LACTOSORB TIBIAL L-15 SCREW AND WASHER

K033233 · Biomet, Inc. · HWC · Nov 5, 2003 · Orthopedic

Device Facts

• Record ID: K033233
• Device Name: LACTOSORB TIBIAL L-15 SCREW AND WASHER
• Applicant: Biomet, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LactoSorb® Tibial L-15 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 bone fixation device consisting of screw and washer; composed of 85% L-Lactide/15% Glycolide copolymer. Used by surgeons in orthopedic procedures to secure soft tissue to bone. Fixation achieved by sandwiching soft tissue between washers and screwing into bone. Provides primary or back-up fixation strength in ligament/tendon repairs and reconstructions. Benefits patient by providing necessary mechanical stability during healing process without requiring permanent metallic hardware.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (mechanical pull-out testing).

Technological Characteristics

Resorbable screw and washer system; material: 85% L-Lactide/15% Glycolide copolymer. Mechanical fixation via screw-in mechanism. Non-metallic.

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 Resorbable No-Profile LactoSorb® L-15 Screw and Washer (K021832)

Submission Summary (Full Text)

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033233 1/2

NOV - 5 2003

BIOMET

## 510(k) Summary

Applicant/Sponsor:Biomet Orthopedics, Inc.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: LactoSorb® Tibial L-15 Screw and Washer

Common Name: Non-metallic screw and washer

Classification Name: Screw, Fixation, Bone, Non-Spinal, Non-Metallic (21 CFR 888.3040

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer cleared in 510(k) K021832).

Device Description: The device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:

- · Resorbable screw in varying diameters
- Screw pre-assembled with a washer .
- Fixation achieved by sandwiching the soft tissue between the two washers . and screwing into the bone
- 85% L-Lactide/15% Glycolide copolymer .

Intended Use: The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:

1-11

574.267.8137

- 1. ACL and PCL reconstruction
- 2. Medial collateral ligament repair
- 3. Lateral collateral ligament repair
- 4. Posterior oblique ligament repair

E

574.267.6639

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

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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 overall design, materials and processing methods are similar to the predicate device

Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device.

Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, featuring three curved lines above a wavy line.

Public Health Service

NOV = 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578

K033233 Re:

> Trade Name: LactoSorb® Tibial L-15 Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: October 1, 2003 Received: October 6, 2003

Dear Ms. Beres:

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 requiréments 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. Patricia Sandborn Beres

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 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,

Sincerely yours,

Mark N Mulhearn

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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510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________

## DEVICE NAME: LactoSorb® Tibial L-15 Screw and Washer

INDICATIONS FOR USE:

The LactoSorb® Tibial L-15 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)

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

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

510(k) Number

11

OR