet, Inc.)<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Establishment Registration No.: 1825034 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sara B. Shultz<br>Biomet Manufacturing, Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Phone: [phone]<br>FAX: [phone] |
| Proprietary Name: | Resorbable No Profile Screw and Washer |
| Common or Usual Name: | resorbable screw and washer |
| Classification Name: | Screw, Fixation, Bone, Non-spinal, Non-metallic<br>(888.3040)<br>Washer, Bolt Nut, Non-spinal, Non-metallic<br>(888.3030) |

## Device Product Code: 87HWC and HTN

Legally Marketed Devices To Which Substantial Equivalence is Claimed: Arthrotek Interference Screw (Biomet, Inc., K982497), Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), Sutureless Anchor (Innovasive Devices, K984490), EndoPearl™ with Threader (Linvatec Corp., K993339)

Indications for Use: The Resorbable No Profile Screw and Washer is indicated for the following procedures:

- 1. ACL and PCL reconstruction
- 2. Medial collateral ligament repair
- 3. Lateral collateral ligament repair
- 4. Posterior oblique ligament repair
- 5. Iliotibial band tenodesis reconstruction
- 6. Patellar ligament and tendon repair

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

OFFICE 219.267.6639

FAX ■

Image /page/0/Picture/18 description: The image shows the number 000250, with the last digit being a 1. The numbers are in a bold, sans-serif font. The image is in black and white.

E-MAIL [e-mail]

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K012469581
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Image /page/1/Picture/1 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a bold, sans-serif font, with the letters connected to form a single shape. To the right of the word "BIOMET" is the word "INC" in a smaller font, stacked vertically. Below the logo is the phrase "CORPORATE HEADQUARTERS" in a smaller, serif font.

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Description: The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer. This device is comprised of a PLLA/PGA copolymer.

The device was designed to be used in conjunction with marketed devices such as resorbable or allograft interference screws in ACL reconstruction. The purpose of this back-up fixation will be to provide additional fixation strength in instances of questionable bone quality.

Summary of Technologies: The Resorbable No Profile Screw and Washer technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

> > 용

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

()FFICE 219.267.6639 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

E-MAIL [e-mail]

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Biomet Manufacturing, Corporation c/o Ms. Sara B. Shultz Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K012469

Trade/Device Name: Resorbable No Profile Screw and Washer Regulation Number: 888.3040 and 888.3030 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener and Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HWC and HTN Dated: October 24, 2001

Received: October 25, 2001

Dear Ms. Shultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninerce provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have boon recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 rr your device is olassined (600 as 10,000) of on the major regulations affecting your device can may or sabject to back as a sateral 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 r tease oe actives and i be reviewan that your device complies with other requirements of the Act

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## Page 2 - Ms. Sarah B. Shultz

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 listingPage (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

b. Mali N. Millison

Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0124691

Page **_ of _**

## 510(k) NUMBER (IF KNOWN):__KOLA 469

DEVICE NAME: Resorbable No Profile Screw and Washer

INDICATIONS FOR USE:

The Resorbable No Profile Screw and Washer is indicated for the following procedures:

- 1. ACL and PCL reconstruction
- 2. Medial collateral ligament repair
- 3. Lateral collateral ligament repair
- 4. Posterior oblique ligament repair
- 5. Iliotibial band tenodesis reconstruction
- 6. Patellar ligament and tendon repair

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off

Division of General, Restorative and Neurological Devices

510(k) Number

0000003

K01246