NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER

K051069 · Arthrotek, Inc. · MBI · Jun 29, 2005 · Orthopedic

Device Facts

• Record ID: K051069
• Device Name: NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
• Applicant: Arthrotek, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The tibial screws and washers are indicated for the following procedures: 1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (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

Nonresorbable CentraLoc™ Tibial Screw and Washer system designed for soft tissue-to-bone fixation; used in orthopedic ligament repair and reconstruction procedures. Device provides mechanical fixation; serves as primary or back-up fixation in ACL reconstruction to enhance strength in poor bone quality. Operated by surgeons in clinical/OR settings. Mechanical design is similar to predicate resorbable devices; nonresorbable material composition provides intended fixation stability.

Clinical Evidence

No clinical data. Substantial equivalence determined based on mechanical bench testing.

Technological Characteristics

Nonresorbable metallic bone fixation fastener. Mechanical design similar to resorbable predicate devices. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation during ACL/PCL reconstruction, medial/lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis, or patellar ligament/tendon repair. Also indicated as back-up fixation for ACL reconstruction in cases of questionable bone quality.

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

• LactoSorb® Tibial L-15 Screw and Washer – Arthrotek Inc. (K033233)
• LactoSorb - Tiblar L-15 Screw and Washer - Arthrotek Inc. (K021832)
• STALIF TT – Surgicraft Ltd. (K041617)

Submission Summary (Full Text)

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KOS1069

JUN 2 9 2005

Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a stylized, bold, sans-serif font. Each letter is outlined with a thick black border, giving the word a blocky and modern appearance. The letters are tightly spaced, creating a compact and unified design.

## 510(k) Summary

| Applicant/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 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Phone: [phone]<br>FAX: [phone] |
| Proprietary Name: | Nonresorbable CentraLoc™ Tibial Screw and Washer |
| Common Name: | Tibial screw and washer |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue. (21 CFR<br>§888.3040) |

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

LactoSorb® Tibial L-15 Screw and Washer – Arthrotek Inc. (K033233) LactoSorb - Tiblar L-15 Screw and Washer - Arthrotek İnc. (K021832) STALIF TT – Surgicraft Ltd. (K041617)

Device Description: The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of
the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.

## Intended Use:

The tibial screws and washers are indicated for the following procedures: lar screws and wasners are merceach (ACL) and posterior cruciate ligament (PCL) reconstruction Medial collateral ligament repair 2. 3. Lateral collateral ligament repair 115 SHIPPING ADDRESS MAILING ADDRESS 56 E. Bell Drive 120. Box 587 Warsaw, IN 46582 Warsaw, IN 46581-0587 E-MAIL FAX . ()FFICE 트 [e-mail] 574.267.8137 574.267.6639

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K051069

- 4. Posterior oblique ligament repair
- Iliotibial band tenodesis reconstruction 5.
- Patellar ligament and tendon repair 6.

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.

Summary of Technologies: The Nonresorbable CentraLoc™ Tibial Screws and Washers have the same intended use and indications for use as the predicate Lactosorb® Tibial L-15 Screw and Washer and No Profile Lactosorb® L-15 Screw and Washer devices. The mechanical design is similar to the predicate resorbable devices.

Non-Clinical Testing: Mechanical testing found the Nonresorbable CentraLoc™ Tibial Screw and Washer to be substantially equivalent to the predicate No Profile Lactosorb® L-15 Screw and Washer devices for the uses intended.

Clinical Testing: Clinical testing was not necessary to determine substantial equivalence for the Nonresorbable CentraLoc™ Tibial Screw and Washer.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrotek, Inc. C/o Mr. Gary Baker Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K051069

K031007
Trade/Device Name: Nonresorbable CentraLoc™ Tibial Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: April 25, 2005 Received: April 26, 2005

Dear Mr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became re(i) fee device is substantially equivalent (for the indications felerenced above and nave actering as a losses and the same of the marketed in interstate for use stated in the encrosary w regars and ment date of the Medical Device Amendments, or to commence pror to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not requent of the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 If your device is classified (soc above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Gods incements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meant 1 icase be advised that i Dri brisan that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of ally it cachates and regulations and aincluding, but not limited to: registration and listing (21 Comply with an the Aot 8 requirements, and manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Gary Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maxing of substantial equivalence of your device to a legally premarket notheadon: "The PDF intellig sification 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 If you desire specific advice for your as (240) 276-__. Also, please note the regulation entitled, Collider the Office of Compunise market notification" (21CFR Part 807.97). You may obtain Misoranting of Telefone to prenantonibilities under the Act from the Division of Small other general information on your respense Assistance at its toll-free number [phone] or Manufacturers, International and Octoss http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Stupt Rurds

Rt. Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. Acting 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

Page 1 of 1

0(k) Number (if known):_______________________________________________________________________________________________________________________________________________________

evice Name: Nonresorbable CentraLoc™ Tibial Screw and Washer

dications For Use:

- 1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction
- Medial collateral ligament repair 2.
- 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.

escription Use X art 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hipt Lurdes

Division of General, Restorative, and Neurological Devices

510(k) Number K051069