WORLAND UNICONDYLAR TIBIAL BEARING

K011795 · Biomet, Inc. · HRY · Jun 13, 2001 · Orthopedic

Device Facts

• Record ID: K011795
• Device Name: WORLAND UNICONDYLAR TIBIAL BEARING
• Applicant: Biomet, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Jun 13, 2001
• 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

Worland Unicondylar Tibial Bearing is an all-polyethylene tibial component for partial knee replacement; used in conjunction with Repicci™ Femoral Components. Implant features anatomical geometry with right/left medial/lateral allocations; inferior surface includes patterned face with holes and fin. Device is single-use; implanted via bone cement. Intended for patients with single-compartment knee joint disease. Surgeon performs implantation during orthopedic procedure. Device restores articulating surfaces of knee joint.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence. Evidence limited to bench testing (fatigue testing and stress analysis).

Technological Characteristics

All-polyethylene tibial component; anatomical geometry; inferior surface features patterned face with holes and fin. Designed for use with bone cement. 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, joint 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

• Repicci II™ Unicondylar All Poly Tibial Bearing (K980665)

Reference Devices

• Repicci™ Femoral Components (K971938)

Submission Summary (Full Text)

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JUN 1 3 2001

## CORPORAT ARTERS

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-------------------|-------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel<br>[phone] |
| Proprietary Name: | Worland Unicondylar 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: Repicci II™ Unicondylar All Poly Tibial Bearing - K980665

The Repicci IITM Unicondylar Knee System consists of a femoral and tibial Device Description: component. The Worland tibial bearing is used with the Repicci II™ 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 patterned face with holes and a fin.

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 w/ bone cement.

Summary of Technologies: The Worland Unicondylar Tibial components materials, design, sizing, and indications are similar to or identical to the predicate devices.

Non-Clinical Testing: Fatigue testing and stress analysis determined that the Worland Unicondylar Tibular 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.

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

D

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 219.267.6639

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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human profile.

Public Health Service

JUN 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Bickel Regulatory Specialist Biomet, Inc 56 Bell Drive Warsaw, Indiana 46582

Re: K011795

Trade Name: Worland Unicondylar Tibial Bearing Regulation Number: 888.3560 Regulatory Class: II Product Code: HRY Dated: June 7, 2001 Received: June 8, 2001

Dear Ms. Bickel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 - Ms. Tracy Bickel

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Bmt chelltmo for

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: Worland 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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div style="text-align:center">Втыелмено от слиш</div> |
|--------------------------------------------------------|----------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| | K011795 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR |
| | 510(k) Number Over-The-Counter Use<br>(Optional Format 1-2-96) |
| | 000008 |