REPICCI LOCKED KEEL TIBIAL BEARING

K030446 · Biomet, Inc. · HRY · Mar 6, 2003 · Orthopedic

Device Facts

• Record ID: K030446
• Device Name: REPICCI LOCKED KEEL TIBIAL BEARING
• Applicant: Biomet, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Mar 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The devices covered in this 510(k) are intended to be used with Repicci® Femoral Components. The device is a single use implant intended for implantation with bone cement.

Device Story

Repicci™ Locked Keel Tibial Bearing is an all-polyethylene unicondylar knee tibial component; designed for partial knee replacement. Device features anatomical geometry with right/left medial/lateral allocations; includes inferior surface with fixation holes and a locked keel. Implanted via bone cement; used in conjunction with Repicci™ Femoral Components. Intended for use by orthopedic surgeons in clinical settings. Device replaces articulating surfaces of knee joint affected by degenerative disease or trauma. Modification from predicate involves keel design and removal of waffle pattern on inferior surface.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence; engineering justification used.

Technological Characteristics

All-polyethylene tibial component; anatomical geometry; features fixation holes and a locked keel. Designed for cemented fixation. Single-use implant.

Indications for Use

Indicated for patients requiring partial knee replacement due to compartmental primary degenerative disease, post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Worland Unicondylar All Poly Tibial Bearing (K011795)

Reference Devices

• Repicci™ Femoral Components (K971938)

Submission Summary (Full Text)

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BIOMET

030446
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## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | MAR 0 6 2003 |
|-------------------|-------------------------------------------------------------------|--------------|
| Contact Person: | Tracy J. Bickel<br>[phone] | |
| Proprietary Name: | Repicci™ Locked Keel Tibial Bearing | |
| Common Name: | Unicompartmental Knee Tibial Component | |

Classification Name: Prosthesis, Knee, Femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.350)

Substantially Equivalent Devices: Worland Unicondylar All Poly Tibial Bearing -- K011795

The Repicci II® Unicondylar Knee System consists of a femoral and tibial Device Description: component. The Repicci™ tibial bearing is used with the Repicci™ femoral components (K971938).

The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a face with fixation holes and a keel.

Intended Use: Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.

The device is a single use implant intended for implantation with bone cement.

Summary of Technologies: The Repicci™ Locked Keel Tibial components materials, design, sizing, and indications are similar to, or identical to the predicate devices. This submission modifies the keel on the inferior surface of the implant and removes the waffle pattern.

Non-Clinical Testing: An engineering justification determined that the Repicci™ Locked Keel tibial components presented no new risks and were; therefore, substantially equivalent to the predicate device.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

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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 features a stylized eagle head in profile, composed of three curved lines. The eagle faces right, and the lines suggest feathers and the shape of the head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAR 0 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K030446

Trade/Device Name: Repicci™ Locked Keel Tibial Bearing Regulation Number: 21 CFR 888.3530 Regulation Names: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 7, 2003 Received: February 11, 2003

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 (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

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Page 2- Ms. Tracy J. Bickel

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), 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 vours.

Mark A. Mulkerson

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: Repicci™ Unicondylar Tibial Bearings Indications for Use:

Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered in this 510(k) are intended to be used with Repicci® Femoral Components.

The device is a single use implant intended for implantation with bone cement.

for Mark A. Mulkerson

Di ision of General, Restorative and Neurological Devices

KO30446 710(k) Number _

(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)