REPICCI II UNICONDYLAR KNEE SYSTEM

K020264 · Biomet Orthopedics, Inc. · HRY · Feb 8, 2002 · Orthopedic

Device Facts

• Record ID: K020264
• Device Name: REPICCI II UNICONDYLAR KNEE SYSTEM
• Applicant: Biomet Orthopedics, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Feb 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Repicci IITM Unicondylar Knee System is for use with bone cement.

Device Story

Repicci II™ Unicondylar Knee System is a cemented, semi-constrained knee prosthesis; intended for surgical implantation in patients with degenerative or traumatic knee joint conditions. Device consists of femoral and tibial components; features include an intermediate 51mm femoral size and Ti-6Al-4V plasma spray porous coating on component interiors. System is used by orthopedic surgeons in clinical/hospital settings to replace damaged joint surfaces; restores joint function and reduces pain. Substantial equivalence established via Finite Element Analysis (FEA) comparing design, materials, and sizing to predicate.

Clinical Evidence

No clinical testing was provided as a basis for substantial equivalence. Evidence consists of bench testing via Finite Element Analysis (FEA).

Technological Characteristics

Semi-constrained, cemented knee prosthesis. Materials include metal and polymer components with Ti-6Al-4V plasma spray porous coating on interior surfaces. Design includes multiple sizes, including a 51mm intermediate femoral component. Operates as a mechanical joint replacement.

Indications for Use

Indicated for patients with painful and disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments; patients requiring correction of varus, valgus, or posttraumatic deformity; and patients requiring revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. For use with bone cement.

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

• Repicci IITM Unicondylar Knee (K971938)

Submission Summary (Full Text)

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FEB 0 8 2002

Image /page/0/Picture/1 description: The image shows the Biomet corporate headquarters logo. The logo includes the word "BIOMET" in a stylized font, with the letters connected to each other. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, sans-serif font. To the left of the logo, the number "2002" is written in a bold font.

020264/
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## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Biomet Orthopedics, Inc.<br>56 East Bell Drive<br>Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Telephone: [phone] |
| Proprietary Name: | Repicci II™ Unicondylar Knee System |
| Common Name: | Repicci II™ Unicondylar Porous Knee |

Classification: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560).

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Repicci IITM Unicondylar Knee (K971938)

Device Description: The Repicci II™ Unicondylar Porous Knee is the same as the predicate, the Repicci III™ Unicondylar Knee (K971938), except for the additions of an intermediate sized femoral component -- 51mm and Ti-6Al-4V plasma spray porous coating to the interior of the components.

Indications for Use: The indications for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Repicci IITM Unicondylar Knee System is for use with bone cement.

Summary of Technologies: The Repicci II™ Unicondylar Knee System componentsthe materials, design, sizing, and indications are similar or identical to the predicate devices.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

000070

OFFICE 219.267.6639 FAX [phone] E = = =

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Non-Clinical Testing: A Finite Element Analysis (FEA) with a Engineering Justification determined that the Repicci II™ Unicondylar Knee System components presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

K020264
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 8 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K020264

Trade Name: Repicci IITM Unicondylar Porous Knee Regulation Number: 888.3530 Regulation Name: Knee Joint, Femorotibial Metal/Polymer Semiconstrained Cemented Prosthesis Regulatory Class: II Product Code: HRY Dated: December 19, 2001 Received: January 25, 2002

Dear Ms. Binkley:

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 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. Dalene T. Binkley

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,

. Mark A. Mulhim

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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Page of

510 (k) NUMBER (IF KNOWN): __________________________________________________________________________________________________________________________________________________

DEVICE NAME: Repicci II™ Unicondylar Knee System

INDICATIONS FOR USE:

The indications for use for the Repicci II™ Unicondylar Knee System are for painful and The Indications for use for the Replect in - Otheonomic arthritis. traumatic arthritis where one or more compartments are involved: the correction of varys. valgus, of where one of more companinents are moved of unsuccessful osteotomy. positiatinatie defent of previous joint replacement procedure.

This device is for use with bone cement.

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

| | | | Concurrence of CDRH. Office of Device Evaluation (ODE) |
|----------------------|-----------------------------------------|----|--------------------------------------------------------|
| Prescription Use | <div style="text-align:center;">X</div> | OR | Over-The-Counter-Use |
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

for

| (Division Sign-Off) | Mark N Melber |
|-----------------------------------------------------------|---------------|
| Division of General, Restorative and Neurological Devices | |

| 510(k) Number | K020264 |
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